Bipolar Disorder, Epilepsy
Conditions
Keywords
Pregnancy registry, Major congenital malformations, Pregnancy outcomes, Pregnancy, First trimester, Lamotrigine
Brief summary
Antiepileptic drugs (AEDs) are not indicated for use in pregnancy. However, women with epilepsy, and other approved indications including bipolar disorder, may require or be unintentionally exposed to AEDs during pregnancy. Prior to an AED being marketed there are few data available on drug safety in pregnancy: data from animal models may not translate directly to humans and pregnant women are routinely excluded from clinical trials. The International Lamotrigine Pregnancy Registry was established by GlaxoSmithKline (GSK) in 1992 to monitor the safety of lamotrigine during pregnancy.
Detailed description
The International Lamotrigine Pregnancy Registry aims to assess whether there is a substantial increase in the risk of major congenital malformations (MCMs) following in utero exposure to lamotrigine. Exposure during the first trimester is of primary interest as this represents the period of organogenesis. The Registry is a primarily prospective enrolment and follow-up study. Patients exposed to lamotrigine during pregnancy are enrolled, on a voluntary basis, by their healthcare provider. Enrolment is encouraged early in pregnancy and if possible prior to any prenatal testing. The healthcare provider provides initial information concerning patient demographics; details of the pregnancy including the estimated delivery date and results of any prenatal testing; and the timing, duration and dosage of lamotrigine exposure in pregnancy. The registry accepts exposure reports from anywhere in the world. Within the United States (US) the healthcare provider can contact the registry using a toll free number. Outside of the US enrolments are made through the GlaxoSmithKline local operating company. Close to the estimated date of delivery the healthcare provider is contacted by the Registry to provide follow up information concerning the pregnancy outcome (live or still birth, spontaneous or induced abortion), the presence or absence of a MCM, and the history of exposure to lamotrigine as well other antiepileptics and antipsychotics during pregnancy. Up to six attempts are made to contact the healthcare provider to obtain pregnancy outcome information. After six attempts, the record is closed as lost to follow up. Pregnancy outcomes are classified as outcomes with MCMs, outcomes without MCMs and spontaneous abortions. The outcomes with and without MCMs are further classified as live births, stillbirths/fetal deaths and induced abortions. Spontaneous abortions are reported separately due to potential for inconsistent identification of malformations in that situation. It is beyond the scope of the Registry to consistently access pediatric evaluations and medical records. For this reason the main outcome is restricted to major congenital malformations that are external and recognizable in the delivery room or shortly after birth. To provide consistency, reported congenital malformations are classified as major or minor according to criteria used by the Centers for Disease Control and Prevention (CDC)'s Metropolitan Atlanta Congenital Defects Program (MACDP). All malformation reports are reviewed and classified by a paediatrician from the CDC and further information is requested as necessary. Analyses are restricted to prospectively enrolled pregnancies (enrolment prior to knowledge of the birth outcome). Retrospectively enrolled pregnancies are reviewed for patterns of defect types, but are not included in formal analyses as retrospective reporting can be biased towards more unusual and severe outcomes and are less likely to be representative of the general population experience. The proportion of infants with MCMs among prospectively reported exposures is calculated as: the total number of outcomes with major birth defects (number of outcomes with major birth defects + the number of live births without defects). Chromosomal malformations are reported descriptively, but are not included in the numerator as it is very unlikely that they are associated with drug exposure during pregnancy. All spontaneous pregnancy losses, as well as induced abortions and fetal deaths without reported defects, are excluded from the denominator due to the potential for inconsistent identification of malformations in those situations. The 95% confidence intervals (CIs) for risk estimates are calculated using exact methods based on the binomial distribution. Analyses are stratified according to trimester of exposure (with the second trimester starting at week 14 and the third trimester at week 28 of gestation) and by exposure group (lamotrigine monotherapy, lamotrigine polytherapy including valproate and lamotrigine polytherapy without valproate). The registry does not have an internal comparator group, but descriptive comparisons are made with MCM rates from general population studies in the literature and from other ongoing AED pregnancy registries. Prospective reports are also reviewed to detect any unusual patterns of malformation types that may warrant further investigation. The data from the International Lamotrigine Pregnancy Registry are reviewed, and conclusions developed, by an independent scientific advisory committee. A semi-annual interim report summarizing aggregate data is provided to disseminate information on a regular basis.
Interventions
Lamotrigine monotherapy
DRUGLamotrigine polytherapy including valproate
Lamotrigine polytherapy including valproate
DRUGLamotrigine polytherapy without valproate
Lamotrigine polytherapy without valproate
Sponsors
GlaxoSmithKline
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
No
Inclusion criteria
* Women exposed in utero to lamotrigine (as monotherapy or in a polytherapy combination) during pregnancy. Exposure can occur at any time during pregnancy, though exposure in the first trimester is of primary interest. * Pregnancies exposed to lamotrigine and reported before the outcome of the pregnancy is known (prospective reporting). Ideally exposed pregnancies are registered prior to prenatal testing, but only those pregnancies enrolled after prenatal testing has diagnosed a birth defect are excluded. * Retrospectively reported exposures (i.e. exposures registered once the pregnancy outcome is known) are included in the registry, but are considered descriptively and are not included in risk analyses.
Exclusion criteria
* Retrospectively reported exposures (i.e. exposures registered once the pregnancy outcome is known) are included in the registry, but are reviewed separately and descriptively. These are not included in risk analyses. * Patient reported exposures and outcomes that are not verified by a healthcare provider.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Birth Outcomes by Earliest Pregnancy Trimester of Exposure to Lamotrigine Monotherapy | Although reports and diagnoses of major congenital malformations are accepted up to six years after the birth, the majority of malformations are reported after assessments made in the delivery room or shortly after birth | The number of live births, fetal deaths, induced abortions, and spontaneous pregnancy losses were recorded according to the time at which women were first exposed to lamotrigine monotherapy. Due to inconsistent identification of major congenital malformations (MCMs) among spontaneous losses, no comment is made concerning the presence or absence of MCMs. |
| Birth Outcomes by Earliest Pregnancy Trimester of Exposure to Lamotrigine Polytherapy With Valproate | Although reports and diagnoses of MCMs are accepted up to six years after the birth, the majority of malformations are reported following assessments made in the delivery room or shortly after birth | The number of live births, fetal deaths, induced abortions, and spontaneous pregnancy losses were recorded according to the time at which women were first exposed to lamotrigine polytherapy with valproate. Due to inconsistent identification of major congenital malformations (MCMs) among spontaneous losses, no comment is made concerning the presence or absence of MCMs. |
| Birth Outcomes by Earliest Pregnancy Trimester of Exposure to Lamotrigine Polytherapy Without Valproate | Although reports and diagnoses of MCMs are accepted up to six years after the birth, the majority of malformations are reported following assessments made in the delivery room or shortly after birth | The number of live births, fetal deaths with pregnancy loss occurring \>=20 weeks gestation, induced abortions, and spontaneous pregnancy losses were recorded according to the time at which women were first exposed to lamotrigine polytherapy without valproate. Due to inconsistent identification of major congenital malformations (MCMs) among spontaneous losses, no comment is made concerning the presence or absence of MCMs. Although birth defects may not have been reported, they cannot be ruled out. |
| Number of Infants With Major Congenital Malformations by Earliest Trimester of Exposure to Lamotrigine Monotherapy | Although reports and diagnoses of MCMs are accepted up to six years after the birth, the majority of malformations are reported after assessments made in the delivery room or shortly after birth | Among lamotrigine monotherapy exposures: live births, fetal deaths, induced abortions with birth defects, and live births without defects. Due to the likelihood of inconsistent identification of birth defects among spontaneous losses, fetal deaths, and induced abortions without reported birth defects, these offspring were not included in analyses. |
| Number of Infants With Major Congenital Malformations (MCMs) by Earliest Trimester of Exposure to Lamotrigine Polytherapy With Valproate | Although reports and diagnoses of MCMs are accepted up to six years after the birth, the majority of malformations are reported following assessments made in the delivery room or shortly after birth | The number of infants with major congenital malformations were counted and are presented by earliest trimester of exposure to lamotrigine polytherapy with valproate. |
| Number of Infants With Major Congenital Malformations (MCMs) by Earliest Trimester of Exposure to Lamotrigine Polytherapy Without Valproate | Although reports and diagnoses of MCMs are accepted up to six years after the birth, the majority of malformations are reported following assessments made in the delivery room or shortly after birth | The number of infants with major congenital malformations were counted and are presented by earliest trimester of exposure to lamotrigine polytherapy without valproate. |
| Number of Infants With the Indicated Major Congenital Malformations Following the First Trimester of Exposure to Lamotrigine Monotherapy According to Dose Received | Although reports and diagnoses of MCMs are accepted up to six years after the birth, the majority of malformations are reported after assessments made in the delivery room or shortly after birth | The number of infants with the reported MCM following first trimester lamotrigine monotherapy exposure were counted. Registry personnel contacted the enrolling physician to obtain information on the pregnancy outcome, lamotrigine dosing and duration of exposure, and use of concomitant antiepileptic drugs during pregnancy. |
| Number of Infants With the Indicated Major Congenital Malformations Following First Trimester of Exposure to Lamotrigine Polytherapy With Valproate According to Dose of Lamotrigine Received | Although reports and diagnoses of MCMs are accepted up to six years after the birth, the majority of malformations are reported after assessments made in the delivery room or shortly after birth | The number of infants with the reported MCM following first trimester exposure to lamotrigine polytherapy with valproate were counted. |
| Number of Infants With the Indicated Major Congenital Malformations Following First Trimester of Exposure to Lamotrigine Polytherapy Without Valproate According to Dose of Lamotrigine Received | Although reports and diagnoses of MCMs are accepted up to six years after the birth, the majority of malformations are reported after assessments made in the delivery room or shortly after birth | The number of infants with the reported MCM following first trimester exposure to lamotrigine polytherapy without valproate were counted. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Lamotrigine Monotherapy Pregnancy Exposures Prospectively enrolled pregnancies exposed to lamotrigine monotherapy at doses between 0-1200 mg/day | 2,567 |
| Lamotrigine Polytherapy With Valproate Pregnancy Exposures Prospectively enrolled pregnancies exposed to lamotrigine polytherapy with valproate, all dose ranges | 219 |
| Lamotrigine Polytherapy Without Valproate Pregnancy Exposures Prospectively enrolled pregnancies exposed to lamotrigine polytherapy without valproate, all dose ranges | 630 |
| Total | 3,416 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 791 | 48 | 133 |
Baseline characteristics
| Characteristic | Lamotrigine Monotherapy Pregnancy Exposures | Lamotrigine Polytherapy With Valproate Pregnancy Exposures | Lamotrigine Polytherapy Without Valproate Pregnancy Exposures | Total |
|---|---|---|---|---|
| Age Continuous | 27.9 years STANDARD_DEVIATION 5.84 | 25.8 years STANDARD_DEVIATION 5.49 | 28.1 years STANDARD_DEVIATION 6.08 | 27.8 years STANDARD_DEVIATION 5.89 |
| Sex: Female, Male Female | 2567 Participants | 219 Participants | 630 Participants | 3416 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 35 / 1,776 | 16 / 171 | 12 / 497 |
Outcome results
Primary
Birth Outcomes by Earliest Pregnancy Trimester of Exposure to Lamotrigine Monotherapy
The number of live births, fetal deaths, induced abortions, and spontaneous pregnancy losses were recorded according to the time at which women were first exposed to lamotrigine monotherapy. Due to inconsistent identification of major congenital malformations (MCMs) among spontaneous losses, no comment is made concerning the presence or absence of MCMs.
Time frame: Although reports and diagnoses of major congenital malformations are accepted up to six years after the birth, the majority of malformations are reported after assessments made in the delivery room or shortly after birth
Population: Prospectively enrolled pregnancies exposed to lamotrigine monotherapy.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| First Exposure During First Trimester | Birth Outcomes by Earliest Pregnancy Trimester of Exposure to Lamotrigine Monotherapy | Live Birth (Birth Defects Reported) | 31 infants |
| First Exposure During First Trimester | Birth Outcomes by Earliest Pregnancy Trimester of Exposure to Lamotrigine Monotherapy | Induced Abortion (No Birth Defects Reported) | 33 infants |
| First Exposure During First Trimester | Birth Outcomes by Earliest Pregnancy Trimester of Exposure to Lamotrigine Monotherapy | Fetal Death (No Birth Defects Reported) | 10 infants |
| First Exposure During First Trimester | Birth Outcomes by Earliest Pregnancy Trimester of Exposure to Lamotrigine Monotherapy | Fetal Death (Birth Defects Reported) | 1 infants |
| First Exposure During First Trimester | Birth Outcomes by Earliest Pregnancy Trimester of Exposure to Lamotrigine Monotherapy | Spontaneous Pregnancy Loss | 98 infants |
| First Exposure During First Trimester | Birth Outcomes by Earliest Pregnancy Trimester of Exposure to Lamotrigine Monotherapy | Induced Abortion (Birth Defects Reported) | 3 infants |
| First Exposure During First Trimester | Birth Outcomes by Earliest Pregnancy Trimester of Exposure to Lamotrigine Monotherapy | Live Birth (No Birth Defects Reported) | 1523 infants |
| First Exposure During Second Trimester | Birth Outcomes by Earliest Pregnancy Trimester of Exposure to Lamotrigine Monotherapy | Induced Abortion (No Birth Defects Reported) | 0 infants |
| First Exposure During Second Trimester | Birth Outcomes by Earliest Pregnancy Trimester of Exposure to Lamotrigine Monotherapy | Live Birth (No Birth Defects Reported) | 91 infants |
| First Exposure During Second Trimester | Birth Outcomes by Earliest Pregnancy Trimester of Exposure to Lamotrigine Monotherapy | Induced Abortion (Birth Defects Reported) | 0 infants |
| First Exposure During Second Trimester | Birth Outcomes by Earliest Pregnancy Trimester of Exposure to Lamotrigine Monotherapy | Fetal Death (No Birth Defects Reported) | 0 infants |
| First Exposure During Second Trimester | Birth Outcomes by Earliest Pregnancy Trimester of Exposure to Lamotrigine Monotherapy | Spontaneous Pregnancy Loss | 0 infants |
| First Exposure During Second Trimester | Birth Outcomes by Earliest Pregnancy Trimester of Exposure to Lamotrigine Monotherapy | Fetal Death (Birth Defects Reported) | 0 infants |
| First Exposure During Second Trimester | Birth Outcomes by Earliest Pregnancy Trimester of Exposure to Lamotrigine Monotherapy | Live Birth (Birth Defects Reported) | 4 infants |
| First Exposure During Third Trimester | Birth Outcomes by Earliest Pregnancy Trimester of Exposure to Lamotrigine Monotherapy | Live Birth (No Birth Defects Reported) | 17 infants |
| First Exposure During Third Trimester | Birth Outcomes by Earliest Pregnancy Trimester of Exposure to Lamotrigine Monotherapy | Live Birth (Birth Defects Reported) | 1 infants |
| First Exposure During Third Trimester | Birth Outcomes by Earliest Pregnancy Trimester of Exposure to Lamotrigine Monotherapy | Fetal Death (Birth Defects Reported) | 0 infants |
| First Exposure During Third Trimester | Birth Outcomes by Earliest Pregnancy Trimester of Exposure to Lamotrigine Monotherapy | Induced Abortion (Birth Defects Reported) | 0 infants |
| First Exposure During Third Trimester | Birth Outcomes by Earliest Pregnancy Trimester of Exposure to Lamotrigine Monotherapy | Fetal Death (No Birth Defects Reported) | 0 infants |
| First Exposure During Third Trimester | Birth Outcomes by Earliest Pregnancy Trimester of Exposure to Lamotrigine Monotherapy | Induced Abortion (No Birth Defects Reported) | 0 infants |
| First Exposure During Third Trimester | Birth Outcomes by Earliest Pregnancy Trimester of Exposure to Lamotrigine Monotherapy | Spontaneous Pregnancy Loss | 0 infants |
| Unspecified Trimester of Exposure | Birth Outcomes by Earliest Pregnancy Trimester of Exposure to Lamotrigine Monotherapy | Induced Abortion (Birth Defects Reported) | 0 infants |
| Unspecified Trimester of Exposure | Birth Outcomes by Earliest Pregnancy Trimester of Exposure to Lamotrigine Monotherapy | Spontaneous Pregnancy Loss | 0 infants |
| Unspecified Trimester of Exposure | Birth Outcomes by Earliest Pregnancy Trimester of Exposure to Lamotrigine Monotherapy | Induced Abortion (No Birth Defects Reported) | 0 infants |
| Unspecified Trimester of Exposure | Birth Outcomes by Earliest Pregnancy Trimester of Exposure to Lamotrigine Monotherapy | Fetal Death (Birth Defects Reported) | 0 infants |
| Unspecified Trimester of Exposure | Birth Outcomes by Earliest Pregnancy Trimester of Exposure to Lamotrigine Monotherapy | Live Birth (Birth Defects Reported) | 0 infants |
| Unspecified Trimester of Exposure | Birth Outcomes by Earliest Pregnancy Trimester of Exposure to Lamotrigine Monotherapy | Fetal Death (No Birth Defects Reported) | 0 infants |
| Unspecified Trimester of Exposure | Birth Outcomes by Earliest Pregnancy Trimester of Exposure to Lamotrigine Monotherapy | Live Birth (No Birth Defects Reported) | 5 infants |
Primary
Birth Outcomes by Earliest Pregnancy Trimester of Exposure to Lamotrigine Polytherapy Without Valproate
The number of live births, fetal deaths with pregnancy loss occurring \>=20 weeks gestation, induced abortions, and spontaneous pregnancy losses were recorded according to the time at which women were first exposed to lamotrigine polytherapy without valproate. Due to inconsistent identification of major congenital malformations (MCMs) among spontaneous losses, no comment is made concerning the presence or absence of MCMs. Although birth defects may not have been reported, they cannot be ruled out.
Time frame: Although reports and diagnoses of MCMs are accepted up to six years after the birth, the majority of malformations are reported following assessments made in the delivery room or shortly after birth
Population: Prospectively enrolled pregnancies exposed to the lamotrigine polytherapy without valproate
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| First Exposure During First Trimester | Birth Outcomes by Earliest Pregnancy Trimester of Exposure to Lamotrigine Polytherapy Without Valproate | Fetal Death (Birth Defects Reported) | 0 infants |
| First Exposure During First Trimester | Birth Outcomes by Earliest Pregnancy Trimester of Exposure to Lamotrigine Polytherapy Without Valproate | Fetal Death (No Birth Defects Reported) | 3 infants |
| First Exposure During First Trimester | Birth Outcomes by Earliest Pregnancy Trimester of Exposure to Lamotrigine Polytherapy Without Valproate | Live Birth (No Birth Defects Reported) | 418 infants |
| First Exposure During First Trimester | Birth Outcomes by Earliest Pregnancy Trimester of Exposure to Lamotrigine Polytherapy Without Valproate | Live Birth (Birth Defects Reported) | 11 infants |
| First Exposure During First Trimester | Birth Outcomes by Earliest Pregnancy Trimester of Exposure to Lamotrigine Polytherapy Without Valproate | Spontaneous Pregnancy Loss | 22 infants |
| First Exposure During First Trimester | Birth Outcomes by Earliest Pregnancy Trimester of Exposure to Lamotrigine Polytherapy Without Valproate | Induced Abortion (No Birth Defects Reported) | 19 infants |
| First Exposure During First Trimester | Birth Outcomes by Earliest Pregnancy Trimester of Exposure to Lamotrigine Polytherapy Without Valproate | Induced Abortion (Birth Defects Reported) | 1 infants |
| First Exposure During Second Trimester | Birth Outcomes by Earliest Pregnancy Trimester of Exposure to Lamotrigine Polytherapy Without Valproate | Live Birth (No Birth Defects Reported) | 25 infants |
| First Exposure During Second Trimester | Birth Outcomes by Earliest Pregnancy Trimester of Exposure to Lamotrigine Polytherapy Without Valproate | Live Birth (Birth Defects Reported) | 0 infants |
| First Exposure During Second Trimester | Birth Outcomes by Earliest Pregnancy Trimester of Exposure to Lamotrigine Polytherapy Without Valproate | Fetal Death (Birth Defects Reported) | 0 infants |
| First Exposure During Second Trimester | Birth Outcomes by Earliest Pregnancy Trimester of Exposure to Lamotrigine Polytherapy Without Valproate | Induced Abortion (Birth Defects Reported) | 0 infants |
| First Exposure During Second Trimester | Birth Outcomes by Earliest Pregnancy Trimester of Exposure to Lamotrigine Polytherapy Without Valproate | Fetal Death (No Birth Defects Reported) | 0 infants |
| First Exposure During Second Trimester | Birth Outcomes by Earliest Pregnancy Trimester of Exposure to Lamotrigine Polytherapy Without Valproate | Induced Abortion (No Birth Defects Reported) | 0 infants |
| First Exposure During Second Trimester | Birth Outcomes by Earliest Pregnancy Trimester of Exposure to Lamotrigine Polytherapy Without Valproate | Spontaneous Pregnancy Loss | 0 infants |
| First Exposure During Third Trimester | Birth Outcomes by Earliest Pregnancy Trimester of Exposure to Lamotrigine Polytherapy Without Valproate | Fetal Death (No Birth Defects Reported) | 0 infants |
| First Exposure During Third Trimester | Birth Outcomes by Earliest Pregnancy Trimester of Exposure to Lamotrigine Polytherapy Without Valproate | Fetal Death (Birth Defects Reported) | 0 infants |
| First Exposure During Third Trimester | Birth Outcomes by Earliest Pregnancy Trimester of Exposure to Lamotrigine Polytherapy Without Valproate | Spontaneous Pregnancy Loss | 0 infants |
| First Exposure During Third Trimester | Birth Outcomes by Earliest Pregnancy Trimester of Exposure to Lamotrigine Polytherapy Without Valproate | Induced Abortion (No Birth Defects Reported) | 0 infants |
| First Exposure During Third Trimester | Birth Outcomes by Earliest Pregnancy Trimester of Exposure to Lamotrigine Polytherapy Without Valproate | Live Birth (No Birth Defects Reported) | 2 infants |
| First Exposure During Third Trimester | Birth Outcomes by Earliest Pregnancy Trimester of Exposure to Lamotrigine Polytherapy Without Valproate | Induced Abortion (Birth Defects Reported) | 0 infants |
| First Exposure During Third Trimester | Birth Outcomes by Earliest Pregnancy Trimester of Exposure to Lamotrigine Polytherapy Without Valproate | Live Birth (Birth Defects Reported) | 1 infants |
Primary
Birth Outcomes by Earliest Pregnancy Trimester of Exposure to Lamotrigine Polytherapy With Valproate
The number of live births, fetal deaths, induced abortions, and spontaneous pregnancy losses were recorded according to the time at which women were first exposed to lamotrigine polytherapy with valproate. Due to inconsistent identification of major congenital malformations (MCMs) among spontaneous losses, no comment is made concerning the presence or absence of MCMs.
Time frame: Although reports and diagnoses of MCMs are accepted up to six years after the birth, the majority of malformations are reported following assessments made in the delivery room or shortly after birth
Population: Prospectively enrolled pregnancies exposed to lamotrigine polytherapy with valproate.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| First Exposure During First Trimester | Birth Outcomes by Earliest Pregnancy Trimester of Exposure to Lamotrigine Polytherapy With Valproate | Live Birth (Birth Defects Reported) | 14 infants |
| First Exposure During First Trimester | Birth Outcomes by Earliest Pregnancy Trimester of Exposure to Lamotrigine Polytherapy With Valproate | Induced Abortion (No Birth Defects Reported) | 4 infants |
| First Exposure During First Trimester | Birth Outcomes by Earliest Pregnancy Trimester of Exposure to Lamotrigine Polytherapy With Valproate | Fetal Death (No Birth Defects Reported) | 1 infants |
| First Exposure During First Trimester | Birth Outcomes by Earliest Pregnancy Trimester of Exposure to Lamotrigine Polytherapy With Valproate | Fetal Death (Birth Defects Reported) | 0 infants |
| First Exposure During First Trimester | Birth Outcomes by Earliest Pregnancy Trimester of Exposure to Lamotrigine Polytherapy With Valproate | Spontaneous Pregnancy Loss | 6 infants |
| First Exposure During First Trimester | Birth Outcomes by Earliest Pregnancy Trimester of Exposure to Lamotrigine Polytherapy With Valproate | Induced Abortion (Birth Defects Reported) | 2 infants |
| First Exposure During First Trimester | Birth Outcomes by Earliest Pregnancy Trimester of Exposure to Lamotrigine Polytherapy With Valproate | Live Birth (No Birth Defects Reported) | 134 infants |
| First Exposure During Second Trimester | Birth Outcomes by Earliest Pregnancy Trimester of Exposure to Lamotrigine Polytherapy With Valproate | Induced Abortion (No Birth Defects Reported) | 0 infants |
| First Exposure During Second Trimester | Birth Outcomes by Earliest Pregnancy Trimester of Exposure to Lamotrigine Polytherapy With Valproate | Live Birth (No Birth Defects Reported) | 6 infants |
| First Exposure During Second Trimester | Birth Outcomes by Earliest Pregnancy Trimester of Exposure to Lamotrigine Polytherapy With Valproate | Induced Abortion (Birth Defects Reported) | 0 infants |
| First Exposure During Second Trimester | Birth Outcomes by Earliest Pregnancy Trimester of Exposure to Lamotrigine Polytherapy With Valproate | Fetal Death (No Birth Defects Reported) | 1 infants |
| First Exposure During Second Trimester | Birth Outcomes by Earliest Pregnancy Trimester of Exposure to Lamotrigine Polytherapy With Valproate | Spontaneous Pregnancy Loss | 0 infants |
| First Exposure During Second Trimester | Birth Outcomes by Earliest Pregnancy Trimester of Exposure to Lamotrigine Polytherapy With Valproate | Fetal Death (Birth Defects Reported) | 0 infants |
| First Exposure During Second Trimester | Birth Outcomes by Earliest Pregnancy Trimester of Exposure to Lamotrigine Polytherapy With Valproate | Live Birth (Birth Defects Reported) | 1 infants |
| First Exposure During Third Trimester | Birth Outcomes by Earliest Pregnancy Trimester of Exposure to Lamotrigine Polytherapy With Valproate | Live Birth (No Birth Defects Reported) | 3 infants |
| First Exposure During Third Trimester | Birth Outcomes by Earliest Pregnancy Trimester of Exposure to Lamotrigine Polytherapy With Valproate | Live Birth (Birth Defects Reported) | 0 infants |
| First Exposure During Third Trimester | Birth Outcomes by Earliest Pregnancy Trimester of Exposure to Lamotrigine Polytherapy With Valproate | Fetal Death (Birth Defects Reported) | 0 infants |
| First Exposure During Third Trimester | Birth Outcomes by Earliest Pregnancy Trimester of Exposure to Lamotrigine Polytherapy With Valproate | Induced Abortion (Birth Defects Reported) | 0 infants |
| First Exposure During Third Trimester | Birth Outcomes by Earliest Pregnancy Trimester of Exposure to Lamotrigine Polytherapy With Valproate | Fetal Death (No Birth Defects Reported) | 0 infants |
| First Exposure During Third Trimester | Birth Outcomes by Earliest Pregnancy Trimester of Exposure to Lamotrigine Polytherapy With Valproate | Induced Abortion (No Birth Defects Reported) | 0 infants |
| First Exposure During Third Trimester | Birth Outcomes by Earliest Pregnancy Trimester of Exposure to Lamotrigine Polytherapy With Valproate | Spontaneous Pregnancy Loss | 0 infants |
| Unspecified Trimester of Exposure | Birth Outcomes by Earliest Pregnancy Trimester of Exposure to Lamotrigine Polytherapy With Valproate | Induced Abortion (Birth Defects Reported) | 0 infants |
| Unspecified Trimester of Exposure | Birth Outcomes by Earliest Pregnancy Trimester of Exposure to Lamotrigine Polytherapy With Valproate | Spontaneous Pregnancy Loss | 0 infants |
| Unspecified Trimester of Exposure | Birth Outcomes by Earliest Pregnancy Trimester of Exposure to Lamotrigine Polytherapy With Valproate | Induced Abortion (No Birth Defects Reported) | 0 infants |
| Unspecified Trimester of Exposure | Birth Outcomes by Earliest Pregnancy Trimester of Exposure to Lamotrigine Polytherapy With Valproate | Fetal Death (Birth Defects Reported) | 0 infants |
| Unspecified Trimester of Exposure | Birth Outcomes by Earliest Pregnancy Trimester of Exposure to Lamotrigine Polytherapy With Valproate | Live Birth (Birth Defects Reported) | 0 infants |
| Unspecified Trimester of Exposure | Birth Outcomes by Earliest Pregnancy Trimester of Exposure to Lamotrigine Polytherapy With Valproate | Fetal Death (No Birth Defects Reported) | 0 infants |
| Unspecified Trimester of Exposure | Birth Outcomes by Earliest Pregnancy Trimester of Exposure to Lamotrigine Polytherapy With Valproate | Live Birth (No Birth Defects Reported) | 1 infants |
Primary
Number of Infants With Major Congenital Malformations by Earliest Trimester of Exposure to Lamotrigine Monotherapy
Among lamotrigine monotherapy exposures: live births, fetal deaths, induced abortions with birth defects, and live births without defects. Due to the likelihood of inconsistent identification of birth defects among spontaneous losses, fetal deaths, and induced abortions without reported birth defects, these offspring were not included in analyses.
Time frame: Although reports and diagnoses of MCMs are accepted up to six years after the birth, the majority of malformations are reported after assessments made in the delivery room or shortly after birth
Population: Among lamotrigine monotherapy exposures: live births, fetal deaths, induced abortions with birth defects, and live births without defects. Due to the likelihood of inconsistent identification of birth defects among spontaneous losses, fetal deaths, and induced abortions without reported birth defects, these offspring were not included in analyses.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| First Exposure During First Trimester | Number of Infants With Major Congenital Malformations by Earliest Trimester of Exposure to Lamotrigine Monotherapy | 35 infants |
| First Exposure During Second Trimester | Number of Infants With Major Congenital Malformations by Earliest Trimester of Exposure to Lamotrigine Monotherapy | 4 infants |
| First Exposure During Third Trimester | Number of Infants With Major Congenital Malformations by Earliest Trimester of Exposure to Lamotrigine Monotherapy | 1 infants |
| Unspecified Trimester of Exposure | Number of Infants With Major Congenital Malformations by Earliest Trimester of Exposure to Lamotrigine Monotherapy | 0 infants |
| All Trimesters | Number of Infants With Major Congenital Malformations by Earliest Trimester of Exposure to Lamotrigine Monotherapy | 40 infants |
95% CI: [1.6, 3.1]
95% CI: [1.4, 11]
95% CI: [1.7, 3.3]
Primary
Number of Infants With Major Congenital Malformations (MCMs) by Earliest Trimester of Exposure to Lamotrigine Polytherapy Without Valproate
The number of infants with major congenital malformations were counted and are presented by earliest trimester of exposure to lamotrigine polytherapy without valproate.
Time frame: Although reports and diagnoses of MCMs are accepted up to six years after the birth, the majority of malformations are reported following assessments made in the delivery room or shortly after birth
Population: Among lamotrigine polytherapy without valproate exposures: live births, fetal deaths, induced abortions with defects, and live births without defects. Due to the likelihood of inconsistent identification of defects among spontaneous losses, fetal deaths, and induced abortions without reported defects, these offspring were not included in analyses.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| First Exposure During First Trimester | Number of Infants With Major Congenital Malformations (MCMs) by Earliest Trimester of Exposure to Lamotrigine Polytherapy Without Valproate | 12 infants |
| First Exposure During Second Trimester | Number of Infants With Major Congenital Malformations (MCMs) by Earliest Trimester of Exposure to Lamotrigine Polytherapy Without Valproate | 0 infants |
| First Exposure During Third Trimester | Number of Infants With Major Congenital Malformations (MCMs) by Earliest Trimester of Exposure to Lamotrigine Polytherapy Without Valproate | 1 infants |
| All Trimesters | Number of Infants With Major Congenital Malformations (MCMs) by Earliest Trimester of Exposure to Lamotrigine Polytherapy Without Valproate | 13 infants |
95% CI: [1.5, 5]
95% CI: [1.6, 4.9]
Primary
Number of Infants With Major Congenital Malformations (MCMs) by Earliest Trimester of Exposure to Lamotrigine Polytherapy With Valproate
The number of infants with major congenital malformations were counted and are presented by earliest trimester of exposure to lamotrigine polytherapy with valproate.
Time frame: Although reports and diagnoses of MCMs are accepted up to six years after the birth, the majority of malformations are reported following assessments made in the delivery room or shortly after birth
Population: Among lamotrigine polytherapy with valproate exposures: live births, fetal deaths, induced abortions with defects, and live births without defects. Due to the likelihood of inconsistent identification of defects among spontaneous losses, fetal deaths, and induced abortions without reported defects, these offspring were not included in analyses.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| First Exposure During First Trimester | Number of Infants With Major Congenital Malformations (MCMs) by Earliest Trimester of Exposure to Lamotrigine Polytherapy With Valproate | 14 infants |
| First Exposure During Second Trimester | Number of Infants With Major Congenital Malformations (MCMs) by Earliest Trimester of Exposure to Lamotrigine Polytherapy With Valproate | 1 infants |
| First Exposure During Third Trimester | Number of Infants With Major Congenital Malformations (MCMs) by Earliest Trimester of Exposure to Lamotrigine Polytherapy With Valproate | 0 infants |
| Unspecified Trimester of Exposure | Number of Infants With Major Congenital Malformations (MCMs) by Earliest Trimester of Exposure to Lamotrigine Polytherapy With Valproate | 0 infants |
| All Trimesters | Number of Infants With Major Congenital Malformations (MCMs) by Earliest Trimester of Exposure to Lamotrigine Polytherapy With Valproate | 1 infants |
95% CI: [6.4, 17]
95% CI: [5.5, 15.2]
Primary
Number of Infants With the Indicated Major Congenital Malformations Following First Trimester of Exposure to Lamotrigine Polytherapy Without Valproate According to Dose of Lamotrigine Received
The number of infants with the reported MCM following first trimester exposure to lamotrigine polytherapy without valproate were counted.
Time frame: Although reports and diagnoses of MCMs are accepted up to six years after the birth, the majority of malformations are reported after assessments made in the delivery room or shortly after birth
Population: Among lamotrigine polytherapy without valproate exposures in the first trimester: live births, fetal deaths, induced abortions with defects, and live births without defects. Due to the likely inconsistent identification of defects among spontaneous losses, fetal deaths, and induced abortions without reported defects, those offspring were excluded.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| First Exposure During First Trimester | Number of Infants With the Indicated Major Congenital Malformations Following First Trimester of Exposure to Lamotrigine Polytherapy Without Valproate According to Dose of Lamotrigine Received | Neural tube defect | 0 infants |
| First Exposure During First Trimester | Number of Infants With the Indicated Major Congenital Malformations Following First Trimester of Exposure to Lamotrigine Polytherapy Without Valproate According to Dose of Lamotrigine Received | Cardiac septal defect/murmur | 0 infants |
| First Exposure During First Trimester | Number of Infants With the Indicated Major Congenital Malformations Following First Trimester of Exposure to Lamotrigine Polytherapy Without Valproate According to Dose of Lamotrigine Received | Coarctation of aorta | 0 infants |
| First Exposure During First Trimester | Number of Infants With the Indicated Major Congenital Malformations Following First Trimester of Exposure to Lamotrigine Polytherapy Without Valproate According to Dose of Lamotrigine Received | Tetralogy of Fallot | 0 infants |
| First Exposure During First Trimester | Number of Infants With the Indicated Major Congenital Malformations Following First Trimester of Exposure to Lamotrigine Polytherapy Without Valproate According to Dose of Lamotrigine Received | Esophageal defects | 0 infants |
| First Exposure During First Trimester | Number of Infants With the Indicated Major Congenital Malformations Following First Trimester of Exposure to Lamotrigine Polytherapy Without Valproate According to Dose of Lamotrigine Received | Hypospadias | 1 infants |
| First Exposure During First Trimester | Number of Infants With the Indicated Major Congenital Malformations Following First Trimester of Exposure to Lamotrigine Polytherapy Without Valproate According to Dose of Lamotrigine Received | Hydroencephalopathy | 1 infants |
| First Exposure During First Trimester | Number of Infants With the Indicated Major Congenital Malformations Following First Trimester of Exposure to Lamotrigine Polytherapy Without Valproate According to Dose of Lamotrigine Received | Omphalocele | 0 infants |
| First Exposure During First Trimester | Number of Infants With the Indicated Major Congenital Malformations Following First Trimester of Exposure to Lamotrigine Polytherapy Without Valproate According to Dose of Lamotrigine Received | Extra digit | 0 infants |
| First Exposure During First Trimester | Number of Infants With the Indicated Major Congenital Malformations Following First Trimester of Exposure to Lamotrigine Polytherapy Without Valproate According to Dose of Lamotrigine Received | Skin tags on ear | 0 infants |
| First Exposure During Second Trimester | Number of Infants With the Indicated Major Congenital Malformations Following First Trimester of Exposure to Lamotrigine Polytherapy Without Valproate According to Dose of Lamotrigine Received | Extra digit | 0 infants |
| First Exposure During Second Trimester | Number of Infants With the Indicated Major Congenital Malformations Following First Trimester of Exposure to Lamotrigine Polytherapy Without Valproate According to Dose of Lamotrigine Received | Neural tube defect | 0 infants |
| First Exposure During Second Trimester | Number of Infants With the Indicated Major Congenital Malformations Following First Trimester of Exposure to Lamotrigine Polytherapy Without Valproate According to Dose of Lamotrigine Received | Hypospadias | 0 infants |
| First Exposure During Second Trimester | Number of Infants With the Indicated Major Congenital Malformations Following First Trimester of Exposure to Lamotrigine Polytherapy Without Valproate According to Dose of Lamotrigine Received | Esophageal defects | 1 infants |
| First Exposure During Second Trimester | Number of Infants With the Indicated Major Congenital Malformations Following First Trimester of Exposure to Lamotrigine Polytherapy Without Valproate According to Dose of Lamotrigine Received | Cardiac septal defect/murmur | 1 infants |
| First Exposure During Second Trimester | Number of Infants With the Indicated Major Congenital Malformations Following First Trimester of Exposure to Lamotrigine Polytherapy Without Valproate According to Dose of Lamotrigine Received | Skin tags on ear | 0 infants |
| First Exposure During Second Trimester | Number of Infants With the Indicated Major Congenital Malformations Following First Trimester of Exposure to Lamotrigine Polytherapy Without Valproate According to Dose of Lamotrigine Received | Omphalocele | 1 infants |
| First Exposure During Second Trimester | Number of Infants With the Indicated Major Congenital Malformations Following First Trimester of Exposure to Lamotrigine Polytherapy Without Valproate According to Dose of Lamotrigine Received | Coarctation of aorta | 1 infants |
| First Exposure During Second Trimester | Number of Infants With the Indicated Major Congenital Malformations Following First Trimester of Exposure to Lamotrigine Polytherapy Without Valproate According to Dose of Lamotrigine Received | Hydroencephalopathy | 0 infants |
| First Exposure During Second Trimester | Number of Infants With the Indicated Major Congenital Malformations Following First Trimester of Exposure to Lamotrigine Polytherapy Without Valproate According to Dose of Lamotrigine Received | Tetralogy of Fallot | 0 infants |
| First Exposure During Third Trimester | Number of Infants With the Indicated Major Congenital Malformations Following First Trimester of Exposure to Lamotrigine Polytherapy Without Valproate According to Dose of Lamotrigine Received | Omphalocele | 0 infants |
| First Exposure During Third Trimester | Number of Infants With the Indicated Major Congenital Malformations Following First Trimester of Exposure to Lamotrigine Polytherapy Without Valproate According to Dose of Lamotrigine Received | Tetralogy of Fallot | 1 infants |
| First Exposure During Third Trimester | Number of Infants With the Indicated Major Congenital Malformations Following First Trimester of Exposure to Lamotrigine Polytherapy Without Valproate According to Dose of Lamotrigine Received | Esophageal defects | 1 infants |
| First Exposure During Third Trimester | Number of Infants With the Indicated Major Congenital Malformations Following First Trimester of Exposure to Lamotrigine Polytherapy Without Valproate According to Dose of Lamotrigine Received | Hypospadias | 0 infants |
| First Exposure During Third Trimester | Number of Infants With the Indicated Major Congenital Malformations Following First Trimester of Exposure to Lamotrigine Polytherapy Without Valproate According to Dose of Lamotrigine Received | Extra digit | 1 infants |
| First Exposure During Third Trimester | Number of Infants With the Indicated Major Congenital Malformations Following First Trimester of Exposure to Lamotrigine Polytherapy Without Valproate According to Dose of Lamotrigine Received | Hydroencephalopathy | 0 infants |
| First Exposure During Third Trimester | Number of Infants With the Indicated Major Congenital Malformations Following First Trimester of Exposure to Lamotrigine Polytherapy Without Valproate According to Dose of Lamotrigine Received | Neural tube defect | 1 infants |
| First Exposure During Third Trimester | Number of Infants With the Indicated Major Congenital Malformations Following First Trimester of Exposure to Lamotrigine Polytherapy Without Valproate According to Dose of Lamotrigine Received | Skin tags on ear | 1 infants |
| First Exposure During Third Trimester | Number of Infants With the Indicated Major Congenital Malformations Following First Trimester of Exposure to Lamotrigine Polytherapy Without Valproate According to Dose of Lamotrigine Received | Cardiac septal defect/murmur | 1 infants |
| First Exposure During Third Trimester | Number of Infants With the Indicated Major Congenital Malformations Following First Trimester of Exposure to Lamotrigine Polytherapy Without Valproate According to Dose of Lamotrigine Received | Coarctation of aorta | 0 infants |
Primary
Number of Infants With the Indicated Major Congenital Malformations Following First Trimester of Exposure to Lamotrigine Polytherapy With Valproate According to Dose of Lamotrigine Received
The number of infants with the reported MCM following first trimester exposure to lamotrigine polytherapy with valproate were counted.
Time frame: Although reports and diagnoses of MCMs are accepted up to six years after the birth, the majority of malformations are reported after assessments made in the delivery room or shortly after birth
Population: Among lamotrigine polytherapy with valproate exposures in the first trimester: live births, fetal deaths, induced abortions with defects, and live births without defects. Due to the likely inconsistent identification of defects among spontaneous losses, fetal deaths, and induced abortions without reported defects, those offspring were excluded.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| First Exposure During First Trimester | Number of Infants With the Indicated Major Congenital Malformations Following First Trimester of Exposure to Lamotrigine Polytherapy With Valproate According to Dose of Lamotrigine Received | Hydrocephalus/spina bifida | 1 infants |
| First Exposure During First Trimester | Number of Infants With the Indicated Major Congenital Malformations Following First Trimester of Exposure to Lamotrigine Polytherapy With Valproate According to Dose of Lamotrigine Received | Meningomyelocele | 1 infants |
| First Exposure During First Trimester | Number of Infants With the Indicated Major Congenital Malformations Following First Trimester of Exposure to Lamotrigine Polytherapy With Valproate According to Dose of Lamotrigine Received | Microcephaly | 1 infants |
| First Exposure During First Trimester | Number of Infants With the Indicated Major Congenital Malformations Following First Trimester of Exposure to Lamotrigine Polytherapy With Valproate According to Dose of Lamotrigine Received | Orofacial clefts | 2 infants |
| First Exposure During First Trimester | Number of Infants With the Indicated Major Congenital Malformations Following First Trimester of Exposure to Lamotrigine Polytherapy With Valproate According to Dose of Lamotrigine Received | Cardiac septal defects | 0 infants |
| First Exposure During First Trimester | Number of Infants With the Indicated Major Congenital Malformations Following First Trimester of Exposure to Lamotrigine Polytherapy With Valproate According to Dose of Lamotrigine Received | Transposition of great vessels | 1 infants |
| First Exposure During First Trimester | Number of Infants With the Indicated Major Congenital Malformations Following First Trimester of Exposure to Lamotrigine Polytherapy With Valproate According to Dose of Lamotrigine Received | Ventricular hypoplasia | 1 infants |
| First Exposure During First Trimester | Number of Infants With the Indicated Major Congenital Malformations Following First Trimester of Exposure to Lamotrigine Polytherapy With Valproate According to Dose of Lamotrigine Received | Pulmonary stenosis | 1 infants |
| First Exposure During First Trimester | Number of Infants With the Indicated Major Congenital Malformations Following First Trimester of Exposure to Lamotrigine Polytherapy With Valproate According to Dose of Lamotrigine Received | Pyloric stenosis | 1 infants |
| First Exposure During First Trimester | Number of Infants With the Indicated Major Congenital Malformations Following First Trimester of Exposure to Lamotrigine Polytherapy With Valproate According to Dose of Lamotrigine Received | Gastroschisis | 1 infants |
| First Exposure During First Trimester | Number of Infants With the Indicated Major Congenital Malformations Following First Trimester of Exposure to Lamotrigine Polytherapy With Valproate According to Dose of Lamotrigine Received | Club foot | 2 infants |
| First Exposure During First Trimester | Number of Infants With the Indicated Major Congenital Malformations Following First Trimester of Exposure to Lamotrigine Polytherapy With Valproate According to Dose of Lamotrigine Received | Polydactyly | 1 infants |
| First Exposure During Second Trimester | Number of Infants With the Indicated Major Congenital Malformations Following First Trimester of Exposure to Lamotrigine Polytherapy With Valproate According to Dose of Lamotrigine Received | Club foot | 0 infants |
| First Exposure During Second Trimester | Number of Infants With the Indicated Major Congenital Malformations Following First Trimester of Exposure to Lamotrigine Polytherapy With Valproate According to Dose of Lamotrigine Received | Hydrocephalus/spina bifida | 0 infants |
| First Exposure During Second Trimester | Number of Infants With the Indicated Major Congenital Malformations Following First Trimester of Exposure to Lamotrigine Polytherapy With Valproate According to Dose of Lamotrigine Received | Ventricular hypoplasia | 0 infants |
| First Exposure During Second Trimester | Number of Infants With the Indicated Major Congenital Malformations Following First Trimester of Exposure to Lamotrigine Polytherapy With Valproate According to Dose of Lamotrigine Received | Meningomyelocele | 0 infants |
| First Exposure During Second Trimester | Number of Infants With the Indicated Major Congenital Malformations Following First Trimester of Exposure to Lamotrigine Polytherapy With Valproate According to Dose of Lamotrigine Received | Gastroschisis | 0 infants |
| First Exposure During Second Trimester | Number of Infants With the Indicated Major Congenital Malformations Following First Trimester of Exposure to Lamotrigine Polytherapy With Valproate According to Dose of Lamotrigine Received | Microcephaly | 0 infants |
| First Exposure During Second Trimester | Number of Infants With the Indicated Major Congenital Malformations Following First Trimester of Exposure to Lamotrigine Polytherapy With Valproate According to Dose of Lamotrigine Received | Pulmonary stenosis | 0 infants |
| First Exposure During Second Trimester | Number of Infants With the Indicated Major Congenital Malformations Following First Trimester of Exposure to Lamotrigine Polytherapy With Valproate According to Dose of Lamotrigine Received | Orofacial clefts | 1 infants |
| First Exposure During Second Trimester | Number of Infants With the Indicated Major Congenital Malformations Following First Trimester of Exposure to Lamotrigine Polytherapy With Valproate According to Dose of Lamotrigine Received | Polydactyly | 0 infants |
| First Exposure During Second Trimester | Number of Infants With the Indicated Major Congenital Malformations Following First Trimester of Exposure to Lamotrigine Polytherapy With Valproate According to Dose of Lamotrigine Received | Cardiac septal defects | 2 infants |
| First Exposure During Second Trimester | Number of Infants With the Indicated Major Congenital Malformations Following First Trimester of Exposure to Lamotrigine Polytherapy With Valproate According to Dose of Lamotrigine Received | Pyloric stenosis | 0 infants |
| First Exposure During Second Trimester | Number of Infants With the Indicated Major Congenital Malformations Following First Trimester of Exposure to Lamotrigine Polytherapy With Valproate According to Dose of Lamotrigine Received | Transposition of great vessels | 0 infants |
Primary
Number of Infants With the Indicated Major Congenital Malformations Following the First Trimester of Exposure to Lamotrigine Monotherapy According to Dose Received
The number of infants with the reported MCM following first trimester lamotrigine monotherapy exposure were counted. Registry personnel contacted the enrolling physician to obtain information on the pregnancy outcome, lamotrigine dosing and duration of exposure, and use of concomitant antiepileptic drugs during pregnancy.
Time frame: Although reports and diagnoses of MCMs are accepted up to six years after the birth, the majority of malformations are reported after assessments made in the delivery room or shortly after birth
Population: Among lamotrigine monotherapy exposures in the first trimester: live births, fetal deaths, induced abortions with defects, and live births without defects. Due to the likely inconsistent identification of defects among spontaneous losses, fetal deaths, and induced abortions without reported defects, these offspring were not included in analyses.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| First Exposure During First Trimester | Number of Infants With the Indicated Major Congenital Malformations Following the First Trimester of Exposure to Lamotrigine Monotherapy According to Dose Received | Anencephaly | 2 infants |
| First Exposure During First Trimester | Number of Infants With the Indicated Major Congenital Malformations Following the First Trimester of Exposure to Lamotrigine Monotherapy According to Dose Received | Minor heart defect, unspecified | 0 infants |
| First Exposure During First Trimester | Number of Infants With the Indicated Major Congenital Malformations Following the First Trimester of Exposure to Lamotrigine Monotherapy According to Dose Received | Diaphragmatic hernia | 1 infants |
| First Exposure During First Trimester | Number of Infants With the Indicated Major Congenital Malformations Following the First Trimester of Exposure to Lamotrigine Monotherapy According to Dose Received | Pyloric stenosis | 0 infants |
| First Exposure During First Trimester | Number of Infants With the Indicated Major Congenital Malformations Following the First Trimester of Exposure to Lamotrigine Monotherapy According to Dose Received | Hypospadias | 1 infants |
| First Exposure During First Trimester | Number of Infants With the Indicated Major Congenital Malformations Following the First Trimester of Exposure to Lamotrigine Monotherapy According to Dose Received | Pulmonary stenosis | 0 infants |
| First Exposure During First Trimester | Number of Infants With the Indicated Major Congenital Malformations Following the First Trimester of Exposure to Lamotrigine Monotherapy According to Dose Received | Congenital atresia of anus | 1 infants |
| First Exposure During First Trimester | Number of Infants With the Indicated Major Congenital Malformations Following the First Trimester of Exposure to Lamotrigine Monotherapy According to Dose Received | Light spot across entire abdomen | 0 infants |
| First Exposure During First Trimester | Number of Infants With the Indicated Major Congenital Malformations Following the First Trimester of Exposure to Lamotrigine Monotherapy According to Dose Received | Polydactyly | 1 infants |
| First Exposure During First Trimester | Number of Infants With the Indicated Major Congenital Malformations Following the First Trimester of Exposure to Lamotrigine Monotherapy According to Dose Received | Hydronephrosis | 1 infants |
| First Exposure During First Trimester | Number of Infants With the Indicated Major Congenital Malformations Following the First Trimester of Exposure to Lamotrigine Monotherapy According to Dose Received | Orofacial clefts | 2 infants |
| First Exposure During First Trimester | Number of Infants With the Indicated Major Congenital Malformations Following the First Trimester of Exposure to Lamotrigine Monotherapy According to Dose Received | Hypoplastic left heart/left ventricle hypoplasia | 1 infants |
| First Exposure During First Trimester | Number of Infants With the Indicated Major Congenital Malformations Following the First Trimester of Exposure to Lamotrigine Monotherapy According to Dose Received | Epidermolysis bullosa | 1 infants |
| First Exposure During First Trimester | Number of Infants With the Indicated Major Congenital Malformations Following the First Trimester of Exposure to Lamotrigine Monotherapy According to Dose Received | Renal defect (absent, polysystic, fluid on kidney) | 1 infants |
| First Exposure During First Trimester | Number of Infants With the Indicated Major Congenital Malformations Following the First Trimester of Exposure to Lamotrigine Monotherapy According to Dose Received | Ventricular septal defects | 0 infants |
| First Exposure During First Trimester | Number of Infants With the Indicated Major Congenital Malformations Following the First Trimester of Exposure to Lamotrigine Monotherapy According to Dose Received | Transposition of great vessels | 2 infants |
| First Exposure During First Trimester | Number of Infants With the Indicated Major Congenital Malformations Following the First Trimester of Exposure to Lamotrigine Monotherapy According to Dose Received | Club feet | 0 infants |
| First Exposure During First Trimester | Number of Infants With the Indicated Major Congenital Malformations Following the First Trimester of Exposure to Lamotrigine Monotherapy According to Dose Received | Cortical dysplasis | 0 infants |
| First Exposure During First Trimester | Number of Infants With the Indicated Major Congenital Malformations Following the First Trimester of Exposure to Lamotrigine Monotherapy According to Dose Received | Hip dislocation | 1 infants |
| First Exposure During Second Trimester | Number of Infants With the Indicated Major Congenital Malformations Following the First Trimester of Exposure to Lamotrigine Monotherapy According to Dose Received | Cortical dysplasis | 1 infants |
| First Exposure During Second Trimester | Number of Infants With the Indicated Major Congenital Malformations Following the First Trimester of Exposure to Lamotrigine Monotherapy According to Dose Received | Hip dislocation | 0 infants |
| First Exposure During Second Trimester | Number of Infants With the Indicated Major Congenital Malformations Following the First Trimester of Exposure to Lamotrigine Monotherapy According to Dose Received | Hypospadias | 1 infants |
| First Exposure During Second Trimester | Number of Infants With the Indicated Major Congenital Malformations Following the First Trimester of Exposure to Lamotrigine Monotherapy According to Dose Received | Epidermolysis bullosa | 0 infants |
| First Exposure During Second Trimester | Number of Infants With the Indicated Major Congenital Malformations Following the First Trimester of Exposure to Lamotrigine Monotherapy According to Dose Received | Pyloric stenosis | 1 infants |
| First Exposure During Second Trimester | Number of Infants With the Indicated Major Congenital Malformations Following the First Trimester of Exposure to Lamotrigine Monotherapy According to Dose Received | Congenital atresia of anus | 0 infants |
| First Exposure During Second Trimester | Number of Infants With the Indicated Major Congenital Malformations Following the First Trimester of Exposure to Lamotrigine Monotherapy According to Dose Received | Diaphragmatic hernia | 0 infants |
| First Exposure During Second Trimester | Number of Infants With the Indicated Major Congenital Malformations Following the First Trimester of Exposure to Lamotrigine Monotherapy According to Dose Received | Transposition of great vessels | 0 infants |
| First Exposure During Second Trimester | Number of Infants With the Indicated Major Congenital Malformations Following the First Trimester of Exposure to Lamotrigine Monotherapy According to Dose Received | Ventricular septal defects | 3 infants |
| First Exposure During Second Trimester | Number of Infants With the Indicated Major Congenital Malformations Following the First Trimester of Exposure to Lamotrigine Monotherapy According to Dose Received | Orofacial clefts | 0 infants |
| First Exposure During Second Trimester | Number of Infants With the Indicated Major Congenital Malformations Following the First Trimester of Exposure to Lamotrigine Monotherapy According to Dose Received | Minor heart defect, unspecified | 1 infants |
| First Exposure During Second Trimester | Number of Infants With the Indicated Major Congenital Malformations Following the First Trimester of Exposure to Lamotrigine Monotherapy According to Dose Received | Anencephaly | 0 infants |
| First Exposure During Second Trimester | Number of Infants With the Indicated Major Congenital Malformations Following the First Trimester of Exposure to Lamotrigine Monotherapy According to Dose Received | Polydactyly | 1 infants |
| First Exposure During Second Trimester | Number of Infants With the Indicated Major Congenital Malformations Following the First Trimester of Exposure to Lamotrigine Monotherapy According to Dose Received | Pulmonary stenosis | 1 infants |
| First Exposure During Second Trimester | Number of Infants With the Indicated Major Congenital Malformations Following the First Trimester of Exposure to Lamotrigine Monotherapy According to Dose Received | Hydronephrosis | 1 infants |
| First Exposure During Second Trimester | Number of Infants With the Indicated Major Congenital Malformations Following the First Trimester of Exposure to Lamotrigine Monotherapy According to Dose Received | Club feet | 1 infants |
| First Exposure During Second Trimester | Number of Infants With the Indicated Major Congenital Malformations Following the First Trimester of Exposure to Lamotrigine Monotherapy According to Dose Received | Renal defect (absent, polysystic, fluid on kidney) | 0 infants |
| First Exposure During Second Trimester | Number of Infants With the Indicated Major Congenital Malformations Following the First Trimester of Exposure to Lamotrigine Monotherapy According to Dose Received | Hypoplastic left heart/left ventricle hypoplasia | 0 infants |
| First Exposure During Second Trimester | Number of Infants With the Indicated Major Congenital Malformations Following the First Trimester of Exposure to Lamotrigine Monotherapy According to Dose Received | Light spot across entire abdomen | 1 infants |
| First Exposure During Third Trimester | Number of Infants With the Indicated Major Congenital Malformations Following the First Trimester of Exposure to Lamotrigine Monotherapy According to Dose Received | Polydactyly | 0 infants |
| First Exposure During Third Trimester | Number of Infants With the Indicated Major Congenital Malformations Following the First Trimester of Exposure to Lamotrigine Monotherapy According to Dose Received | Anencephaly | 1 infants |
| First Exposure During Third Trimester | Number of Infants With the Indicated Major Congenital Malformations Following the First Trimester of Exposure to Lamotrigine Monotherapy According to Dose Received | Orofacial clefts | 0 infants |
| First Exposure During Third Trimester | Number of Infants With the Indicated Major Congenital Malformations Following the First Trimester of Exposure to Lamotrigine Monotherapy According to Dose Received | Hypoplastic left heart/left ventricle hypoplasia | 1 infants |
| First Exposure During Third Trimester | Number of Infants With the Indicated Major Congenital Malformations Following the First Trimester of Exposure to Lamotrigine Monotherapy According to Dose Received | Transposition of great vessels | 0 infants |
| First Exposure During Third Trimester | Number of Infants With the Indicated Major Congenital Malformations Following the First Trimester of Exposure to Lamotrigine Monotherapy According to Dose Received | Ventricular septal defects | 0 infants |
| First Exposure During Third Trimester | Number of Infants With the Indicated Major Congenital Malformations Following the First Trimester of Exposure to Lamotrigine Monotherapy According to Dose Received | Minor heart defect, unspecified | 0 infants |
| First Exposure During Third Trimester | Number of Infants With the Indicated Major Congenital Malformations Following the First Trimester of Exposure to Lamotrigine Monotherapy According to Dose Received | Pulmonary stenosis | 0 infants |
| First Exposure During Third Trimester | Number of Infants With the Indicated Major Congenital Malformations Following the First Trimester of Exposure to Lamotrigine Monotherapy According to Dose Received | Hydronephrosis | 0 infants |
| First Exposure During Third Trimester | Number of Infants With the Indicated Major Congenital Malformations Following the First Trimester of Exposure to Lamotrigine Monotherapy According to Dose Received | Renal defect (absent, polysystic, fluid on kidney) | 2 infants |
| First Exposure During Third Trimester | Number of Infants With the Indicated Major Congenital Malformations Following the First Trimester of Exposure to Lamotrigine Monotherapy According to Dose Received | Cortical dysplasis | 0 infants |
| First Exposure During Third Trimester | Number of Infants With the Indicated Major Congenital Malformations Following the First Trimester of Exposure to Lamotrigine Monotherapy According to Dose Received | Hypospadias | 0 infants |
| First Exposure During Third Trimester | Number of Infants With the Indicated Major Congenital Malformations Following the First Trimester of Exposure to Lamotrigine Monotherapy According to Dose Received | Pyloric stenosis | 0 infants |
| First Exposure During Third Trimester | Number of Infants With the Indicated Major Congenital Malformations Following the First Trimester of Exposure to Lamotrigine Monotherapy According to Dose Received | Diaphragmatic hernia | 1 infants |
| First Exposure During Third Trimester | Number of Infants With the Indicated Major Congenital Malformations Following the First Trimester of Exposure to Lamotrigine Monotherapy According to Dose Received | Congenital atresia of anus | 0 infants |
| First Exposure During Third Trimester | Number of Infants With the Indicated Major Congenital Malformations Following the First Trimester of Exposure to Lamotrigine Monotherapy According to Dose Received | Hip dislocation | 0 infants |
| First Exposure During Third Trimester | Number of Infants With the Indicated Major Congenital Malformations Following the First Trimester of Exposure to Lamotrigine Monotherapy According to Dose Received | Club feet | 1 infants |
| First Exposure During Third Trimester | Number of Infants With the Indicated Major Congenital Malformations Following the First Trimester of Exposure to Lamotrigine Monotherapy According to Dose Received | Epidermolysis bullosa | 0 infants |
| First Exposure During Third Trimester | Number of Infants With the Indicated Major Congenital Malformations Following the First Trimester of Exposure to Lamotrigine Monotherapy According to Dose Received | Light spot across entire abdomen | 0 infants |
| Unspecified Trimester of Exposure | Number of Infants With the Indicated Major Congenital Malformations Following the First Trimester of Exposure to Lamotrigine Monotherapy According to Dose Received | Cortical dysplasis | 0 infants |
| Unspecified Trimester of Exposure | Number of Infants With the Indicated Major Congenital Malformations Following the First Trimester of Exposure to Lamotrigine Monotherapy According to Dose Received | Orofacial clefts | 0 infants |
| Unspecified Trimester of Exposure | Number of Infants With the Indicated Major Congenital Malformations Following the First Trimester of Exposure to Lamotrigine Monotherapy According to Dose Received | Hip dislocation | 0 infants |
| Unspecified Trimester of Exposure | Number of Infants With the Indicated Major Congenital Malformations Following the First Trimester of Exposure to Lamotrigine Monotherapy According to Dose Received | Renal defect (absent, polysystic, fluid on kidney) | 0 infants |
| Unspecified Trimester of Exposure | Number of Infants With the Indicated Major Congenital Malformations Following the First Trimester of Exposure to Lamotrigine Monotherapy According to Dose Received | Hydronephrosis | 0 infants |
| Unspecified Trimester of Exposure | Number of Infants With the Indicated Major Congenital Malformations Following the First Trimester of Exposure to Lamotrigine Monotherapy According to Dose Received | Anencephaly | 0 infants |
| Unspecified Trimester of Exposure | Number of Infants With the Indicated Major Congenital Malformations Following the First Trimester of Exposure to Lamotrigine Monotherapy According to Dose Received | Club feet | 1 infants |
| Unspecified Trimester of Exposure | Number of Infants With the Indicated Major Congenital Malformations Following the First Trimester of Exposure to Lamotrigine Monotherapy According to Dose Received | Pulmonary stenosis | 0 infants |
| Unspecified Trimester of Exposure | Number of Infants With the Indicated Major Congenital Malformations Following the First Trimester of Exposure to Lamotrigine Monotherapy According to Dose Received | Minor heart defect, unspecified | 0 infants |
| Unspecified Trimester of Exposure | Number of Infants With the Indicated Major Congenital Malformations Following the First Trimester of Exposure to Lamotrigine Monotherapy According to Dose Received | Ventricular septal defects | 0 infants |
| Unspecified Trimester of Exposure | Number of Infants With the Indicated Major Congenital Malformations Following the First Trimester of Exposure to Lamotrigine Monotherapy According to Dose Received | Polydactyly | 0 infants |
| Unspecified Trimester of Exposure | Number of Infants With the Indicated Major Congenital Malformations Following the First Trimester of Exposure to Lamotrigine Monotherapy According to Dose Received | Transposition of great vessels | 0 infants |
| Unspecified Trimester of Exposure | Number of Infants With the Indicated Major Congenital Malformations Following the First Trimester of Exposure to Lamotrigine Monotherapy According to Dose Received | Hypoplastic left heart/left ventricle hypoplasia | 0 infants |
| Unspecified Trimester of Exposure | Number of Infants With the Indicated Major Congenital Malformations Following the First Trimester of Exposure to Lamotrigine Monotherapy According to Dose Received | Light spot across entire abdomen | 0 infants |
| Unspecified Trimester of Exposure | Number of Infants With the Indicated Major Congenital Malformations Following the First Trimester of Exposure to Lamotrigine Monotherapy According to Dose Received | Diaphragmatic hernia | 0 infants |
| Unspecified Trimester of Exposure | Number of Infants With the Indicated Major Congenital Malformations Following the First Trimester of Exposure to Lamotrigine Monotherapy According to Dose Received | Pyloric stenosis | 1 infants |
| Unspecified Trimester of Exposure | Number of Infants With the Indicated Major Congenital Malformations Following the First Trimester of Exposure to Lamotrigine Monotherapy According to Dose Received | Epidermolysis bullosa | 0 infants |
| Unspecified Trimester of Exposure | Number of Infants With the Indicated Major Congenital Malformations Following the First Trimester of Exposure to Lamotrigine Monotherapy According to Dose Received | Congenital atresia of anus | 0 infants |
| Unspecified Trimester of Exposure | Number of Infants With the Indicated Major Congenital Malformations Following the First Trimester of Exposure to Lamotrigine Monotherapy According to Dose Received | Hypospadias | 0 infants |