Pregnant Women, Psychotropic Drugs
Conditions
Keywords
Pregnancy, Medication use during pregnancy, Psychiatric medications, ADHD, Atypical Antipsychotics, Antidepressants, Sedative Hypnotics
Brief summary
The National Pregnancy Registry for Psychiatric Medications is dedicated to evaluating the safety of psychiatric medications such as antidepressants, ADHD medications, sedative hypnotics, and atypical antipsychotics that many people take during pregnancy to treat a wide range of mood, anxiety, executive function, or psychiatric disorders. The goal of this Registry is to gather information on the safety of these medications during pregnancy, as current data is limited.
Detailed description
The overarching objectives of the National Pregnancy Registry for Psychiatric Medications are twofold: to assess risk for malformations among infants exposed to specific psychiatric medications and to assess neonatal outcomes associated with prenatal exposure to such medication. Specifically, the Registry will allow us to prospectively determine whether exposure to psychiatric medication is associated with any increased risk for major malformations above the baseline risk noted in the general population. This will be achieved by careful systematic documentation of medication exposure during pregnancy, as well as other relevant exposures often not included in small case series or published reviews of drug safety derived from large administrative databases. Although psychiatric medications are widely used by reproductive age women, reliable data regarding the reproductive safety of many of these compounds is limited. As a result, clinicians often lack sufficient evidence to evaluate the risks and benefits of using medications to treat psychiatric disorders during pregnancy. The National Pregnancy Registry for Psychiatric Medications is one of the first, and largest, hospital-based pregnancy registries which will systematically and prospectively monitor pregnancy outcomes after exposure to psychiatric medications, including antidepressants, ADHD medications, sedative hypnotics, and atypical antipsychotics. Primary Aim: To prospectively evaluate rates of congenital malformations among infants exposed in-utero to psychiatric medications. Secondary Aims: 1. To evaluate neonatal outcomes of infants with prenatal exposure to specific psychiatric medications alone or in combination with other psychotropics. 2. To evaluate maternal health outcomes associated with use of psychiatric medications during pregnancy. 3. To evaluate neurobehavioral development of children (1 month and older) with prenatal exposure to psychiatric medications.
Interventions
None listed
Sponsors
Alkermes, Inc.
Eisai Inc.
Otsuka America Pharmaceutical
Supernus Pharmaceuticals, Inc.
Sage Therapeutics
Bristol-Myers Squibb
Massachusetts General Hospital
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Pregnant women * Age 18-45 * Subjects will be willing to participate over the phone * Subjects will be able to provide informed consent
Exclusion criteria
* Women who have completed their pregnancy * Women who are planning to become pregnant * Women who are not taking any psychiatric medications and/or have no history of psychiatric illness
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Major Malformations in Infants | Birth up to 1 year; assessed at 8-12 weeks postpartum, assessed through medical records through 1 year of age. | The primary outcome for this study is rates of major malformations among infants exposed in-utero to psychiatric medications. A major malformation is defined as a structural abnormality with surgical, medical, or cosmetic importance. Exclusions include (1) minor anomalies; (2) deformations; (3) physiologic features due to prematurity, such as undescended testes; (4) birthmarks; (5) genetic disorders and chromosomal abnormalities; and (6) any finding by prenatal sonography, such as absence of 1 kidney, or at surgery (or autopsy) that was not identified by an examining pediatrician. This data is collected through review of pediatric medical records through the first twelve months of infants' lives. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Preeclampsia/Eclampsia | Any time during pregnancy; assessed at baseline, 7 months' gestation and 8-12 weeks postpartum. | Pre-eclampsia or eclampsia diagnosed during pregnancy, assessed as a yes/no outcome. |
| Maternal Gestational Weight Gain | Change from pre-pregnancy to delivery; assessed at 7 months' gestation and 8-12 weeks postpartum. | Maternal gestational weight gain is measured by the change in maternal weight from pre-pregnancy to weight at delivery, recorded in pounds. |
| Live Birth | Birth; assessed at 8-12 weeks postpartum. | Did the pregnancy end in a live birth, assessed as a yes/no outcome. |
| Spontaneous Abortion (SAB) | Any time during pregnancy; assessed at 7 months' gestation and 8-12 weeks postpartum. | Did a spontaneous abortion (SAB) occur during the pregnancy, assessed as a yes/no outcome. |
| Intrauterine Fetal Demise (IUFD) | Any time during pregnancy; assessed at 7 months' gestation and 8-12 weeks postpartum. | Did intrauterine fetal demise (IUFD) occur during the pregnancy, assessed as a yes/no outcome. |
| Gestational Age | Birth; assessed at 8-12 weeks postpartum. | The gestational age of the infant at birth, recorded in weeks and days. |
| Preterm Delivery | Any time during pregnancy; assessed at 7 months' gestation and 8-12 weeks postpartum. | Was the baby born before 37 weeks gestational age, assessed as a yes/no outcome. |
| Birth Weight | Birth; assessed at 8-12 weeks postpartum. | Birth weight of the infant, recorded in grams or lbs and oz |
| Delivery Method | Birth; assessed at 8-12 weeks postpartum. | Was birth vaginal or by C-section; if C-section, emergent: yes/no |
| Apgar Scores | Birth; assessed at 8-12 weeks postpartum. | 1-min and 5-min Apgar scores. |
| Gestational Hypertension | Any time during pregnancy; assessed at baseline, 7 months' gestation and 8-12 weeks postpartum. | Gestational hypertension diagnosed during pregnancy, assessed as a yes/no outcome. |
| Maternal Postpartum Hemorrhage | Birth; assessed at 8-12 weeks postpartum. | Did maternal postpartum hemorrhage occur, assessed as a yes/no outcome. |
| Neonatal Intensive Care Unit (NICU) admission | Birth up to 1 year; assessed at 8-12 weeks postpartum, assessed through medical records through 1 year of age. | Was the infant admitted to the NICU, assessed as a yes/no outcome; if yes, number of days in NICU and reason for admission |
| Infant Death | Birth up to 1 year; assessed at 8-12 weeks postpartum, assessed through medical records through 1 year of age. | Did the infant die before the age of one; assessed as a yes/no outcome. |
| Neonatal Extrapyramidal Symptoms | Birth through 1 year; assessed at 8-12 weeks postpartum, assessed through medical records through 1 year of age. | Did movement dysfunction occur in the infant (such as dystonia, akathisia, parkinsonism characteristic symptoms such as rigidity, bradykinesia, tremor, and tardive dyskinesia); assessed as a yes/no outcome. |
| Poor Neonatal Adaptation Syndrome (PNAS) | Birth through 1 year; assessed at 8-12 weeks postpartum, assessed through medical records through 1 year of age. | Did poor neonatal adaptation syndrome (PNAS) occur (including poor muscle tone, tremors, jitteriness, irritability, seizures, feeding difficulties, sleep disturbances, hypoglycemia, and respiratory distress); assessed as a yes/no outcome |
| Child Development Outcomes - Ages and Stages Questionnaire (ASQ-3) | Assessed at 9 months, year 3, and year 5. | Were there developmental concerns, as assessed by the Ages and Stages Questionnaire (ASQ-3). |
| Child Development Outcomes - Preschool Child Behavior Checklist (CBCL) | Assessed at 9 months, year 3, and year 5. | Were there developmental concerns, as assessed by the Preschool Child Behavior Checklist (CBCL). |
| Breastfeeding | Assessed at 8-12 weeks postpartum. | Did breastfeeding occur, assessed as a yes/no outcome; if yes, duration of breastfeeding recorded in weeks. |
| Gestational Diabetes | Any time during pregnancy; assessed at baseline, 7 months' gestation and 8-12 weeks postpartum. | Gestational diabetes diagnosed during pregnancy, assessed as a yes/no outcome. |
Countries
United States
Contacts
Primary ContactBryn Rediger
Backup ContactLee Cohen, MD
Outcome results
None listed