Hypothyroidism, Pregnancy
Conditions
Keywords
pregnancy, hypothyroidism, levothyroxine
Brief summary
Our aim is to compare the safety and efficacy of 2 different empiric levothyroxine dose adjustment recommendations to be made at the first confirmation of pregnancy in women with a history of hypothyroidism. Subjects will be women with a prior diagnosis of hypothyroidism who are taking thyroid hormone replacement and who are less than 8 weeks pregnant. Upon confirmation of pregnancy, subjects will be randomized to increase their weekly thyroid hormone dose by either 2 or 3 tablets (28 or 42%). Thyroid function will be evaluated every two weeks in the first 20 weeks and then again at week 30 and post-partum. Primary endpoints will be the proportion of women in each group who remain euthyroid throughout the first trimester and throughout pregnancy.
Detailed description
Our aim is to compare the safety and efficacy of 2 different empiric levothyroxine dose adjustment recommendations to be made at the first confirmation of pregnancy in women with a history of hypothyroidism. Subjects will be women with a prior diagnosis of hypothyroidism who are taking thyroid hormone replacement and who are less than 8 weeks pregnant. Upon confirmation of pregnancy, subjects will be randomized to increase their weekly thyroid hormone dose by either 2 or 3 tablets (28 or 42%). Thyroid function will be evaluated every two weeks in the first 20 weeks and then again at week 30 and post-partum. Primary endpoints will be the proportion of women in each group who remain euthyroid throughout the first trimester and throughout pregnancy
Interventions
DRUGAnticipatory dose increase of levothyroxine
as it is know that levothyroxine requirement increases in pregnancy, both study arms will increase levothyroxine dose, though by different amounts.
DRUGlevothyroxine
patients will increase levothyroxine dosage by 2 extra tablets of their current dose per week
Sponsors
Harvard Medical School (HMS and HSDM)
Brigham and Women's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
No
Inclusion criteria
* women with a prior diagnosis of hypothyroidism, currently receiving levothyroxine therapy * less than 8 weeks pregnant
Exclusion criteria
* cardiac disease, renal failure * not euthyroid biochemically within 6 months pre-pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Patients in Each Treatment Arm Euthyroid Through Gestation | 9 months | The proportion of patients in each treatment arm euthyroid through gestation |
Secondary
| Measure | Time frame |
|---|---|
| the Participants in Each Arm Who Required Levothyroxine Dose Adjustments (Either Increased or Decreased) Occurred to Maintain a Euthyroid State | 9 months |
| Proportion of Subjects With Abnormal Thyroid Stimulating Hormone Values When Following an Every 4 Week Monitoring Schedule During Pregnancy. | 9 months |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 2 Tablet Increase Patients will increase their current levothyroxine dose by 2 extra tablets per week (\
29% increase) | 25 |
| 3 Tablet Increase Patients will increase their levothyroxine dosage by 3 extra tablets per week (\
43%). | 23 |
| Total | 48 |
Baseline characteristics
| Characteristic | 3 Tablet Increase | 2 Tablet Increase | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 23 Participants | 25 Participants | 48 Participants |
| Age, Continuous | 28 years STANDARD_DEVIATION 5 | 29 years STANDARD_DEVIATION 3 | 29 years STANDARD_DEVIATION 5 |
| Gender Female | 23 Participants | 25 Participants | 48 Participants |
| Gender Male | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment United States | 23 participants | 25 participants | 48 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 25 | 0 / 23 |
| serious Total, serious adverse events | 0 / 25 | 0 / 23 |
Outcome results
Primary
Proportion of Patients in Each Treatment Arm Euthyroid Through Gestation
The proportion of patients in each treatment arm euthyroid through gestation
Time frame: 9 months
Population: proportion of patients in each treatment arm euthyroid through gestation
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 2 Tablet Increase | Proportion of Patients in Each Treatment Arm Euthyroid Through Gestation | 24 participants |
| 3 Tablet Increase | Proportion of Patients in Each Treatment Arm Euthyroid Through Gestation | 21 participants |
Secondary
Proportion of Subjects With Abnormal Thyroid Stimulating Hormone Values When Following an Every 4 Week Monitoring Schedule During Pregnancy.
Time frame: 9 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 2 Tablet Increase | Proportion of Subjects With Abnormal Thyroid Stimulating Hormone Values When Following an Every 4 Week Monitoring Schedule During Pregnancy. | 25 participants |
| 3 Tablet Increase | Proportion of Subjects With Abnormal Thyroid Stimulating Hormone Values When Following an Every 4 Week Monitoring Schedule During Pregnancy. | 23 participants |
Secondary
the Participants in Each Arm Who Required Levothyroxine Dose Adjustments (Either Increased or Decreased) Occurred to Maintain a Euthyroid State
Time frame: 9 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 2 Tablet Increase | the Participants in Each Arm Who Required Levothyroxine Dose Adjustments (Either Increased or Decreased) Occurred to Maintain a Euthyroid State | 10 participants |
| 3 Tablet Increase | the Participants in Each Arm Who Required Levothyroxine Dose Adjustments (Either Increased or Decreased) Occurred to Maintain a Euthyroid State | 16 participants |