N/A
N=48
Thyroid Hormone Dose Adjustment in Pregnancy
Pregnancy · Hypothyroidism
Bottom Line
View on ClinicalTrials.gov: NCT00230802 ↗Enrolled (actual)
48
Serious AEs
0.0%
Results posted
Dec 2016
Primary outcome: Primary: Proportion of Patients in Each Treatment Arm Euthyroid Through Gestation — 24; 21 participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Anticipatory dose increase of levothyroxine (Drug); levothyroxine (Drug)
- Age
- Pediatric, Adult, Older Adult
- Sex
- Female
- Sponsor
- Brigham and Women's Hospital
- Primary completion
- Jul 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of Patients in Each Treatment Arm Euthyroid Through Gestation |
24; 21 | — |
| SECONDARY the Participants in Each Arm Who Required Levothyroxine Dose Adjustments (Either Increased or Decreased) Occurred to Maintain a Euthyroid State |
10; 16 | — |
| SECONDARY Proportion of Subjects With Abnormal Thyroid Stimulating Hormone Values When Following an Every 4 Week Monitoring Schedule During Pregnancy. |
25; 23 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00230802). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.