MedTrace Logo

Thyroid Hormone Dose Adjustment in Pregnancy

NCT00230802 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2016-12-23

Study results available
· View outcomes & findings →

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.

Conditions

Interventions

DRUG

Anticipatory 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.

DRUG

levothyroxine

patients will increase levothyroxine dosage by 2 extra tablets of their current dose per week

DRUG

levothyroxine

patients will increase levothyroxine by 3 extra tablets of their current dose per week.

Sponsors & Collaborators

  • Harvard Medical School (HMS and HSDM)

    collaborator OTHER

  • Brigham and Women's Hospital

    lead OTHER

Principal Investigators

  • Erik Alexander, MD · Brigham and Women's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-07-31
Primary Completion
2010-07-31
Completion
2010-07-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00230802 on ClinicalTrials.gov