Thyroid Hormone Dose Adjustment in Pregnancy
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00230802 |
Recruitment Status :
Completed
First Posted : October 3, 2005
Results First Posted : December 23, 2016
Last Update Posted : December 23, 2016
|
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Pregnancy Hypothyroidism | Drug: Anticipatory dose increase of levothyroxine Drug: levothyroxine | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 48 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Thyroid Hormone Dose Adjustments During Pregnancy in Women With Primary Hypothyroidism. |
Study Start Date : | July 2005 |
Actual Primary Completion Date : | July 2010 |
Actual Study Completion Date : | July 2010 |

Arm | Intervention/treatment |
---|---|
Active Comparator: 2 tablet increase
Patients will increase their current levothyroxine dose by 2 extra tablets per week (~29% increase)
|
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.
Other Names:
Drug: levothyroxine patients will increase levothyroxine dosage by 2 extra tablets of their current dose per week
Other Names:
|
Active Comparator: 3 tablet increase
Patients will increase their levothyroxine dosage by 3 extra tablets per week (~43%).
|
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.
Other Names:
Drug: levothyroxine patients will increase levothyroxine by 3 extra tablets of their current dose per week.
Other Names:
|
- Proportion of Patients in Each Treatment Arm Euthyroid Through Gestation [ Time Frame: 9 months ]The proportion of patients in each treatment arm euthyroid through gestation
- the Participants in Each Arm Who Required Levothyroxine Dose Adjustments (Either Increased or Decreased) Occurred to Maintain a Euthyroid State [ Time Frame: 9 months ]
- Proportion of Subjects With Abnormal Thyroid Stimulating Hormone Values When Following an Every 4 Week Monitoring Schedule During Pregnancy. [ Time Frame: 9 months ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | Child, Adult, Older Adult |
Sexes Eligible for Study: | Female |
Accepts 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00230802
United States, Massachusetts | |
Brigham and Women's Hospital | |
Boston, Massachusetts, United States, 02115 |
Principal Investigator: | Erik Alexander, MD | Brigham and Women's Hospital |
Responsible Party: | Erik K. Alexander, Associate Professor of Medicine, Brigham and Women's Hospital |
ClinicalTrials.gov Identifier: | NCT00230802 |
Other Study ID Numbers: |
DK44128 (completed) |
First Posted: | October 3, 2005 Key Record Dates |
Results First Posted: | December 23, 2016 |
Last Update Posted: | December 23, 2016 |
Last Verified: | October 2016 |
pregnancy hypothyroidism levothyroxine |
Hypothyroidism Thyroid Diseases Endocrine System Diseases |