Trial Outcomes & Findings for Thyroid Hormone Dose Adjustment in Pregnancy (NCT NCT00230802)

NCT ID: NCT00230802

Last Updated: 2016-12-23

Results Overview

The proportion of patients in each treatment arm euthyroid through gestation

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 48 participants
• Primary outcome timeframe: 9 months
• Results posted on: 2016-12-23

Participant Flow

Participant milestones

Measure	2 Tablet Increase Patients will increase their current levothyroxine dose by 2 extra tablets per week (\~29% increase)	3 Tablet Increase Patients will increase their levothyroxine dosage by 3 extra tablets per week (\~43%).
Overall Study STARTED	25	23
Overall Study COMPLETED	25	23
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Thyroid Hormone Dose Adjustment in Pregnancy

Baseline characteristics by cohort

Measure	2 Tablet Increase n=25 Participants Patients will increase their current levothyroxine dose by 2 extra tablets per week (\~29% increase)	3 Tablet Increase n=23 Participants Patients will increase their levothyroxine dosage by 3 extra tablets per week (\~43%).	Total n=48 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	25 Participants n=5 Participants	23 Participants n=7 Participants	48 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	29 years STANDARD_DEVIATION 3 • n=5 Participants	28 years STANDARD_DEVIATION 5 • n=7 Participants	29 years STANDARD_DEVIATION 5 • n=5 Participants
Gender Female	25 Participants n=5 Participants	23 Participants n=7 Participants	48 Participants n=5 Participants
Gender Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	25 participants n=5 Participants	23 participants n=7 Participants	48 participants n=5 Participants

PRIMARY outcome

Timeframe: 9 months

Population: proportion of patients in each treatment arm euthyroid through gestation

The proportion of patients in each treatment arm euthyroid through gestation

Outcome measures

Measure	2 Tablet Increase n=25 Participants Patients will increase their current levothyroxine dose by 2 extra tablets per week (\~29% increase)	3 Tablet Increase n=23 Participants Patients will increase their levothyroxine dosage by 3 extra tablets per week (\~43%).
Proportion of Patients in Each Treatment Arm Euthyroid Through Gestation	24 participants	21 participants

SECONDARY outcome

Timeframe: 9 months

Outcome measures

Measure	2 Tablet Increase n=25 Participants Patients will increase their current levothyroxine dose by 2 extra tablets per week (\~29% increase)	3 Tablet Increase n=23 Participants Patients will increase their levothyroxine dosage by 3 extra tablets per week (\~43%).
the Participants in Each Arm Who Required Levothyroxine Dose Adjustments (Either Increased or Decreased) Occurred to Maintain a Euthyroid State	10 participants	16 participants

SECONDARY outcome

Timeframe: 9 months

Outcome measures

Measure	2 Tablet Increase n=25 Participants Patients will increase their current levothyroxine dose by 2 extra tablets per week (\~29% increase)	3 Tablet Increase n=23 Participants Patients will increase their levothyroxine dosage by 3 extra tablets per week (\~43%).
Proportion of Subjects With Abnormal Thyroid Stimulating Hormone Values When Following an Every 4 Week Monitoring Schedule During Pregnancy.	25 participants	23 participants

Adverse Events

2 Tablet Increase

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

3 Tablet Increase

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Erik Alexander, MD

Brigham & Women's Hospital

Phone: 6177325666

Email: ekalexander@partners.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place