Efficacy of Low Dose Levothyroxine During Pregnancy

Sponsor

Ain Shams University (Other)

Overall Status

Completed

CT.gov ID

NCT03391154

Collaborator

(none)

180

Enrollment

Location

Arms

Actual Duration (Months)

4.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

the effect using low dose levo thyroxine in pregnant females with TSH level more than 2.5 mU/L in the first trimester on pregnancy outcome

Condition or Disease	Intervention/Treatment	Phase
Euthyroid Females	Drug: levothyroxin	Phase 3

Detailed Description

the study aim to detect the effect of low dose levothyroxine 50 ug on pregnant females and compare it with others receiving placebo

Study Design

Study Type:

Interventional

Actual Enrollment :

180 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Efficacy of Low Dose Levothyroxine During Pregnancy

Actual Study Start Date :

May 1, 2017

Actual Primary Completion Date :

Aug 30, 2020

Actual Study Completion Date :

Aug 30, 2020

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: levothyroxine 100 pregnant female with TSH of> 2.5 mU/L but less than 4 mU/L after biochemical diagnosis of pregnancy will receive 50 ug of levothyroxine (eltroxin 50) aspen,Egypt throughout the pregnancy	Drug: levothyroxin 90 female received levothroxine
No Intervention: control 100 pregnant female with TSH of> 2.5 mU/L but less than 4 mU/L after biochemical diagnosis of pregnancy will not receive any drug throughout the pregnancy

Arm

Intervention/Treatment

Active Comparator: levothyroxine

100 pregnant female with TSH of> 2.5 mU/L but less than 4 mU/L after biochemical diagnosis of pregnancy will receive 50 ug of levothyroxine (eltroxin 50) aspen,Egypt throughout the pregnancy

Drug: levothyroxin

90 female received levothroxine

No Intervention: control

100 pregnant female with TSH of> 2.5 mU/L but less than 4 mU/L after biochemical diagnosis of pregnancy will not receive any drug throughout the pregnancy

Outcome Measures

Primary Outcome Measures

1st trimester miscarriage [during 1st 13 weeks of pregnancy]
1st trimester spontaneous or missed abortion

Secondary Outcome Measures

adverse pregnancy outcome [last 26 week of gestation]
2nd trimesteric missed or spontaneous abortion ,gestational hypertension,preeclampsia, anemia, abruptio placenta premature delivery , fetal growth restriction, low birth weight

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 40 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

females with TSH more than 2.5 mU/L and less than 4 mU/L after biochemical diagnosis of pregnancy.

Exclusion Criteria:

associated endocrinopathies (PCO/ DM/ hyperprolactinemia )
associated medical condition (HTN/ chronic kidney disease.
history of recurrent pregnancy loss

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	AinShams university maternity hospital	Cairo	Abbassya	Egypt

Sponsors and Collaborators

Ain Shams University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Radwa Rasheedy Ali, lecturer of obstetrics and gynecology, Ain Shams University

ClinicalTrials.gov Identifier:

NCT03391154

Other Study ID Numbers:

asu maternity hosp

First Posted:

Jan 5, 2018

Last Update Posted:

Oct 7, 2021

Last Verified:

Sep 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Study Results

No Results Posted as of Oct 7, 2021