Efficacy of Low Dose Levothyroxine During Pregnancy

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

Study Overview

• Status: Completed
• Conditions: Euthyroid Females
• Intervention / Treatment: Drug: levothyroxin

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 Type: Interventional
• Enrollment (Actual): 180
• Phase: Phase 3

Contacts and Locations

Study Locations

• Egypt
  • Abbassya
    • Cairo, Abbassya, Egypt
      • AinShams university maternity hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
1st trimester miscarriage	1st trimester spontaneous or missed abortion	during 1st 13 weeks of pregnancy

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Ain Shams University

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 1, 2017
• Primary Completion (ACTUAL): August 30, 2020
• Study Completion (ACTUAL): August 30, 2020

Study Registration Dates

• First Submitted: December 22, 2017
• First Submitted That Met QC Criteria: January 4, 2018
• First Posted (ACTUAL): January 5, 2018

Study Record Updates

• Last Update Posted (ACTUAL): October 7, 2021
• Last Update Submitted That Met QC Criteria: September 30, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: asu maternity hosp

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No