The effect of intervention by Levothyroxine on pregnancy outcome of pregnant women with isolated hypothyroxinemia

Phase 2

• Conditions: Condition 1: Preterm labor. Condition 2: Abortion. Condition 3: Low birth weight. Condition 4: Intra uterine growth restriction. Condition 5: Premature rupture of membranes. Condition 6: Third trimester hemorrhage.; Preterm labour and delivery; Slow fetal growth and fetal malnutrition; Premature rupture of membranes; Placenta previa, Premature separation of placenta [abruptio placentae]; Spontaneous abortion; Disorders related to short gestation and low birth weight, not elsewhere classified; O44 , O45

• Registration Number: IRCT2013121714849N4
• Lead Sponsor: Shahid Beheshti University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 22 February 2018

Recruitment & Eligibility

• Status: Complete
• Sex: Female
• Target Recruitment: 60

Inclusion Criteria

pregnant women during the first 20 weeks of pregnancy.should not have contraindications for taking levothyroxine contraindication of Levothyroxine include: patients with severe cardiovascular diseases such as coronary heart failure, history of myocardial infarction, uncontrolled hypertension.

Exclusion Criteria

Not provided

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Abortion. Timepoint: Up to 20 weeks of pregnancy (In cases that intervention begins in first trimester). Method of measurement: Checklist.;Preterm labor. Timepoint: 20 to 37 weeks of pregnancy (within 1 to 6 months after intervention). Method of measurement: Checklist.;Low birth weight. Timepoint: After birth (5 to 7 months after intervention). Method of measurement: Checklist.;Intra uterine growth restriction. Timepoint: 5 to 7 months after intervention. Method of measurement: Checklist.;Premature rupture of membranes (PROM). Timepoint: 5 to 7 months after intervention. Method of measurement: Checklist.;Third trimester hemorrhage. Timepoint: Third trimester (2 to 5 months after intervention). Method of measurement: Checklist.;TSH level of newborn at birth (day 3 to5 births). Timepoint: 3 to 5 days after birth (5 to 7 months after intervention). Method of measurement: Immunoradiometric assay (IRMA).