Assessment of the effect of Levothyroxine on pregnancy outcome of euthyroid pregnant women with positive thyroid peroxidase antibody

Phase 2

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

• Registration Number: IRCT2013100114849N1
• Lead Sponsor: Shahid Beheshti University of Medical Sciences

Brief Summary

Background: Despite some studies indicating that thyroid antibody positivity during pregnancy has been associated with adverse pregnancy outcomes, evidence regarding the effects of levothyroxine (LT4) treatment of euthyroid/subclinical hypothyroid pregnant women with autoimmune thyroid disease on pregnancy outcome is limited. We aimed to assess whether pregnant women with autoimmune thyroid disease, but without overt thyroid dysfunction are affected by higher rates of adverse pregnancy outcomes. In addition, we aimed to explore whether LT4 treatment improves the pregnancy outcome of affected women.<br /> Methods: A prospective study was carried out on pregnant women from the first trimester to delivery. The study was conducted among pregnant women receiving prenatal care in centers under coverage of Shahid Beheshti University of Medical Sciences. Of a total of 1746 pregnant women, screened for thyroid dysfunction, 1028 euthyroid TPOAb negative (TPOAb-) and 131 thyroid peroxidase antibody positive (TPOAb+) women without overt thyroid dysfunction entered the second phase of the study. TPOAb+ women were randomly divided into two groups: Group A (n= 65), treated with LT4 and group B (n= 66), received no treatment. The 1028 TPOAb- women (group C) served as a normal population control group. Primary outcomes were preterm delivery and miscarriage and secondary outcomes included placenta abruption, still birth, neonatal admission and neonatal TSH levels.<br /> Results: Groups B and C displayed a lower rate of preterm deliveries compared with group A (RR=0.30, 95% CI: 0.1- 0.85, P=0.0229) and (RR= 0.23, 95% CI:0.14-0.40, P

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: 300

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).