Shahid Beheshti University of Medical Sciences Research Institute For Endocrine Sciences

Principal Investigator: Fahimeh Ramezani Tehrani

Professor of Obstetrics, Gynaecology and Reproductive Health -Shahid Beheshti University of Medical Sciences- Director, Reproductive Endocrinology Research Center, Research Institute for Endocrine Sciences

Approval date

June 11, 2013

Starting date

June 11, 2013

Goals

To identify the prevalence of subclinical thyroid dysfunction in pregnancy (phase 1) and assessment of the effect of Levothyroxine on pregnancy outcomes of pregnant women with subclinical thyroid dysfunction

Study population

Pregnant women attending prenatal clinics under coverage of Shahid Beheshti University of Medical Sciences, Tehran, Iran

Sampling method and sample size

First phase: Stratified, multistage probability cluster sampling method (n=3000). Second phase: Randomized clinical trial; number of sample for each group=200

Data Collection

Interview, questionnaire, physical exam, collecting of blood and urine samples for assessment of serum levels of TSH, T4, T3uptake and TPOab and urinary iodine

Follow up Methods

– Active fallow-up every 3 months to repeat all measurements.
– Active follow up delivery and/or hospitalized events.

Main Exposures

Serum levels of TSH, T4, T3 Uptake, TPO Ab and urinary Iodine

Outcomes

Pregnancy and newborn outcomes