]>
IRCT2013121714849N4 IRCT 2014-01-06 Shahid Beheshti University of Medical Sciences The effect of intervention by Levothyroxine on pregnancy outcome of pregnant women with isolated hypothyroxinemia Assessment of the effect of Levothyroxine on pregnancy outcome in comparison with placebo in pregnant women with isolated hypothyroxinemia 2013-10-23 anticipated 60 Complete https://irct.ir/trial/14327 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: In this clinical trial no subject knows whether she is receiving particular treatments (levothyroxine) or lack of treatment (placebo), but the administrator does have that information. 2 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. Intervention 1: Intervention group will treat with LT4: these patients will receive a dose of 0.5 microgram/kg.d if they have TSH less than 1.0 mIU/liter, 0.75 microgram/kg.d for TSH between 1.0 and 2.0 mIU/liter, and 1 microgram/kg.d for TSH higher than 2.0 mIU/liter. Dosages will maintain throughout gestation. Intervention 2: Will take placebo.
public Sima Nazarpour
School of Nursing and Midwifery, Niayesh st., Vali Asr Ave., Tehran, Iran
Tehran Iran (Islamic Republic of) +98 21 8865 5366 simanazarpour@sbmu.ac.ir; nazarpoursima@yahoo Shahid Beheshti University of Medical Sciences, Midwifery and Nursing department scientific Fahimeh Ramezani Tehrani
Velenjak St. , Shahid Chamran Highway, Tehran, Iran
Tehran Iran (Islamic Republic of) +98 21 2243 2500 fah.tehrani@gmail.com Research Institute for Endocrine Sciences, Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) 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. 15 years 49 years Female O60 O03 P07 P05 O42 O44 , O45 Preterm labour and delivery Spontaneous abortion 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] Treatment - Drugs Placebo Intervention group will treat with LT4: these patients will receive a dose of 0.5 microgram/kg.d if they have TSH less than 1.0 mIU/liter, 0.75 microgram/kg.d for TSH between 1.0 and 2.0 mIU/liter, and 1 microgram/kg.d for TSH higher than 2.0 mIU/liter. Dosages will maintain throughout gestation. Will take placebo. 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). Thyroid hormones (T4, T3 uptake, TSH) in second and third trimester. Timepoint: 20th and 30th week of pregnancy. Method of measurement: T4: Radioimmuno assay (RIA), TSH: Immunoradiometric assay (IRMA), T3uptake: ELISA. Blood pressure. Timepoint: After the intervention, during routine care in pregnancy (16 to 20 weeks, 26 to 30 weeks, 31 to 34 weeks, 35 to 37 weeks, 38 weeks, 39 weeks, 40 or 41 weeks of gestation) and during labor. Method of measurement: Blood pressure measuring devices. Edema. Timepoint: After the intervention, during routine care in pregnancy (16 to 20 weeks, 26 to 30 weeks, 31 to 34 weeks, 35 to 37 weeks, 38 weeks, 39 weeks, 40 or 41 weeks of gestation). Method of measurement: Checklist. Fetal heart rate (FHR). Timepoint: After the intervention, during routine care in pregnancy (16 to 20 weeks, 26 to 30 weeks, 31 to 34 weeks, 35 to 37 weeks, 38 weeks, 39 weeks, 40 or 41 weeks of gestation) and during labor. Method of measurement: Pinard Stethoscope. Headache. Timepoint: After the intervention, during routine care in pregnancy (16 to 20 weeks, 26 to 30 weeks, 31 to 34 weeks, 35 to 37 weeks, 38 weeks, 39 weeks, 40 or 41 weeks of gestation). Method of measurement: Checklist. Vaginal bleeding. Timepoint: After the intervention, during routine care in pregnancy (16 to 20 weeks, 26 to 30 weeks, 31 to 34 weeks, 35 to 37 weeks, 38 weeks, 39 weeks, 40 or 41 weeks of gestation) and during labor. Method of measurement: Checklist. Uterine contractions. Timepoint: After the intervention, during routine care in pregnancy (16 to 20 weeks, 26 to 30 weeks, 31 to 34 weeks, 35 to 37 weeks, 38 weeks, 39 weeks, 40 or 41 weeks of gestation). Method of measurement: Checklist. Type of delivery. Timepoint: Delivery (5 to 7 months after intervention). Method of measurement: Checklist. Postpartum atonia. Timepoint: Postpartum (5 to 7 months after intervention). Method of measurement: Checklist. Postpartum hemorrhage. Timepoint: Postpartum (5 to 7 months after intervention). Method of measurement: Checklist. Newborn Apgar. Timepoint: After birth (5 to 7 months after intervention). Method of measurement: Apgar Apgar scoring. Hospitalization in neonatal intensive care unit (NICU). Timepoint: After birth (5 to 7 months after intervention). Method of measurement: Checklist. Newborn convulsion. Timepoint: After birth (5 to 7 months after intervention). Method of measurement: Checklist. Newborn icterus. Timepoint: After birth (5 to 7 months after intervention). Method of measurement: Checklist. Shahid Beheshti University of Medical Sciences Approved 2013-10-15 Ethics committee of Shahid Beheshti University of Medical Sciences, Research Institute for Endocrin Velenjak St., Shahid Chamran Highway, Tehran, Iran Tehran Iran (Islamic Republic of)