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IRCT2013112014849N2 IRCT 2014-01-06 Shahid Beheshti University of Medical Sciences The effect of Levothyroxine on pregnancy outcome of pregnant women with subclinical hypothyroidism and positive thyroid peroxidase antibody Assessment of the effect of Levothyroxine on pregnancy outcome in comparison with placebo in pregnant women with subclinical hypothyroidism and positive thyroid peroxidase antibody 2013-10-23 anticipated 140 Complete https://irct.ir/trial/14325 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: 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. Intervention 1: Intervention group will treat with Levoxine (Levothyroxine sodium). These patients will receive 1 mg per kg of body weight daily levothyroxine. Dosages will maintain throughout pregnancy until delivery. In this study are used from Levothyroxine sodium 0.1 mg manufactured by Iran Hormone. Intervention 2: Will take placebo. http://www.eje-online.org/content/early/2016/11/22/EJE-16-0548.short?rss=1 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
public Sima Nazarpour
School of Nursing and Midwifery,Niayesh st., Vali Asr Ave.,Tehran, Iran
Tehran Iran (Islamic Republic of) +98 21 8865 5366 nazarpoursima@yahoo.comsimanazarpour@sbmu.ac.ir 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 O03 O60 P07 P05 O42 O44 , O45 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] Treatment - Drugs Placebo Intervention group will treat with Levoxine (Levothyroxine sodium). These patients will receive 1 mg per kg of body weight daily levothyroxine. Dosages will maintain throughout pregnancy until delivery. In this study are used from Levothyroxine sodium 0.1 mg manufactured by Iran Hormone. 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 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 Research Institute for Endocrine Sciences, Shahid Beheshti University of Medical Velenjak St. , Shahid Chamran Highway, Tehran, Iran Tehran Iran (Islamic Republic of)