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IRCT2013121214849N3 IRCT 2014-01-06 Shahid Beheshti University of Medical Sciences The effect of Levothyroxine on pregnancy outcome of pregnant women with subclinical hypothyroidism and negative thyroid peroxidase antibody Assessment of the effect of Levothyroxine on pregnancy outcome in pregnant women with subclinical hypothyroidism and negative thyroid peroxidase antibody 2013-10-23 anticipated 1600 Complete https://irct.ir/trial/14326 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Study subjects are randomly divided into two groups using permuted block randomization to achieve balance across treatment groups. The number of subjects per block will be four, Blinding description: A sealed opaque envelope will be assigned to each subject, only the midwife treating the women, who will not participate in any subsequent phase of the study, knows in which group each patient is. 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: The control group does not receive intervention. https://academic.oup.com/jcem/article-abstract/103/3/926/4590237?redirectedFrom=fulltext Context Currently, there is no consensus on universal thyroid screening and levothyroxine (LT4) treatment of pregnant women with subclinical hypothyroidism (SCH) who are negative for thyroid peroxidase antibody (TPOAb−). Objective We aimed to evaluate the benefits of LT4 treatment on pregnancy outcomes in SCH-TPOAb− women. Design This study was conducted within the framework of the Tehran Thyroid and Pregnancy Study. A single-blind randomized clinical trial was undertaken in pregnant women who were SCH-TPOAb−. Setting Prenatal care centers of the Shahid Beheshti University of Medical Sciences. Patients Using the thyrotropin (TSH) cut point of 2.5 mIU/L, 366 SCH-TPOAb− and 1092 euthyroid TPOAb− women were recruited. Intervention SCH-TPOAb− women were randomly assigned to two groups: group A (n = 183) who were treated with LT4 and group B (n = 183) who received no treatment. A total of 1,028 euthyroid TPOAb− women served as the control group (group C). Main Outcome Measure The primary outcome was the rate of preterm delivery. Results Using the TSH cutoff of 2.5 mIU/L, no significant difference in preterm delivery was observed between groups A and B [relative risk (RR): 0.86; 95% confidence interval (CI): 0.47 to 1.55; P = 0.61]. However, log-binomial model analysis based on a cut point of 4.0 mIU/L demonstrated a significantly lower rate of preterm delivery in LT4-treated women compared with those who received no treatment (RR: 0.38; 95% CI: 0.15 to 0.98; P = 0.04). Conclusions Despite no beneficial effect of LT4 therapy in reducing preterm delivery in SCH-TPOAb− women with a TSH cut point of 2.5 to 4 mIU/L, LT4 could precisely decrease this complication using the newly recommended cutoff ≥4.0 mIU/L. No - There is not a plan to make this available Justification or reason for not sharing IPD is -
public Sima Nazarpour
School of Nursing and Midwifery, Niayesh st., Vali Asr Ave., Tehran, Iran
Tehran Iran (Islamic Republic of) 1985717413 +98 21 8865 5366 simanazarpour@sbmu.ac.ir Shahid Beheshti University of Medical Sciences scientific Fahimeh Ramezani Tehrani
Velenjak St. , Shahid Chamran Highway, Tehran, Iran
Tehran Iran (Islamic Republic of) 1985717413 +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. 15 years 49 years Female contraindication of Levothyroxine use include: patients with severe cardiovascular diseases such as coronary heart failure, history of myocardial infarction, uncontrolled hypertension 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 N/A 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. The control group does not receive intervention. 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 Research Institute for Endocrine Sciences, Shahid Beheshti University of Medical Velenjak St., Shahid Chamran Highway, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)