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

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

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
IRCT
Registry ID
IRCT2013100114849N1
Enrollment
300
Registered
2013-11-17
Start date
2013-11-22
Completion date
Unknown
Last updated
2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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]

Interventions

Sponsors

Shahid Beheshti University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
15 Years to 49 Years

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria:

Design outcomes

Secondary

MeasureTime frame
Thyroid hormones (T4, T3 uptake, TSH) in second and third trimester. Timepoint: 20th and 30th week of gestation. 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.;Postpartum hemorrhage. Timepoint: Postpartum (5 to 7 months after intervention). 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).

Primary

MeasureTime frame
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).

Countries

Iran (Islamic Republic of)

Contacts

Public ContactSima Nazarpour

Shahid Beheshti University of Medical Sciences, Midwifery and Nursing department

simanazarpour@sbmu.ac.ir+98 218865536671

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Mar 4, 2026