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

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

IRCT

Registry ID

IRCT2013121214849N3

Enrollment

1600

Registered

2014-01-06

Start date

2013-10-23

Completion date

Unknown

Last updated

2018-09-11

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

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 pregnan

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.

Exclusion criteria

Exclusion criteria: contraindication of Levothyroxine use include: patients with severe cardiovascular diseases such as coronary heart failure, history of myocardial infarction, uncontrolled hypertension

Design outcomes

Primary

Measure	Time 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).	—

Measure

Time 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).

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Secondary

Measure	Time frame
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).	—

Measure

Time frame

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).

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactSima Nazarpour

Shahid Beheshti University of Medical Sciences

simanazarpour@sbmu.ac.ir+98 21 8865 5366

Outcome results

None listed

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