17-alpha-hydroxyprogesterone caproate versus vaginal progesterone suppository for the prevention of preterm birth in women with a sonographic short cervix

Phase 2

Conditions: Preterm labour.
Preterm spontaneous labour with preterm delivery Preterm labour with delivery NOS Preterm spontaneous labour with preterm delivery by caesarean section

Registration Number: IRCT2012082610664N1

Lead Sponsor: Tehran University of Medical Sciences Vice chancellor for research

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Complete

Sex: Female

Target Recruitment: 304

Inclusion Criteria

The study population consists of singleton pregnant women with gestational age of 16-24 weeks referring to ARASH hospital prenatal clinic for routine prenatal care. Exclusion criteria included multiple pregnancy; vaginal bleeding; confirmed or suspected chorioamnionit; having cervical cerclage; fetal abnormalities; congenital uterine abnormalities such as unicorn uterine; cevical congenital malformations such as hypoplasia of the cervix; history of cervical surgery such as conization; LEEP(loop electrical excision procedure); History of thromboembolic events; underlying disease such as uncontrolled hypertension; uncontrolled diabetes; thromboembolic disorders; heart disease and neurological – muscular disease.

Exclusion Criteria

Not provided

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Preterm labour. Timepoint: At the onset of intervention to preterm labor or to complete 37 weeks of pregnancy. Method of measurement: Gestational age at delivery occurred by weeks of age.

Secondary Outcome Measures

Name	Time	Method
eonatal hospitalization rates in NICU. Timepoint: from the birth day until one month. Method of measurement: Review neonatal file.;Duration of hospitalization in NICU. Timepoint: from hospitalization until discharge. Method of measurement: Review neonatal file.;Neonatal birth weight. Timepoint: after birth. Method of measurement: using neonatal scales.