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

17-alpha-hydroxyprogesterone caproate versus vaginal progesterone suppository for the prevention of preterm birth in women with a sonographic short cervix in ARASH hospital during 2012-2013 years

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT2012082610664N1

Enrollment

304

Registered

2012-11-06

Start date

2012-11-21

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

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

Interventions

Intervention 1: intramuscular dose of 250 mg 17 - alpha-hydroxyprogesterone caproate is administered once a week until the occurrence of preterm birth or complete of 36 weeks of pregnancy. Interventi

Treatment - Drugs

intramuscular dose of 250 mg 17 - alpha-hydroxyprogesterone caproate is administered once a week until the occurrence of preterm birth or complete of 36 weeks of pregnancy

daily 400 mg progesterone vaginal suppository continues up to 36 weeks or until the occurrence of preterm birth

Eligibility

Sex/Gender

Female

Age

14 Years to 50 Years

Inclusion criteria

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

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
Neonatal 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.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactReihaneh Pirjani MD.

Tehran University of Medical Sciences

pirjani@razi.tums.ac.ir+98 21 7788 3288

Outcome results

None listed

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