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The Effect of Fertigest Progestrone in Threatened Preterm Labor

The evaluation of the effect of Fertigest Progestrone in comparison with placebo in threatened preterm labor at 24-32 weeks of gestation

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT2014041617034N3
Enrollment
80
Registered
2015-03-23
Start date
2014-08-23
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

Threatened preterm labor. Preterm labour and delivery

Interventions

Intervention 1: Intervention group will be administered with 400mg Fertigest Progestrone vaginal suppository, per day, until 34 weeks of gestational age. Intervention 2: Control group will be received
Treatment - Drugs
Placebo
Intervention group will be administered with 400mg Fertigest Progestrone vaginal suppository, per day, until 34 weeks of gestational age
Control group will be received one placebo vaginal suppository (gelatin capsule) per day, until 34 weeks of gestational age

Sponsors

Vice chancellor for research of Shiraz University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 45 Years

Inclusion criteria

Inclusion criteria: Inclusion Criteria: singleton pregnancy; no cerclage; intact membranes; cervical length = 25mm. Exclusion Criteria: Chorioamniotic Infectious; Rupture of membranes; Patients with cardiomyopathy; evidence of fetal growth retardation; sonographic evidence of congenital anomalies inconsistent with life

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Mean latency time until delivery. Timepoint: From starting intervention until delivery. Method of measurement: day counting.

Secondary

MeasureTime frame
Birthweight. Timepoint: At delivery. Method of measurement: Digital weight scale.;APGAR Score. Timepoint: At 1 and 5 minutes after delivery. Method of measurement: APGAR Method.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMaryam Zare Khafri

Shiraz University of Medical Sciences

zarekhafrim@sums.ac.ir+98 917 322 0076

Outcome results

None listed

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