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Effect of vaginal progesterone on prevention of preterm delivery and neonatal side effects in women at risk for preterm birth

Effect of vaginal progesterone on prevention of preterm delivery and neonatal side effects in women at risk for preterm birth

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT201012273386N2
Enrollment
100
Registered
2011-04-03
Start date
2010-10-23
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

Preterm Labor Birth. Preterm labour with preterm delivery

Interventions

Intervention 1: Vaginal suppositories are given as Placebo in control group. Intervention 2: Suppositories of vaginal Progesterone 400 mg are given in intervention group.
Placebo
Treatment - Drugs
Vaginal suppositories are given as Placebo in control group
Suppositories of vaginal Progesterone 400 mg are given in intervention group

Sponsors

Semnan University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
16 Years to 37 Years

Inclusion criteria

Inclusion criteria: Inclusion: history of preterm labor birth (having at least one delivery before 37 wks of gestational age), incompetent cervix and having cerclage, uterine anomalies (septate uterus. unicornuate or bicornuate). exclusion: clinical evidence of chorioamnionitis, contraindication to use of progesterone (allergy to progesterone products, Diabetes, hypertension, hyperthyroidism, heart disease, polyhydramniose. IUGR, multiple pregnancy.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Preterm Labor Birth. Timepoint: From 16 week to 34 week. Method of measurement: Delivery.

Secondary

MeasureTime frame
Necrotising Entrocolitis. Timepoint: After Birth. Method of measurement: NICU records.;Intra Cranial Haemorrhage. Timepoint: After Birth. Method of measurement: NICU records.;Weight less than 2500 g. Timepoint: After Birth. Method of measurement: scale.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr Azam Azargoon

Semnan University of Medical Sciences

a-azargoon@sem-ums.ac.ir+98 23 1444 0225

Outcome results

None listed

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