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Effect of proluton and cyclogest on perinatal outcome

Comparing the efficacy of 17a hydroxyprogesterone caproate ( proluton) versus vaginal progesterone (cyclogest) on perinatal outcome in high risk patients who undergo cerclage

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
IRCT
Registry ID
IRCT20181107041585N4
Enrollment
58
Registered
2020-07-10
Start date
2017-04-21
Completion date
Unknown
Last updated
2020-07-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Preterm birth. Onset (spontaneous) of labour before 37 completed weeks of gestation

Interventions

Intervention 1: Intervention group: 250 of 17 alpha hydroxyprogesterone caproat weekly immediately after cercelag procedure till 36 weeks of pregnancy. Intervention 2: Intervention group: 400 mg of va

Sponsors

Vice chancellor for research, Hormozgan University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: History of more than two previous preterm birth less than 34 weeks Singleton pregnancy Cervical length less than 25 mm based on latest vaginal sonography

Exclusion criteria

Exclusion criteria: Fetal anomaly Uterine cramp at the time of study Vaginal bleeding at the time of study Preterm rupture of membrane Allergy to hormonal therapy

Design outcomes

Primary

MeasureTime frame
Incidence of preterm birth. Timepoint: After 34 weeks of pregnancy. Method of measurement: Observational.

Secondary

MeasureTime frame
Gestational age at the time of delivery. Timepoint: At the time of delivery. Method of measurement: Clinical patient record.;Mode of delivery. Timepoint: At the time of delivery. Method of measurement: Clinical patient record.;Newborn weight. Timepoint: Immediately after delivery. Method of measurement: Clinical patient record.;Newborn apgar. Timepoint: Immediately after delivery. Method of measurement: Newborn clinical record.;Incidence of newborn respiratory distress syndrome. Timepoint: At birth and 28 days after birth. Method of measurement: Newborn clinical record.;Incidence of newborn sepsis. Timepoint: At birth and 28 days after birth. Method of measurement: Newborn clinical record.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactAmene Ranjbar

Hormozgan University of Medical Sciences

ranjbar662@gmail.com+98 76 3367 0285

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 21, 2026