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Comparison of Oral Misoprostol Tablets and Oxytocin for the Induction of Labor inPremature Rupture of Membranes

Comparison of Oral Misoprostol Tablets and Oxytocin for the Induction of Labor inPremature Rupture of Membranes

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20191014045106N1
Enrollment
160
Registered
2020-02-19
Start date
2019-11-22
Completion date
Unknown
Last updated
2020-02-24

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

Conditions

Labor in premature rupture of fetal protective membranes. Encounter for routine child health examination

Interventions

Intervention 1: Intervention group:The case group will be given 50 micrograms of misoprostol orally every 4 hours up to a maximum of 5 doses. Intervention 2: Control group:In the control group, oral p

Sponsors

Shahid Beheshti University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: Definitive diagnosis of rupture of the sachet on examination with speculum or positive frenne test Gestational age between 34 and 42 weeks Cephalic presentation Bishop score =5 Indication of vaginal termination of pregnancy Parity less than five Absence of active labor Absence of active labor

Exclusion criteria

Exclusion criteria: The presence of any fetal heart rate abnormalities A history of cesarean section or uterine scarring Contraindications for vaginal delivery such as placenta peria Known allergy to prostaglandin (skin manifestations, hives, rash, shortness of breath, cough, chest pain and blurred vision after previous prostaglandin use) Estimated baby weight over 4 kg Active labor means at least 3 contractions with sufficient force and duration of at least 40 seconds within 10 minutes. Active cardiovascular disease, asthma, glaucoma Vaginal bleeding

Design outcomes

Primary

MeasureTime frame
Age. Timepoint: Baseline. Method of measurement: questionnaire.;Pregnancy age. Timepoint: Baseline. Method of measurement: questionnaire.;Delivery time. Timepoint: During delivery. Method of measurement: questionnaire.;First and fifth minute apgar. Timepoint: First and fifth minute. Method of measurement: Based on Apgar score determination by examiner.;Postpartum hemorrhage. Timepoint: Immediately after delivery. Method of measurement: View by examiner / Yes, No.;Excretion of neonatal meconium. Timepoint: After birth. Method of measurement: View by examiner / Yes, No.

Secondary

MeasureTime frame
Side Effects Of Misoprostol. Timepoint: Postpartum. Method of measurement: Question about person / fever, nausea, Vomiting, diarrhea.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMaryam Mohammadi

Shahid Beheshti University of Medical Sciences

dr.maryam671@gmail.com+98 21 5506 2644

Outcome results

None listed

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