Active — Not RecruitingNot Applicable

Cervical Ripening With Misoprostol vs Isosorbide Mononitrate ; A Parallel -Arm Randomized Controlled Trial

Iraq80 participantsStarted 2024-01-01

Plain-language summary

This randomized controlled trial compared misoprostol and isosorbide mononitrate (IMN) for cervical ripening in prolonged pregnancies. Low-risk women at 41+6 weeks gestation with an unfavorable cervix were randomized to receive either misoprostol or IMN. The primary outcome was the achievement of cervical ripeness (Bishop Score ≥6) within 40 hours.

Who can participate

Age range18 Years – 40 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Low-risk primigravidae * Singleton viable pregnancy * Cephalic fetal presentation * Confirmed gestational age ≥ 41+0/7 weeks * Normal fetal growth pattern * No signs of labor at the time of enrollment Exclusion Criteria: * High-risk pregnancies * Body mass index (BMI) \> 30 kg/m² * History of unexplained fetal death * Oligohydramnios or fetal distress * Abnormal placentation * Rh-negative status * Pre-existing medical conditions or contraindications to labor induction or study drugs * Fetal abnormalities * Malpresentation or malposition * Inadequate pelvimetry * Participants who developed fetal distress or failed to progress during induction and required emergency cesarean section

What they're measuring

Cervical Ripening Success

Timeframe: Time Frame: Up to 40 hours post-intervention

Trial details

NCT IDNCT07121634

SponsorRaid M. Al-Ani

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-08-20

View on ClinicalTrials.gov More Cervical Ripening trials