NCT07121634

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

Cervical Ripening With Misoprostol Versus Isosorbide Mononitrate in Late-term Pregnancies: A Prospective Parallel -Arm Randomized Controlled Trial

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Raid M. Al-Ani · Academic / Other
• Sex: Female
• Age: 18 Years – 40 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This randomized controlled trial evaluates the effectiveness and safety of misoprostol versus isosorbide mononitrate (IMN) for cervical ripening in prolonged pregnancies (≥41+0 weeks gestation). Favorable cervical status, reflected by a Bishop Score ≥6, is critical for successful vaginal delivery. Participants are low-risk pregnant women at 41+6 weeks with an unfavorable cervix. They are randomized to receive either 25 mcg of vaginal misoprostol or 40 mg of vaginal IMN, administered every 4 hours for up to 3 doses. Cervical status is assessed at regular intervals to determine the achievement of cervical ripening within 40 hours. The primary outcome is the proportion of participants achieving a Bishop Score ≥6. Secondary outcomes include maternal parameters (labor progression, cesarean section rate, postpartum hemorrhage) and neonatal outcomes (Apgar scores, fetal heart rate tracing, and Doppler indices). The study aims to determine which agent more effectively facilitates cervical ripening and supports favorable delivery outcomes in late-term pregnancies.

Conditions

• Cervical Ripening

Interventions

Type	Name	Description
DRUG	Misoprostol 25 µg Vaginal	The Misoprostol group (n=40) were Misoprostol cases, a synthetic PGE1 in the form of vaginal tablets of 25 µg (Vagiprost; ADWIA Co/Egypt) applied locally to the posterior fornix every 4 hours for cervical ripening before induction of labor is started (up to 3-doses).
DRUG	Isosorbide Mononitrate	The Isosorbide Mononitrate group (n=40) were nitric acid donor cases applied to the posterior fornix prior to induction of labor. Isosorbide mononitrate (IMN) (Monomack; Mack Pharmaceutics; Jordan) in a vaginal dose of 40 mg was used every 4 hours (up to 3 doses). Women who scored a BS of \> 6 from the assigned time were labelled as (1), after the passage of 40 hours, while those women whose BS was less than 6 were labelled (0) for construction of the Kaplan Meier curve for both groups.

Timeline

• Start date: 2024-01-01
• Primary completion: 2025-08-20
• Completion: 2026-08-31
• First posted: 2025-08-13
• Last updated: 2025-08-13

Locations

1 site across 1 country: Iraq