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Cervical Ripening With Misoprostol vs Isosorbide Mononitrate ; A Parallel -Arm Randomized Controlled Trial
Sponsor: Raid M. Al-Ani
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.
Official title: Cervical Ripening With Misoprostol Versus Isosorbide Mononitrate in Late-term Pregnancies: A Prospective Parallel -Arm Randomized Controlled Trial
Key Details
Gender
FEMALE
Age Range
18 Years - 40 Years
Study Type
INTERVENTIONAL
Enrollment
80
Start Date
2024-01-01
Completion Date
2026-08-31
Last Updated
2025-08-13
Healthy Volunteers
No
Conditions
Interventions
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).
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.
Locations (1)
Yarmouk
Baghdad, Iraq