MedTrace Logo

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

NCT07121634 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2025-08-13

No results posted yet for this study

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.

Conditions

  • Cervical Ripening

Interventions

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.

Sponsors & Collaborators

  • Raid M. Al-Ani

    lead OTHER

Principal Investigators

  • Wassan Nori, PhD · Al-Mustansiriyah University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-01
Primary Completion
2025-08-20
Completion
2026-08-31

Countries

  • Iraq

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07121634 on ClinicalTrials.gov