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

NCT ID: NCT07121634

Last Updated: 2025-08-13

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-01
• Study Completion Date: 2026-08-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Misoprostol group

Misoprostol Group Arm Type: Experimental

Arm Description:

Participants in this group received 25 µg of Misoprostol (Vagiprost; ADWIA Co/Egypt) administered vaginally every 4 hours, up to a maximum of 3 doses, for cervical ripening before induction of labor.

Assigned Intervention:

Drug Name: Misoprostol

• Other Names: Vagiprost, synthetic prostaglandin E1

Group Type: EXPERIMENTAL

Misoprostol 25 µg Vaginal

Intervention Type: DRUG

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 Group

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).

Group Type: EXPERIMENTAL

Isosorbide Mononitrate

Intervention Type: DRUG

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.

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).

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

Cytotec Vagiprost PGE1 analogue; IMN, Monomack, Nitric oxide donor

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Raid M. Al-Ani

OTHER

Sponsor Role: lead

Responsible Party

Raid M. Al-Ani

Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Wassan Nori, PhD

Role: PRINCIPAL_INVESTIGATOR

Al-Mustansiriyah University

Locations

Yarmouk

Baghdad, , Iraq

Countries

Iraq

Other Identifiers

University of Anbar

Identifier Type: -

Identifier Source: org_study_id