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

NCT07121634 | Active Not Recruiting DMC

• 1 other identifier: University of Anbar
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Cervical Ripening

Keywords

Misoprostol; Isosorbide Mononitrate; Pregnancy, Prolonged

Outcome Measures

Primary Outcomes (1)

• Cervical Ripening Success

  Proportion of participants achieving Bishop Score ≥6 within 40 hours after receiving Misoprostol or Isosorbide Mononitrate. Unit of Measure: Percentage of participants (%)

  Time Frame: Up to 40 hours post-intervention

Other Outcomes (5)

• Cesarean Section

  during delivery

• Postpartum Hemorrhage Unit of Measure: Number of participants

  Delivery to 2 hours postpartum

• abnormal fetal heart tracing during labor

  during delivery

Study Arms (2)

Misoprostol group

EXPERIMENTAL

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

Drug: Misoprostol 25 µg Vaginal

Isosorbide Mononitrate Group

EXPERIMENTAL

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).

Drug: Isosorbide Mononitrate

Interventions

Misoprostol 25 µg Vaginal 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).

Also known as: Cytotec Vagiprost PGE1 analogue

Misoprostol group

Isosorbide Mononitrate 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.

Also known as: IMN, Monomack, Nitric oxide donor

Isosorbide Mononitrate Group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Gender Eligibility Details: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Raid M. Al-Ani: lead

Study Sites (1)

Yarmouk

Baghdad, 10052, Iraq

Location

MeSH Terms

Conditions

Pregnancy, Prolonged

Interventions

Misoprostol; isosorbide-5-mononitrate; Nitric Oxide Donors

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Prostaglandins E, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Cardiovascular Agents; Therapeutic Uses

Study Officials

• Wassan Nori, PhD

  Al-Mustansiriyah University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: blinded assessors
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Model Details: Arm 1 Arm Title: 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 Arm 2 Arm Title: Isosorbide Mononitrate Group Arm Type: Active Comparator Arm Description: Participants in this group received 40 mg of Isosorbide Mononitrate (Monomack; Mack Pharmaceutics, Jordan) administered vaginally every 4 hours, up to 3 doses, as a nitric oxide donor agent for cervical ripening. Assigned Intervention: Drug Name: Isosorbide Mononitrate • Other Names: IMN, Monomack, nitric oxide donor

Study Record Dates

• First Submitted: July 17, 2025
• First Posted: August 13, 2025
• Study Start: January 1, 2024
• Primary Completion: August 20, 2025
• Study Completion (Estimated): August 31, 2026
• Last Updated: August 13, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

IR (1)