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

Raid M. Al-Ani

Status: Active, not recruiting

Conditions: Cervical Ripening

Treatments: Drug: Misoprostol 25 µg Vaginal; Drug: Isosorbide Mononitrate

Study type: Interventional

Funder types: Other

Identifiers

NCT07121634

University of Anbar

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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80 participants in 2 patient groups

Misoprostol group

Experimental group

Description:

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

Treatment:

Drug: Misoprostol 25 µg Vaginal

Isosorbide Mononitrate Group

Experimental group

Description:

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).

Treatment:

Drug: Isosorbide Mononitrate