Cervical Ripening With Misoprostol vs Isosorbide Mononitrate ; A Parallel -Arm Randomized Controlled Trial
- Conditions
- Cervical Ripening
- Interventions
- Drug: Misoprostol 25 µg Vaginal
- Registration Number
- NCT07121634
- Lead Sponsor
- Raid M. Al-Ani
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- Female
- Target Recruitment
- 80
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Misoprostol group Misoprostol 25 µg Vaginal 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 Isosorbide Mononitrate Group 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).
- Primary Outcome Measures
Name Time Method Cervical Ripening Success Time Frame: Up to 40 hours post-intervention Proportion of participants achieving Bishop Score ≥6 within 40 hours after receiving Misoprostol or Isosorbide Mononitrate.
Unit of Measure: Percentage of participants (%)
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Yarmouk
🇮🇶Baghdad, Iraq
Yarmouk🇮🇶Baghdad, Iraq