Cervical Ripening With Misoprostol vs Isosorbide Mononitrate ; A Parallel -Arm Randomized Control… (NCT07121634) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Cervical Ripening With Misoprostol vs Isosorbide Mononitrate ; A Parallel -Arm Randomized Controlled Trial
Iraq80 participantsStarted 2024-01-01
Plain-language 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.
Who can participate
Age range
18 Years – 40 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Cervical Ripening Success
Timeframe: Time Frame: Up to 40 hours post-intervention