CompletedPhase 4

Nitric Oxide Donor Isosorbide Mono Nitrate for Cervical Ripening in Induction of Labor

Egypt160 participantsStarted 2023-12-01

Plain-language summary

The study aims to evaluate and assess the effectiveness and safety of vaginal administration of isosorbide mono nitrate (IMN) to induce cervical ripening and shorten the interval time between induction and delivery in women undergoing induction of labor. Research Hypothesis: In women undergoing induction of labor, vaginal administration of isosorbide mono nitrate (IMN) is effective to induce cervical ripening and shorten the interval time between induction and delivery. Research Questions: Does vaginal administration of isosorbide mono nitrate (IMN) induce cervical ripening and shorten the interval time between induction and delivery in women undergoing induction of labor?

Who can participate

Age range

20 Years – 35 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: * Singleton pregnancy. * Cephalic presentation. * Bishop score \< 6. * Average size of the fetus. * Adequate pelvic dimensions. * Term or post-term pregnancies with an indication for labor induction either maternal or fetal. Exclusion Criteria: * • Previous uterine scar. * Patients with regular uterine contractions. * Malpresentation. * Multifetal gestation. * Prelabour rupture of membranes. * Established fetal distress. * Indication for CS, e.g. Major degree of cephalopelvic disproportion and fetal macrosomia. * Antepartum hemorrhage. * Active genital herpes infection. * Severe maternal illness (e.g. severe preeclampsia).

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

admission-delivery interval

Timeframe: up to 24 hours

Trial details

NCT IDNCT03544606

Sponsorahmed nagy shaker ramadan

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-06-15

View on ClinicalTrials.gov More Induction of Labor Affected Fetus / Newborn trials