UnknownPhase 4

Dinoprostone Induction vs. Expectant Management After PROM at Term

70 participantsStarted 2022-06

Plain-language summary

Prelabour rupture of membranes (PROM) is associated with intrauterine infection and maternal and neonatal consequences. This risk increases with the length of time from PROM to delivery. Induction of labor has been shown to reduce the rates of those complications, however the optimal time interval has not yet been determined. The main purpose of this single-center randomized prospective study is to assess the differences between two approaches of managing PROM at term-expectant management and induction with a dinoprostone vaginal delivery system.

Who can participate

Age range

18 Years – 50 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: * 4 to12 hours after prelabour rupture of membranes * 18-50 years of age * Parity 0 to 2 * Singleton pregnancy * Cephalic presentation * Term (37-41 6/7 weeks gestational age) * Bishop score ≤5 * Reassuring fetal status Exclusion Criteria: * Uterine contractions * Signs of infection * Signs of non-reassuring fetal status * Meconium-stained amniotic fluid * Group B Streptococcus colonization * Fetal demise or major congenital anomaly * Intrauterine growth restriction (estimated fetal weight ≤ 3 percentile) * Contraindications for vaginal birth or use of prostaglandins for labor induction

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

Time from randomisation to delivery

Timeframe: Within 1 week

Trial details

NCT IDNCT05430711

SponsorUniversity Medical Centre Ljubljana

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-06

Contact for this trial

Polona Pečlin

0038615526162 polona.peclin@kclj.si

View on ClinicalTrials.gov More Prelabor Rupture of Membranes trials