UnknownNot Applicable

Comparing Cervical Foley Catheter, Dinoprostone and a Combination of the Two for Labor Induction

360 participantsStarted 2016-08

Plain-language summary

The investigators intend to conduct a randomized clinical trial comparing 3 methods of induction of labor in term primiparous women with singleton. First group will be women induced with Foley catheter and pitocin, second group Foley catheter and vaginal dinoprostone and third group will be induced with vaginal dinoprostone alone. The investigators compare time for induction to delivery and way of delivery.

Who can participate

Age range

18 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: * Primiparous women * 37 weeks pregnant or more * cephalic live singleton, * intact membranes * Unfavorable cervix (bishop's score 6 or less) Exclusion Criteria: * Previous cesarean section or other uterine surgery * severe IUGR * severe preeclampsia * Fetal malpresentation * Multiple gestation * Spontaneous labor (3 contraction in 10 min) * Premature rupture of membranes, PROM * Category 2 or greater fetal heart rate tracing * Contraindication for vaginal delivery * Fever * Vaginal bleeding (more than spotting or bloody show) * Severe IUGR * HIV carrier * Sensitivity to either latex or PGE2 * polyhydramnios

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 induction to delivery (in hours)

Timeframe: up to 24 hours

Mode of delivery

Timeframe: up to 24 hours

Trial details

NCT IDNCT02815865

SponsorKaplan Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2018-02

View on ClinicalTrials.gov More Failed Medical or Unspecified Induction of Labor trials