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 range18 Years – 35 Years

SexFEMALE

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

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