A Trial of Prostaglandin E2 Tablets Versus Foley Catheter for Labor Induction

Cervical Ripening at Term With Prostaglandin E2 Tablets Versus Foley Catheter: a Randomized Controlled Trial

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02486679

Enrollment

300

Registered

2015-07-01

Start date

2015-07-31

Completion date

2017-07-31

Last updated

2016-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Labor, Induced

Brief summary

A randomized controlled trial comparing labor induction with vaginal PGE2 tablets and foley catheter for cervical ripening.

Interventions

DRUGProstin (PGE2) tablets

DEVICEFoley catheter

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

* Singleton term pregnancies (\>37 weeks), vertex presentation * Intact membranes * Low Bishop score (\<7) * First, second or third delivery * Medical indication for induction * Viable fetus

Exclusion criteria

* Contraindication for vaginal delivery, for PGE2 or foley catheter * Gestational age\<37 weeks, premature rupture of membranes, fetal or uterine malformations, previous cesarean section, uncertain dating, unwilling to participate in trial

Design outcomes

Primary

Measure	Time frame	Description
Time to active labor	Post labor- up to 24 hours	Hours from foley cather placement or first PGE2 tablet placment to active labor, defined as cervical dilitation \>4 cm and/or cervical effacement\>80%

Secondary

Measure	Time frame	Description
Delivery within 24 hours	post-labor - up to 24 hours	Delivery within 24 hours from foley catheter /first PGE2 tablet palcement
Cesarean section rate	post labor - up to 24 hours	Delivery via cesarean section
Maternal complications	participants will be followed for labor course and the duration of hospital stay, an expected average of 5 days	Documented complications during labor, including: excessive hemmorhage, infection (chorioamnionitis)
Neonatal complications	Neonates of participants will be followed for labor course and the duration of hospital stay, up to 1 month	Documented complications such as non-reassuring fetal heart rate, fetal pH, NICU admission, early neonatal sepsis

Countries

Israel

Contacts

Primary ContactHadas Ganer Herman, MD

hadassganer@yahoo.com972526206696

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026