Comparison of Misoprostol and Prostaglandin E2 (PGE2) Gel for Induction of Labour in Premature Rupture of Membranes at Term

Comparison of Misoprostol and PGE2 Gel for Induction of Labour in in Premature Rupture of Membranes at Term- A Randomized Comparative Trial

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00355303

Enrollment

932

Registered

2006-07-21

Start date

2006-08-31

Completion date

2013-05-31

Last updated

2015-07-22

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

Conditions

Premature Rupture of Membranes at Term

Keywords

Premature rupture of membranes at term, Induction of labour, Misoprostol, PGE2 gel, Immediate induction with PGE2 gel, Immediate induction with Misoprostol

Brief summary

The purpose of this study is to determine whether induction of labor with vaginal misoprostol application will result in fewer cesarean deliveries than vaginal PGE2 gel application in women with premature rupture of membranes at term.

Interventions

DRUGMisoprostol

Vaginal application of Misoprostol tablets at 4 hrly interval with maximumof five doses

DRUGPGE2 gel

PGE2 gel will be applied in poaterior fornix at six hrly interval with maximum of 2 doses

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Healthy volunteers

Inclusion criteria

* Premature rupture of membranes at 37 or more weeks * Single live fetus in cephalic presentation

Exclusion criteria

* Women in labour * Women with contraindication of induction of labour * Women with previous caesarean section or uterine surgery

Design outcomes

Primary

Measure	Time frame
Caesarean Section rate	48 hours

Secondary

Measure	Time frame
Induction delivery time	48 hours
Neonatal & maternal infectious morbidity	14 days following date of delivery

Countries

India

Outcome results

None listed

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