Comparison of Misoprostol and PGE2 Gel for Induction of Labour in Women With Premature Rupture of Membranes at Term

Comparison of Misorostol & PGE2 Gel for Immediate Induction of Labour for Premature Ropture of Membranes at Term

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00355966

Enrollment

212

Registered

2006-07-25

Start date

2006-08-31

Completion date

2008-09-30

Last updated

2010-03-25

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, Induction of labour with Misoprostol, Induction of labour with PGE2 gel

Brief summary

Induction of labour with vaginal misoprostol, in women with premature rupture of membranes at term, results in significant shortening of induction to delivery time in comparison to vaginal PGE2 gel induction.

Interventions

DRUGMisoprostol

In one group of women immediate induction of labour will be done by intravaginal misoprostol 25 microgram 4 hourly , a maximum of 5 doses .

DRUGPGE2 gel

In other group immediate induction of labour will be done by intravaginal application of PGE2 gel 0.5 mg at an interval of 6 hours , a maximum of 2 doses.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

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
Admission to delivery time	48 hours

Secondary

Measure	Time frame
Caesarean Section rate	48 hours
Neonatal morbidity	Till discharge
Maternal morbidity	Till discharge

Countries

India

Outcome results

None listed

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