Comparison of Misoprostol and PGE2 Gel for Induction of Labour in Women With Premature Rupture of Membranes at Term
|ClinicalTrials.gov Identifier: NCT00355966|
Recruitment Status : Completed
First Posted : July 25, 2006
Last Update Posted : March 25, 2010
|Condition or disease||Intervention/treatment||Phase|
|Premature Rupture of Membranes at Term||Drug: Misoprostol Drug: PGE2 gel||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||212 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Comparison of Misorostol & PGE2 Gel for Immediate Induction of Labour for Premature Ropture of Membranes at Term|
|Study Start Date :||August 2006|
|Primary Completion Date :||September 2008|
|Study Completion Date :||September 2008|
Active Comparator: A
In group A, immediate induction of labour will be done by intravaginal misoprostol 25 microgram 4 hourly , a maximum of 5 doses .
In one group of women immediate induction of labour will be done by intravaginal misoprostol 25 microgram 4 hourly , a maximum of 5 doses .
Active Comparator: B
In Group B immediate induction of labour will be done by application of vaginal PGE2 gel 0.5 gm at an interval of 6 hours , a maximum of 2 doses.
Drug: PGE2 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.
- Admission to delivery time [ Time Frame: 48 hours ]
- Caesarean Section rate [ Time Frame: 48 hours ]
- Neonatal morbidity [ Time Frame: Till discharge ]
- Maternal morbidity [ Time Frame: Till discharge ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00355966
|NRS Medicl College,138 AJC Bose Road|
|Kolkata, West Bengal, India, 700014|
|Principal Investigator:||Snehamay Chaudhuri, MBBS,MD,DNB||NRS Medical College , Kolkata, India|