Comparison of Misoprostol and PGE2 Gel for Induction of Labour in Women With Premature Rupture of Membranes at Term
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|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|
|Actual Primary Completion Date :||September 2008|
|Actual 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|