A Phase 4 interventional study of Misoprostol and PGE2 gel in Premature Rupture of Membranes at Term, sponsored by Nilratan Sircar Medical College. Completed at 1 site in India. Open to female participants. Per ClinicalTrials.gov, last updated 2015-07-22.
Sponsored by Nilratan Sircar Medical College · Phase 4, Interventional, and Treatment
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.
Nilratan Sircar Medical College is the lead sponsor of 8 studies on the registry; none are open to participants now.
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participants are assigned to one of two arms for the duration of the study In one group induction of labour is done by intravaginal misoprostol tablets at 4 hrly interval with maximum of five doses.In other group PGE2 gel is applied in poaterior fornix at six hourly interval.
Drug: Misoprostol · Drug: PGE2 gel
Vaginal application of Misoprostol tablets at 4 hrly interval with maximumof five doses
Also known as: Misoprost
PGE2 gel will be applied in poaterior fornix at six hrly interval with maximum of 2 doses
Also known as: Dinoprostone gel
Caesarean Section rate
Time frame: 48 hours
Induction delivery time
Time frame: 48 hours
Neonatal & maternal infectious morbidity
Time frame: 14 days following date of delivery
The record gives a start of Aug 2006, a primary completion of May 2013 and a completion of May 2013. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Jul 2015. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Misoprostol · Dinoprostone
Nilratan Sircar Medical College