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| Sponsored by: |
Nilratan Sircar Medical College |
|---|---|
| Information provided by: | Nilratan Sircar Medical College |
| ClinicalTrials.gov Identifier: | NCT00355303 |
Purpose
The purpose of this study is to determine whether induction of labour with vaginal misoprostol application will result in fewer caesarean deliveries than vaginal PGE2 gel application in women with premature rupture of membranes at Term.
| Condition | Intervention | Phase |
|---|---|---|
|
Premature Rupture of Membranes at Term |
Drug: Misoprostol in arm A & PGE2 Gel in arm B |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
| Estimated Enrollment: | 1300 |
| Study Start Date: | August 2006 |
| Estimated Primary Completion Date: | August 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
misoprostol -A & PGE2 gel-B: Active Comparator
participants are assigned to one of two arms for the duration of the study In arm A of study induction of labour is done by intravaginal misoprostol & in arm B, induction of labour is done by PGE2 gel application in posterior fornix and the outcomes will be compared
|
Drug: Misoprostol in arm A & PGE2 Gel in arm B
In arm A Intravaginal Misoprostol is applied 25 microgram 4 hourly a maximum of five doses. In arm B PGE2 gel is applied at 6 hour interval with a maximum of 2 doses.
|
Eligibility| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Snehamay Chaudhuri, MBBS,MD,DNB | 91-33-23537900 | snehamay_chaudhuri_dr@yahoo.com |
| India, West Bengal | |
| Nilratan Sircar Medical College, 138,AJC Bose Road, | Recruiting |
| Kolkata, West Bengal, India, 700014 | |
| Contact: Snehamay Chaudhuri, MBBS,MD,DNB 91-33-23537900 snehamay_chaudhuri_dr@yahoo.com | |
| Principal Investigator: | Snehamay Chaudhuri, MBBS,MD.DNB | Nilratan Sircar Medical College , Kolkata, West bengal , India |
More Information
| Responsible Party: | Nilratan Sircar Medical College , West Bengal , Kolkata ( Dr Snehamay Chaudhuri, Assistant Professor , Department of Gyne & Obstetrics ) |
| Study ID Numbers: | 2-Chaudhuri |
| Study First Received: | July 19, 2006 |
| Last Updated: | July 2, 2008 |
| ClinicalTrials.gov Identifier: | NCT00355303 |
| Health Authority: | India: Ministry of Health |
|
Premature rupture of membranes at term Induction of labour Misoprostol |
PGE2 gel Immediate induction with PGE2 gel Immediate induction with Misoprostol |
|
Dinoprostone Pregnancy Complications Misoprostol Wounds and Injuries |
Obstetric Labor Complications Disorders of Environmental Origin Rupture Fetal Membranes, Premature Rupture |
|
Oxytocics Therapeutic Uses Anti-Ulcer Agents Abortifacient Agents Physiological Effects of Drugs |
Gastrointestinal Agents Reproductive Control Agents Abortifacient Agents, Nonsteroidal Pharmacologic Actions |
