The Obstetric Cook Double Balloon Catheter in Combination With Oral Misoprostol for Induction of Labor
The current study is a randomized, controlled, double-blinded trial of Obstetric Cook Catheter combined with oral misoprostol for induction of labor in pregnant patients. The primary outcome to be studied is vaginal delivery rate for the Obstetric Cook Catheter in combination with oral placebo and the Obstetric Cook Catheter in combination with oral misoprostol. Secondary outcomes to be studied include the safety of the method, composite maternal morbidity and composite neonatal morbidity.
The hypothesis is that there is a higher vaginal delivery rate in the patient whom receive both the Obstetric Cook Catheter and the oral misoprostol.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
|Official Title:||The Obstetric Cook Double Balloon Catheter in Combination With Oral Misoprostol for Induction of Labor: A Double-Blinded, Randomized Controlled Trial|
- Occurence of cesarean section [ Time Frame: Within 96 hours from the commencement of the Induction of Labor ] [ Designated as safety issue: No ]
- Time from start of induction of labor to vaginal delivery [ Time Frame: 24, 48 and 72 hours ] [ Designated as safety issue: No ]
- Change in cervical bishop score with allotted treatment [ Time Frame: 6 hours ] [ Designated as safety issue: No ]
|Study Start Date:||April 2013|
|Estimated Study Completion Date:||October 2016|
|Estimated Primary Completion Date:||October 2016 (Final data collection date for primary outcome measure)|
Experimental: Cook Catheter, Oral Misoprostol
Cook Catheter is placed and a 50mcg misoprostol tablet is given orally. A repeat dose is administered in 3 hours.
Other Name: Cytotec
Placebo Comparator: Cook Catheter, Oral Placebo
Cook Catheter is placed and a placebo tablet is given orally. A repeat dose is administered in 3 hours.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01866488
|Contact: Meg Hill, MBBS||520 626 email@example.com|
|United States, Arizona|
|University of Arizona||Recruiting|
|Tucson, Arizona, United States, 85718|
|Contact: Meg Hill, MBBS 520-626-6174 firstname.lastname@example.org|
|Contact: Maritza Gonzalez, MD 520 626 6174 email@example.com|
|Principal Investigator: Meg Hill, MBBS|
|Sub-Investigator: Maritza Gonzalez, MD|
|Principal Investigator:||Meg Hill, MBBS||University of Arizona|