The Obstetric Cook Double Balloon Catheter in Combination With Oral Misoprostol for Induction of Labor
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|ClinicalTrials.gov Identifier: NCT01866488|
Recruitment Status : Recruiting
First Posted : May 31, 2013
Last Update Posted : August 30, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Labor Induction||Drug: Misoprostol Other: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||The Obstetric Cook Double Balloon Catheter in Combination With Oral Misoprostol for Induction of Labor: A Double-Blinded, Randomized Controlled Trial|
|Study Start Date :||April 2013|
|Estimated Primary Completion Date :||October 2016|
|Estimated Study Completion Date :||October 2016|
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.
- Occurence of cesarean section [ Time Frame: Within 96 hours from the commencement of the Induction of Labor ]
- Time from start of induction of labor to vaginal delivery [ Time Frame: 24, 48 and 72 hours ]
- Change in cervical bishop score with allotted treatment [ Time Frame: 6 hours ]
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): NCT01866488
|Contact: Meg Hill, MBBS||520 626 firstname.lastname@example.org|
|United States, Arizona|
|University of Arizona||Recruiting|
|Tucson, Arizona, United States, 85718|
|Contact: Meg Hill, MBBS 520-626-6174 email@example.com|
|Contact: Maritza Gonzalez, MD 520 626 6174 firstname.lastname@example.org|
|Principal Investigator: Meg Hill, MBBS|
|Sub-Investigator: Maritza Gonzalez, MD|
|Principal Investigator:||Meg Hill, MBBS||University of Arizona|