The Obstetric Cook Double Balloon Catheter in Combination With Oral Misoprostol for Induction of Labor

This study is currently recruiting participants. (see Contacts and Locations)

Verified August 2016 by University of Arizona

Sponsor:

Information provided by (Responsible Party):

Meg Hill, University of Arizona

ClinicalTrials.gov Identifier:

NCT01866488

First received: April 30, 2013

Last updated: August 27, 2016

Last verified: August 2016

History of Changes

Purpose

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	Intervention	Phase
Labor Induction	Drug: Misoprostol Other: Placebo	Phase 2


Study Type:	Interventional
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

Resource links provided by NLM:

Drug Information available for: Misoprostol

U.S. FDA Resources

Further study details as provided by University of Arizona:

Primary Outcome Measures:

Occurence of cesarean section [ Time Frame: Within 96 hours from the commencement of the Induction of Labor ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Time from start of induction of labor to vaginal delivery [ Time Frame: 24, 48 and 72 hours ] [ Designated as safety issue: No ]

Other Outcome Measures:

Change in cervical bishop score with allotted treatment [ Time Frame: 6 hours ] [ Designated as safety issue: No ]


Estimated Enrollment:	200
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)

Arms	Assigned Interventions
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.	Drug: Misoprostol 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.	Other: Placebo

Eligibility


Ages Eligible for Study:	18 Years to 50 Years (Adult)
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Single, live fetus
Cephalic (head-first) presentation
Reassuring fetal health assessment
Gestational age between 23 and 42 weeks
Maternal age 18 and above
Bishop score less than 8 in primigravidae
Bishop score less than 6 in multigravidae

Exclusion Criteria:

1. Fetal demise 2. Fetal malpresentation 3. Estimated fetal weight less than 500 grams or more than 4000 grams 4. Placenta previa 5. Non-reassuring fetal health assessment 6. Active maternal asthma exacerbation requiring additional medications from the usual medication requirements.

7. History of cesarean section 8. Rupture of amniotic membrane 9. Latex allergy 10. Spontaneous labor 11. Other contraindication to vaginal delivery 12. Allergy to misoprostol of cook catheter

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01866488

Contacts


Contact: Meg Hill, MBBS	520 626 6174	meg.hill@hotmail.com

Locations


United States, Arizona
University of Arizona	Recruiting
Tucson, Arizona, United States, 85718
Contact: Meg Hill, MBBS 520-626-6174 meg.hill@hotmail.com
Contact: Maritza Gonzalez, MD 520 626 6174 mgonzalez@obgyn.arizona.edu
Principal Investigator: Meg Hill, MBBS
Sub-Investigator: Maritza Gonzalez, MD

Sponsors and Collaborators

University of Arizona

Investigators


Principal Investigator:	Meg Hill, MBBS	University of Arizona

More Information


Responsible Party:	Meg Hill, Fellow, Maternal Fetal Medicine, University of Arizona
ClinicalTrials.gov Identifier:	NCT01866488 History of Changes
Other Study ID Numbers:	12-1027-01
Study First Received:	April 30, 2013
Last Updated:	August 27, 2016
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Arizona:


Labor induction Misoprostol Cytotec Cook Obstetric Double Balloon Catheter

Additional relevant MeSH terms:


Misoprostol Abortifacient Agents, Nonsteroidal Abortifacient Agents Reproductive Control Agents	Physiological Effects of Drugs Anti-Ulcer Agents Gastrointestinal Agents Oxytocics

ClinicalTrials.gov processed this record on September 23, 2016

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