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 May 2013 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: May 28, 2013
Last verified: May 2013
  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
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:


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: April 2015
Estimated Primary Completion Date: April 2015 (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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Single, live fetus
  2. Cephalic (head-first) presentation
  3. Reassuring fetal health assessment
  4. Gestational age between 23 and 42 weeks
  5. Maternal age 18 and above
  6. Bishop score less than 8 in primigravidae
  7. 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

No publications provided

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: May 28, 2013
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
Anti-Ulcer Agents
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Oxytocics
Reproductive Control Agents
Physiological Effects of Drugs
Abortifacient Agents, Nonsteroidal
Abortifacient Agents

ClinicalTrials.gov processed this record on July 24, 2014