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

August 27, 2016 updated by: Meg Hill, University of Arizona

The Obstetric Cook Double Balloon Catheter in Combination With Oral Misoprostol for Induction of Labor: A Double-Blinded, Randomized Controlled Trial

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 Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Tucson, Arizona, United States, 85718
        • Recruiting
        • University of Arizona
        • Contact:
        • Contact:
        • Principal Investigator:
          • Meg Hill, MBBS
        • Sub-Investigator:
          • Maritza Gonzalez, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Occurence of cesarean section
Time Frame: Within 96 hours from the commencement of the Induction of Labor
Within 96 hours from the commencement of the Induction of Labor

Secondary Outcome Measures

Outcome Measure
Time Frame
Time from start of induction of labor to vaginal delivery
Time Frame: 24, 48 and 72 hours
24, 48 and 72 hours

Other Outcome Measures

Outcome Measure
Time Frame
Change in cervical bishop score with allotted treatment
Time Frame: 6 hours
6 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Arizona

Investigators

  • Principal Investigator: Meg Hill, MBBS, University of Arizona

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2013

Primary Completion (Anticipated)

October 1, 2016

Study Completion (Anticipated)

October 1, 2016

Study Registration Dates

First Submitted

April 30, 2013

First Submitted That Met QC Criteria

May 28, 2013

First Posted (Estimate)

May 31, 2013

Study Record Updates

Last Update Posted (Estimate)

August 30, 2016

Last Update Submitted That Met QC Criteria

August 27, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12-1027-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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