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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

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 Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	200 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Triple (Participant, Care Provider, 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
Study Start Date :	April 2013
Estimated Primary Completion Date :	October 2016
Estimated Study Completion Date :	October 2016

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 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

Outcome Measures

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Primary Outcome Measures :

1. Occurence of cesarean section [ Time Frame: Within 96 hours from the commencement of the Induction of Labor ]

Secondary Outcome Measures :

1. Time from start of induction of labor to vaginal delivery [ Time Frame: 24, 48 and 72 hours ]

Other Outcome Measures:

1. Change in cervical bishop score with allotted treatment [ Time Frame: 6 hours ]

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years to 50 Years (Adult)
Sexes 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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations 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
First Posted:	May 31, 2013
Last Update Posted:	August 30, 2016
Last Verified:	August 2016

Keywords provided by Meg Hill, 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