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

Phase 2

• Conditions: Labor Induction
• Interventions: Other: Placebo; Drug: Misoprostol

• Registration Number: NCT01866488
• Lead Sponsor: University of Arizona

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-04
• Study First Submitted: 2013-04-30
• Study First Submitted QC: 2013-05-28
• Study First Posted: 2013-05-31
• Status Verified: 2016-08
• Last Update Submitted: 2016-08-27
• Last Update Posted: 2016-08-30
• Primary Completion: 2016-10
• Study Completion: 2016-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 200

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.

2. 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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cook Catheter, Oral Placebo	Placebo	Cook Catheter is placed and a placebo tablet is given orally. A repeat dose is administered in 3 hours.
Cook Catheter, Oral Misoprostol	Misoprostol	Cook Catheter is placed and a 50mcg misoprostol tablet is given orally. A repeat dose is administered in 3 hours.

Primary Outcome Measures

Name	Time	Method
Occurence of cesarean section	Within 96 hours from the commencement of the Induction of Labor

Secondary Outcome Measures

Name	Time	Method
Time from start of induction of labor to vaginal delivery	24, 48 and 72 hours

Trial Locations

Locations (1)

University of Arizona; 🇺🇸 Tucson, Arizona, United States