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

Study Overview
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Brief Summary
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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.

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

Conditions
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Labor Induction

Intervention / Treatment
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* Drug: Misoprostol
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cook Catheter, Oral Misoprostol<br>Cook Catheter is placed and a 50mcg misoprostol tablet is given orally. A repeat dose is administered in 3 hours. | Drug: Misoprostol<br> <br> * Other names: Cytotec;|
| Placebo Comparator: Cook Catheter, Oral Placebo<br>Cook Catheter is placed and a placebo tablet is given orally. A repeat dose is administered in 3 hours. | Other: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Labor induction, Misoprostol, Cytotec, Cook Obstetric Double Balloon Catheter