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

Labor Induction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01866488
• Other study ID #: 12-1027-01
• Status: Recruiting
• Phase: Phase 2
• First received: April 30, 2013
• Last updated: August 27, 2016
• Start date: April 2013
• Est. completion date: October 2016

Study information

• Verified date: August 2016
• Source: University of Arizona
• Contact: Meg Hill, MBBS
• Phone: 520 626 6174
• Email: meg.hill[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: October 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Labor Induction

Intervention

Drug:
• Misoprostol

Other:
• Placebo

Locations

Country	Name	City	State
United States	University of Arizona	Tucson	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
University of Arizona

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in cervical bishop score with allotted treatment		6 hours
Primary	Occurence of cesarean section		Within 96 hours from the commencement of the Induction of Labor
Secondary	Time from start of induction of labor to vaginal delivery		24, 48 and 72 hours