Recruiting
Phase 2

Obstetric Cook Catheter & Misoprostol

Sponsor:

University of Arizona

Code:

NCT01866488

Conditions

Labor Induction

Eligibility Criteria

Sex: Female

Age: 18 - 50

Healthy Volunteers: Not accepted

Interventions

Misoprostol

Placebo

Study Details

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.

Conditions

Labor Induction

Study ID

NCT01866488

Start date

Apr, 2013

Status verified date

Aug, 2016

Completion date

Oct, 2016

Anticipated

Primary completion date

Oct, 2016

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 50

Healthy Volunteers: Not accepted

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 Design

Enrollment

200 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

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.

Interventions

Misoprostol

Placebo

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Meg Hill, MBBS

520 626 6174meg.hill@hotmail.com

Locations

University of Arizona

Recruiting

Tucson, Arizona, United States, 85718

Contacts

Meg Hill, MBBS

520-626-6174meg.hill@hotmail.com

Maritza Gonzalez, MD

520 626 6174mgonzalez@obgyn.arizona.edu

Principal Investigator:

Meg Hill, MBBS

More Information

Sponsor

University of Arizona

Last update posted

Aug 30, 2016

Last verified

Aug, 2016

Keywords

  • Labor induction
  • Misoprostol
  • Cytotec
  • Cook Obstetric Double Balloon Catheter

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Arizona on 2016-08-30.