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

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

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01866488

Enrollment

200

Registered

2013-05-31

Start date

2013-04-30

Completion date

2016-10-31

Last updated

2016-08-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Labor Induction

Keywords

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

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.

Interventions

DRUGMisoprostol

OTHERPlacebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 50 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Occurence of cesarean section	Within 96 hours from the commencement of the Induction of Labor

Secondary

Measure	Time frame
Time from start of induction of labor to vaginal delivery	24, 48 and 72 hours

Other

Measure	Time frame
Change in cervical bishop score with allotted treatment	6 hours

Countries

United States

Contacts

Primary ContactMeg Hill, MBBS

meg.hill@hotmail.com520 626 6174

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026