The Obstetric Cook Double Balloon Catheter in Combination With Oral Misoprostol for Induction of Labor
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ClinicalTrials.gov Identifier: NCT01866488 |
Recruitment Status
:
Recruiting
First Posted
: May 31, 2013
Last Update Posted
: August 30, 2016
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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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Labor Induction | Drug: Misoprostol Other: Placebo | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 200 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Care Provider, Investigator) |
Primary Purpose: | Treatment |
Official Title: | The Obstetric Cook Double Balloon Catheter in Combination With Oral Misoprostol for Induction of Labor: A Double-Blinded, Randomized Controlled Trial |
Study Start Date : | April 2013 |
Estimated Primary Completion Date : | October 2016 |
Estimated Study Completion Date : | October 2016 |

Arm | Intervention/treatment |
---|---|
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.
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Drug: Misoprostol
Other Name: Cytotec
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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.
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Other: Placebo |
- Occurence of cesarean section [ Time Frame: Within 96 hours from the commencement of the Induction of Labor ]
- Time from start of induction of labor to vaginal delivery [ Time Frame: 24, 48 and 72 hours ]
- Change in cervical bishop score with allotted treatment [ Time Frame: 6 hours ]

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Ages Eligible for Study: | 18 Years to 50 Years (Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01866488
Contact: Meg Hill, MBBS | 520 626 6174 | meg.hill@hotmail.com |
United States, Arizona | |
University of Arizona | Recruiting |
Tucson, Arizona, United States, 85718 | |
Contact: Meg Hill, MBBS 520-626-6174 meg.hill@hotmail.com | |
Contact: Maritza Gonzalez, MD 520 626 6174 mgonzalez@obgyn.arizona.edu | |
Principal Investigator: Meg Hill, MBBS | |
Sub-Investigator: Maritza Gonzalez, MD |
Principal Investigator: | Meg Hill, MBBS | University of Arizona |
Responsible Party: | Meg Hill, Fellow, Maternal Fetal Medicine, University of Arizona |
ClinicalTrials.gov Identifier: | NCT01866488 History of Changes |
Other Study ID Numbers: |
12-1027-01 |
First Posted: | May 31, 2013 Key Record Dates |
Last Update Posted: | August 30, 2016 |
Last Verified: | August 2016 |
Keywords provided by Meg Hill, University of Arizona:
Labor induction Misoprostol Cytotec Cook Obstetric Double Balloon Catheter |
Additional relevant MeSH terms:
Misoprostol Abortifacient Agents, Nonsteroidal Abortifacient Agents Reproductive Control Agents |
Physiological Effects of Drugs Anti-Ulcer Agents Gastrointestinal Agents Oxytocics |