The Obstetric Cook Double Balloon Catheter in Combination With Oral Misoprostol for Induction of Labor
Status unconfirmed · Phase 2 · Has a placebo group
Conditions studied: Labor Induction
In brief
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.
Key facts
- Study ID
- NCT01866488
- Run by
- University of Arizona
- People needed
- 200
- Starts
- 2013-04-01
- Expected to finish
- 2016-10-01
- Last updated by the study team
- 2016-08-30
Who can join
Age: 18 and older, up to 50. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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.
- 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
Where it is running
- University of Arizona — Tucson, Arizona, United States (enrolling)
Full record on ClinicalTrials.gov
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