The Obstetric Cook Double Balloon Catheter in Combination With Oral Misoprostol for Induction of Labor
| Status: | Recruiting |
|---|---|
| Conditions: | Women's Studies |
| Therapuetic Areas: | Reproductive |
| Healthy: | No |
| Age Range: | 18 - 50 |
| Updated: | 12/1/2017 |
| Start Date: | April 2013 |
| End Date: | October 2016 |
| Contact: | Meg Hill, MBBS |
| Email: | meg.hill@hotmail.com |
| Phone: | 520 626 6174 |
The Obstetric Cook Double Balloon Catheter in Combination With Oral Misoprostol for Induction of Labor: A Double-Blinded, Randomized Controlled Trial
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.
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.
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
We found this trial at
1
site
Tucson, Arizona 85721
(520) 621-2211
Principal Investigator: Meg Hill, MBBS
Phone: 520-626-6174
University of Arizona The University of Arizona is a premier, public research university. Established in...
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