N/A
N=204
Cervical Ripening With a Double-lumen Balloon Catheter for Six Versus Twelve Hours
Induction of Labor Affected Fetus / Newborn
Bottom Line
View on ClinicalTrials.gov: NCT03086967 ↗Enrolled (actual)
204
Serious AEs
0.0%
Results posted
Nov 2022
Primary outcome: Primary: Time From Foley Bulb Placement to Time of Delivery. — 24.2; 24.57 hr — p=0.8
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Double-lumen balloon catheter (Device)
- Age
- Pediatric, Adult · 16+ yrs
- Sex
- Female
- Sponsor
- Wake Forest University Health Sciences
- Primary completion
- Sep 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time From Foley Bulb Placement to Time of Delivery. |
24.2; 24.57 | 0.8 |
| PRIMARY Time to Delivery of Trial of Labor After Cesarean Section |
20.62; 27.18 | 0.133 |
| PRIMARY 1 Minute Apgar Score of Trial of Labor After Cesarean Section |
7.6; 7.3 | 0.58 |
| SECONDARY Time From Foley Bulb Placement to Extrusion |
5.75; 9.25 | <0.0001 sig |
| SECONDARY Mode of Delivery--Number of Participants Having Cesarean Delivery |
34; 35 | 0.8 |
| SECONDARY Bacterial Infection (Chorioamnionitis) |
16; 16 | 0.95 |
| SECONDARY Endometritis |
4; 4 | 0.98 |
| SECONDARY 1 Minute Apgar Score |
8; 7.9 | 0.95 |
| SECONDARY 5 Minute Apgar Score |
8.8; 8.8 | 0.1 |
| SECONDARY Time to Foley Bulb Extrusion of Trial of Labor After Cesarean Section |
5.6; 10.6 | 0.0003 sig |
| SECONDARY 5 Minute Apgar Score of Trial of Labor After Cesarean Section |
8.7; 8.4 | 0.48 |
Summary
The Foley catheter is a safe, effective method for cervical ripening. Limited data exists to indicate ideal time of placement for optimal cervical ripening prior to induction. The proposed study is a randomized control trial to determine if shortening placement from 12 to 6 hours of foley catheter can decrease time from start of induction to delivery. The prediction is that shortening foley bulb placement will result in shorter induction times, increased patient satisfaction and decreased length of stay on labor and delivery with secondary decreased medical costs.
Eligibility Criteria
Inclusion Criteria
- Intrauterine pregnancy at 37 weeks gestational age or greater as determined by best obstetrical dating criteria
- Singleton gestation
- Vertex presentation
- Clinically adequate pelvis
- Bishop Score less than or equal to 6
- 16 years and older
- North Carolina state law provides for the emancipation of minors, Chapter 7B-Article 35.
Exclusion Criteria
- Any maternal or fetal contraindication to vaginal delivery
- Known uterine anomaly
- Multifetal gestation
- Estimated fetal weight of 4500 gm or greater
- Ruptured membranes
Data sourced from ClinicalTrials.gov (NCT03086967). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.