N/A
N=197
Foley Bulb Traction for Cervical Ripening
Cervical Ripening · Induction of Labor
Bottom Line
View on ClinicalTrials.gov: NCT00976703 ↗Enrolled (actual)
197
Serious AEs
0.0%
Results posted
Jun 2013
Primary outcome: Primary: Time to Delivery — 19.8; 18.8 hours
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- weighted bag (Other); leg taping (Other)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- MetroHealth Medical Center
- Primary completion
- Jul 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to Delivery |
19.8; 18.8 | — |
| SECONDARY Patient Pain/Comfort Rating |
5; 5 | — |
| SECONDARY Time to Foley Expulsion |
1.5; 2.6 | — |
Summary
This study aims to determine what type of traction, weighted bag or inner thigh taping, on foley catheters for cervical ripening results in a greater cervical dilation and shorter length of labor.
The primary outcomes are post-ripening dilation of 3 cm or more and time to delivery.
The secondary outcomes are patient pain/comfort rating and method of delivery. The investigators hypothesize that the use a weighted bag will result in a 20% increase in post-ripening dilation of at least 3 cm and a shorter average length of labor.
Eligibility Criteria
Inclusion Criteria
- Single viable intrauterine pregnancy
- Cephalic presentation
- Bishop score 6
- Spontaneous labor/regular contractions on admission
- Rupture of membranes
- Previous uterine scar
- Grandmultiparity (greater than 5 deliveries)
Data sourced from ClinicalTrials.gov (NCT00976703). 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.