N/A
N=178
Length of Cook Catheter Placement and Induction of Labor
Induction of Labor
Bottom Line
View on ClinicalTrials.gov: NCT04233008 ↗Enrolled (actual)
178
Serious AEs
0.0%
Results posted
Jun 2022
Primary outcome: Primary: Time to Delivery — 19.2; 24.3 hours — p=0.04
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Foley catheter length (Device)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Brigham and Women's Hospital
- Primary completion
- Jul 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to Delivery |
19.2; 24.3 | 0.04 sig |
| SECONDARY Cesarean Delivery Rate |
17; 25 | 0.14 |
| SECONDARY Time to Active Labor |
10.5; 15.9 | <0.01 sig |
| SECONDARY Delivery Within 12 Hours |
14; 9 | 0.39 |
| SECONDARY Delivery Within 24 Hours |
60; 42 | <0.01 sig |
| SECONDARY Maternal Length of Stay |
2; 2 | — |
| SECONDARY Indication for Cesarean Delivery |
10; 11 | 0.8 |
| SECONDARY Maternal Complications |
7; 8; 7; 2; 1; 1 | — |
| SECONDARY Neonatal Complications |
0; 0 | — |
| SECONDARY NICU Admission |
9; 6 | — |
| SECONDARY NICU Admission >48 Hours |
4; 2 | — |
| SECONDARY Neonatal Length of Stay |
2; 2 | — |
Summary
The goal of this study is to compare cook catheter placement for 6 vs. 12 hours to see if there is faster time to delivery for people admitted to labor and delivery undergoing induction of labor.
Eligibility Criteria
Inclusion Criteria: Women undergoing cervical ripening for labor induction at term (37-41 6/7 weeks) with a singleton gestation in cephalic presentation. Women will need to have a bishop score <6 or cervical dilation <2cm with intact membranes to be included.
Exclusion Criteria
- Non English speaking
- Contraindications to vaginal delivery
- Prior cesarean section
Data sourced from ClinicalTrials.gov (NCT04233008). 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.