N/A
N=80
Cook Balloon vs Dilapan-S for Outpatient Cervical Ripening
Induced; Birth
Bottom Line
View on ClinicalTrials.gov: NCT05062343 ↗Enrolled (actual)
80
Serious AEs
0.0%
Results posted
Oct 2023
Primary outcome: Primary: Change in Bishop Score — 3.0; 3.0 score on a scale — p=0.91
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Dilapan-S (Device); Cook Cervical Ripening Balloon (Device)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Brigham and Women's Hospital
- Primary completion
- Jul 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Bishop Score |
3.0; 3.0 | 0.91 |
| SECONDARY Patient Satisfaction |
9; 8 | <0.01 sig |
| SECONDARY Mode of Delivery: Vaginal Delivery, Cesarean Delivery |
30; 30; 10; 10 | 1.0 |
| SECONDARY Time on Labor and Delivery |
20.1; 17.0 | 0.89 |
| SECONDARY Maternal Length of Stay |
3.2; 2.9 | 0.98 |
| SECONDARY Cervical Ripening Success Score: No Failure, Failure |
33; 25; 7; 15 | 0.045 sig |
| SECONDARY Composite Maternal Morbidity: Morbidity, no Morbidity |
8; 8; 32; 32 | 1 |
| SECONDARY Composite Neonatal Morbidity: Morbidity, no Morbidity |
1; 0; 39; 40 | 1 |
Summary
The goal of this study is to compare Cook balloon and Dilapan-S for outpatient cervical ripening to see if Dilapan-S is non-inferior in increasing Bishop score compared to the Cook balloon.
Eligibility Criteria
Inclusion Criteria
- 18-50 years of age
- Term (37-41 6/7 weeks gestational age)
- Low risk (i.e. without any maternal or fetal co-morbidity) and who are candidates for outpatient cervical ripening per the Brigham and Women's outpatient cervical ripening protocol
- Singleton pregnancy
- Cephalic presentation
Exclusion Criteria
- Prior cesarean section
- Any contraindication to outpatient cervical ripening per Brigham and Women's outpatient cervical ripening protocol
- Non-English-speaking
Data sourced from ClinicalTrials.gov (NCT05062343). 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.