An interventional study of Dilapan-S and Cook Cervical Ripening Balloon in Induced; Birth, sponsored by Brigham and Women's Hospital. Completed at 1 site in United States. Open to female participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2023-10-27.
Sponsored by Brigham and Women's Hospital · Not applicable, Interventional, and Treatment
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.
Upon presentation for cervical ripening appointment, a sterile vaginal exam will be completed to assign Bishop score, as per standard routine. Once the patient has been consented and randomized, the participant will have a Cook catheter or Dilapan-S inserted. For the Cook catheter, the uterine component of the balloon will be inflated to maximum 60mL, the vaginal balloon will not be inflated per standard practice and per the literature that shows slightly increased pain and negligible improvement in cervical ripening. The catheter will be taped to the inner thigh with gentle traction. For Dilapan-S, 3-5 dilators will be placed.
After placement, the patient will be discharged home with strict return precautions per the outpatient cervical ripening protocol. Patients must return to labor and delivery within 24 hours of cervical ripening agent placement at their scheduled inpatient induction time.
Upon return to labor and delivery, if not already expelled, the mechanical ripening device will be removed, and an examiner blinded to the cervical ripening method will complete a sterile vaginal exam to assign a Bishop score.
At that point health care providers will manage active labor per usual practice. Labor interventions are at the discretion of the healthcare provider. The need for operative delivery or cesarean section will be at the discretion of the healthcare provider.
Brigham and Women's Hospital is the lead sponsor of 1,236 studies on the registry; 224 are open to participants now.
Of its 116 completed or terminated interventional studies of FDA-regulated products, 64 (55%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
After randomization, the patient will have Dilapan-S placed via sterile speculum exam with placement of 3-5 rods. The rods will remain in place until expelled or up to 24 hours or until the scheduled return to labor and delivery. At presentation to labor and delivery, the rods will be confirmed expelled or will be removed and a blinded examiner will complete a sterile cervical exam. At that point the primary health care providers will manage further labor per their standard practice.
Device: Dilapan-S
After randomization, the patient will have the Cook catheter placed via sterile vaginal or speculum exam with the uterine component of the balloon inflated to maximum 60mL. The balloon will remain in place until expelled or up to 24 hours or until the scheduled return to labor and delivery. At presentation to labor and delivery, the Cook catheter will be confirmed expelled or will be removed and a blinded examiner will complete a sterile cervical exam. At that point the primary health care providers will manage further labor per their standard practice.
Device: Cook Cervical Ripening Balloon
Osmotic dilator
Double balloon catheter for cervical ripening
Also known as: Cook catheter
Change in Bishop Score
Difference in Bishop score calculated from exam at time of device removal minus Bishop score calculated from exam at time of device placement. Bishop score, or cervical score, ranges from a minimum of 0 to maximum of 13. Higher scores indicate that the cervix is more favorable, or ready for labor. Thus, change in Bishop score could range from -13 to +13 with a higher number showing more change in the score, or more cervical ripening.
Time frame: Up to 24 hours
Patient Satisfaction
Patient Satisfaction score based on patient survey. Range from 0 (unsatisfied) to 10 (highly satisfied).
Time frame: Assessed upon device removal, within 24 hours
Mode of Delivery: Vaginal Delivery, Cesarean Delivery
Mode of delivery, vaginal (including spontaneous vaginal, forceps and vacuum) and cesarean delivery
Time frame: Assessed at the time of delivery, within 1 week
Time on Labor and Delivery
Time from admission on labor and delivery until delivery. Measured in hours.
Time frame: Assessed at the time of delivery, within 1 week
Maternal Length of Stay
Admission Date/Time to Discharge Date/Time
Time frame: Assessed at end of study period (week 4)
Cervical Ripening Success Score: No Failure, Failure
Failure defined by: inability to place intervention agent or need for further cervical ripening after removal
Time frame: Assessed at the time of device removal, within 24 hours
Composite Maternal Morbidity: Morbidity, no Morbidity
Morbidity defined as any one of the following: higher-order laceration, blood transfusion, endometritis, wound infection, venous thromboembolism, hysterectomy, ICU admission or death
Time frame: Assessed at end of study period (week 4)
Composite Neonatal Morbidity: Morbidity, no Morbidity
Morbidity defined as any one of the following: culture-proven neonatal sepsis, neonatal blood transfusion, hypoxic-ischemic encephalopathy, intraventricular hemorrhage grade 3 or 4, or therapeutic hypothermia
Time frame: Assessed at end of study period (week 4)
| Milestone | Dilapan-S | Cook Catheter |
|---|---|---|
| Started | 40 | 40 |
| Completed | 40 | 40 |
| Not completed | 0 | 0 |
Difference in Bishop score calculated from exam at time of device removal minus Bishop score calculated from exam at time of device placement. Bishop score, or cervical score, ranges from a minimum of 0 to maximum of 13. Higher scores indicate that the cervix is more favorable, or ready for labor. Thus, change in Bishop score could range from -13 to +13 with a higher number showing more change in the score, or more cervical ripening.
| score on a scale | Dilapan-S | Cook Catheter |
|---|---|---|
| Change in Bishop Score | 3.0 (2.0 to 5.0) | 3.0 (2.0 to 4.5) |
Patient Satisfaction score based on patient survey. Range from 0 (unsatisfied) to 10 (highly satisfied).
| score on a scale | Dilapan-S | Cook Catheter |
|---|---|---|
| Patient Satisfaction | 9 (8 to 10) | 8 (5 to 9) |
Mode of delivery, vaginal (including spontaneous vaginal, forceps and vacuum) and cesarean delivery
| Participants | Dilapan-S | Cook Catheter |
|---|---|---|
| Vaginal delivery | 30 | 30 |
| Cesarean delivery | 10 | 10 |
Time from admission on labor and delivery until delivery. Measured in hours.
| Hours | Dilapan-S | Cook Catheter |
|---|---|---|
| Time on Labor and Delivery | 20.1 (13.9 to 26.2) | 17.0 (11.7 to 28.4) |
Admission Date/Time to Discharge Date/Time
| Days | Dilapan-S | Cook Catheter |
|---|---|---|
| Maternal Length of Stay | 3.2 (2.7 to 4.7) | 2.9 (2.7 to 3.9) |
Failure defined by: inability to place intervention agent or need for further cervical ripening after removal
| Participants | Dilapan-S | Cook Catheter |
|---|---|---|
| No failure | 33 | 25 |
| Failure | 7 | 15 |
Morbidity defined as any one of the following: higher-order laceration, blood transfusion, endometritis, wound infection, venous thromboembolism, hysterectomy, ICU admission or death
| Participants | Dilapan-S | Cook Catheter |
|---|---|---|
| Morbidity | 8 | 8 |
| No Morbidity | 32 | 32 |
Morbidity defined as any one of the following: culture-proven neonatal sepsis, neonatal blood transfusion, hypoxic-ischemic encephalopathy, intraventricular hemorrhage grade 3 or 4, or therapeutic hypothermia
| Participants | Dilapan-S | Cook Catheter |
|---|---|---|
| Morbidity | 1 | 0 |
| No morbidity | 39 | 40 |
Collected over Events collected up until 6 weeks after delivery. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Dilapan-S | 0/40 (0%) | 0/40 (0%) | 0/40 (0%) |
| Cook Catheter | 0/40 (0%) | 0/40 (0%) | 0/40 (0%) |
| Age, Continuous(years) | Dilapan-S | Cook Catheter | Total |
|---|---|---|---|
| Mean | 31.8 ± 4.8 | 33.3 ± 4.1 | 32.5 ± 4.5 |
| Sex: Female, Male(Participants) | Dilapan-S | Cook Catheter | Total |
|---|---|---|---|
| Female | 40 | 40 | 80 |
| Male | 0 | 0 | 0 |
| Ethnicity (NIH/OMB)(Participants) | Dilapan-S | Cook Catheter | Total |
|---|---|---|---|
| Hispanic or Latino | 5 | 6 | 11 |
| Not Hispanic or Latino | 34 | 34 | 68 |
| Unknown or Not Reported | 1 | 0 | 1 |
| Race (NIH/OMB)(Participants) | Dilapan-S | Cook Catheter | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 3 | 2 | 5 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 6 | 2 | 8 |
| White | 27 | 33 | 60 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 4 | 3 | 7 |
| Gestational age(Weeks) | Dilapan-S | Cook Catheter | Total |
|---|---|---|---|
| Mean | 39.4 ± 1.0 | 39.3 ± 0.7 | 39.4 ± 0.9 |
| Parity: Nulliparity, Multiparity(Participants) | Dilapan-S | Cook Catheter | Total |
|---|---|---|---|
| Nulliparity | 28 | 28 | 56 |
| Multiparity | 12 | 12 | 24 |
| Insurance type: public, private(Participants) | Dilapan-S | Cook Catheter | Total |
|---|---|---|---|
| Public insurance | 9 | 4 | 13 |
| Private insurance | 31 | 36 | 67 |
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