Induced; Birth
Conditions
Keywords
Induction of labor, Cervical ripening
Brief 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.
Detailed description
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.
Interventions
DEVICEDilapan-S
Osmotic dilator
Double balloon catheter for cervical ripening
Sponsors
Brigham and Women's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Caregiver)
Masking description
Physician performing the cervical exams will be blinded to the patient's study arm
Intervention model description
Randomized Controlled Trial
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Bishop Score | Up to 24 hours | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mode of Delivery: Vaginal Delivery, Cesarean Delivery | Assessed at the time of delivery, within 1 week | Mode of delivery, vaginal (including spontaneous vaginal, forceps and vacuum) and cesarean delivery |
| Time on Labor and Delivery | Assessed at the time of delivery, within 1 week | Time from admission on labor and delivery until delivery. Measured in hours. |
| Maternal Length of Stay | Assessed at end of study period (week 4) | Admission Date/Time to Discharge Date/Time |
| Patient Satisfaction | Assessed upon device removal, within 24 hours | Patient Satisfaction score based on patient survey. Range from 0 (unsatisfied) to 10 (highly satisfied). |
| Composite Maternal Morbidity: Morbidity, no Morbidity | Assessed at end of study period (week 4) | Morbidity defined as any one of the following: higher-order laceration, blood transfusion, endometritis, wound infection, venous thromboembolism, hysterectomy, ICU admission or death |
| Composite Neonatal Morbidity: Morbidity, no Morbidity | Assessed at end of study period (week 4) | 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 |
| Cervical Ripening Success Score: No Failure, Failure | Assessed at the time of device removal, within 24 hours | Failure defined by: inability to place intervention agent or need for further cervical ripening after removal |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Dilapan-S 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.
Dilapan-S: Osmotic dilator | 40 |
| Cook Catheter 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.
Cook Cervical Ripening Balloon: Double balloon catheter for cervical ripening | 40 |
| Total | 80 |
Baseline characteristics
| Characteristic | Dilapan-S | Total | Cook Catheter |
|---|---|---|---|
| Age, Continuous | 31.8 years STANDARD_DEVIATION 4.8 | 32.5 years STANDARD_DEVIATION 4.5 | 33.3 years STANDARD_DEVIATION 4.1 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 5 Participants | 11 Participants | 6 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 34 Participants | 68 Participants | 34 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 0 Participants |
| Gestational age | 39.4 Weeks STANDARD_DEVIATION 1 | 39.4 Weeks STANDARD_DEVIATION 0.9 | 39.3 Weeks STANDARD_DEVIATION 0.7 |
| Insurance type: public, private Private insurance | 31 Participants | 67 Participants | 36 Participants |
| Insurance type: public, private Public insurance | 9 Participants | 13 Participants | 4 Participants |
| Parity: Nulliparity, Multiparity Multiparity | 12 Participants | 24 Participants | 12 Participants |
| Parity: Nulliparity, Multiparity Nulliparity | 28 Participants | 56 Participants | 28 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 3 Participants | 5 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 6 Participants | 8 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 4 Participants | 7 Participants | 3 Participants |
| Race (NIH/OMB) White | 27 Participants | 60 Participants | 33 Participants |
| Sex: Female, Male Female | 40 Participants | 80 Participants | 40 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 40 | 0 / 40 |
| other Total, other adverse events | 0 / 40 | 0 / 40 |
| serious Total, serious adverse events | 0 / 40 | 0 / 40 |
Outcome results
Primary
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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Dilapan-S | Change in Bishop Score | 3.0 score on a scale |
| Cook Catheter | Change in Bishop Score | 3.0 score on a scale |
p-value: 0.91Wilcoxon (Mann-Whitney)
Secondary
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
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Dilapan-S | Cervical Ripening Success Score: No Failure, Failure | No failure | 33 Participants |
| Dilapan-S | Cervical Ripening Success Score: No Failure, Failure | Failure | 7 Participants |
| Cook Catheter | Cervical Ripening Success Score: No Failure, Failure | No failure | 25 Participants |
| Cook Catheter | Cervical Ripening Success Score: No Failure, Failure | Failure | 15 Participants |
p-value: 0.045Chi-squared
Secondary
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)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Dilapan-S | Composite Maternal Morbidity: Morbidity, no Morbidity | No Morbidity | 32 Participants |
| Dilapan-S | Composite Maternal Morbidity: Morbidity, no Morbidity | Morbidity | 8 Participants |
| Cook Catheter | Composite Maternal Morbidity: Morbidity, no Morbidity | No Morbidity | 32 Participants |
| Cook Catheter | Composite Maternal Morbidity: Morbidity, no Morbidity | Morbidity | 8 Participants |
p-value: 1Chi-squared
Secondary
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)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Dilapan-S | Composite Neonatal Morbidity: Morbidity, no Morbidity | Morbidity | 1 Participants |
| Dilapan-S | Composite Neonatal Morbidity: Morbidity, no Morbidity | No morbidity | 39 Participants |
| Cook Catheter | Composite Neonatal Morbidity: Morbidity, no Morbidity | Morbidity | 0 Participants |
| Cook Catheter | Composite Neonatal Morbidity: Morbidity, no Morbidity | No morbidity | 40 Participants |
p-value: 1Fisher Exact
Secondary
Maternal Length of Stay
Admission Date/Time to Discharge Date/Time
Time frame: Assessed at end of study period (week 4)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Dilapan-S | Maternal Length of Stay | 3.2 Days |
| Cook Catheter | Maternal Length of Stay | 2.9 Days |
p-value: 0.98Wilcoxon (Mann-Whitney)
Secondary
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
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Dilapan-S | Mode of Delivery: Vaginal Delivery, Cesarean Delivery | Vaginal delivery | 30 Participants |
| Dilapan-S | Mode of Delivery: Vaginal Delivery, Cesarean Delivery | Cesarean delivery | 10 Participants |
| Cook Catheter | Mode of Delivery: Vaginal Delivery, Cesarean Delivery | Vaginal delivery | 30 Participants |
| Cook Catheter | Mode of Delivery: Vaginal Delivery, Cesarean Delivery | Cesarean delivery | 10 Participants |
p-value: 1Chi-squared
Secondary
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
Population: 3 participants did not fill out the survey and were not included in this outcome measure analysis.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Dilapan-S | Patient Satisfaction | 9 score on a scale |
| Cook Catheter | Patient Satisfaction | 8 score on a scale |
p-value: <0.01Wilcoxon (Mann-Whitney)
Secondary
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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Dilapan-S | Time on Labor and Delivery | 20.1 Hours |
| Cook Catheter | Time on Labor and Delivery | 17.0 Hours |
p-value: 0.89Wilcoxon (Mann-Whitney)