Trial Outcomes & Findings for Cook Balloon vs Dilapan-S for Outpatient Cervical Ripening (NCT NCT05062343)

Last Updated: 2023-10-27

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

80 participants

Primary outcome timeframe

Up to 24 hours

Results posted on

2023-10-27

Participant Flow

Participant milestones

Participant milestones
Measure	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	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
Overall Study STARTED	40	40
Overall Study COMPLETED	40	40
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Cook Balloon vs Dilapan-S for Outpatient Cervical Ripening

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Dilapan-S n=40 Participants 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	Cook Catheter n=40 Participants 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	Total n=80 Participants Total of all reporting groups
Age, Continuous	31.8 years STANDARD_DEVIATION 4.8 • n=5 Participants	33.3 years STANDARD_DEVIATION 4.1 • n=7 Participants	32.5 years STANDARD_DEVIATION 4.5 • n=5 Participants
Sex: Female, Male Female	40 Participants n=5 Participants	40 Participants n=7 Participants	80 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	5 Participants n=5 Participants	6 Participants n=7 Participants	11 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	34 Participants n=5 Participants	34 Participants n=7 Participants	68 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	6 Participants n=5 Participants	2 Participants n=7 Participants	8 Participants n=5 Participants
Race (NIH/OMB) White	27 Participants n=5 Participants	33 Participants n=7 Participants	60 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	4 Participants n=5 Participants	3 Participants n=7 Participants	7 Participants n=5 Participants
Gestational age	39.4 Weeks STANDARD_DEVIATION 1.0 • n=5 Participants	39.3 Weeks STANDARD_DEVIATION 0.7 • n=7 Participants	39.4 Weeks STANDARD_DEVIATION 0.9 • n=5 Participants
Parity: Nulliparity, Multiparity Nulliparity	28 Participants n=5 Participants	28 Participants n=7 Participants	56 Participants n=5 Participants
Parity: Nulliparity, Multiparity Multiparity	12 Participants n=5 Participants	12 Participants n=7 Participants	24 Participants n=5 Participants
Insurance type: public, private Public insurance	9 Participants n=5 Participants	4 Participants n=7 Participants	13 Participants n=5 Participants
Insurance type: public, private Private insurance	31 Participants n=5 Participants	36 Participants n=7 Participants	67 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 24 hours

Outcome measures

Outcome measures
Measure	Dilapan-S n=40 Participants 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	Cook Catheter n=40 Participants 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
Change in Bishop Score	3.0 score on a scale Interval 2.0 to 5.0	3.0 score on a scale Interval 2.0 to 4.5

SECONDARY outcome

Timeframe: 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.

Patient Satisfaction score based on patient survey. Range from 0 (unsatisfied) to 10 (highly satisfied).

Outcome measures

Outcome measures
Measure	Dilapan-S n=38 Participants 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	Cook Catheter n=39 Participants 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
Patient Satisfaction	9 score on a scale Interval 8.0 to 10.0	8 score on a scale Interval 5.0 to 9.0

SECONDARY outcome

Timeframe: Assessed at the time of delivery, within 1 week

Mode of delivery, vaginal (including spontaneous vaginal, forceps and vacuum) and cesarean delivery

Outcome measures

Outcome measures
Measure	Dilapan-S n=40 Participants 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	Cook Catheter n=40 Participants 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
Mode of Delivery: Vaginal Delivery, Cesarean Delivery Vaginal delivery	30 Participants	30 Participants
Mode of Delivery: Vaginal Delivery, Cesarean Delivery Cesarean delivery	10 Participants	10 Participants

SECONDARY outcome

Timeframe: Assessed at the time of delivery, within 1 week

Time from admission on labor and delivery until delivery. Measured in hours.

Outcome measures

Outcome measures
Measure	Dilapan-S n=40 Participants 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	Cook Catheter n=40 Participants 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
Time on Labor and Delivery	20.1 Hours Interval 13.9 to 26.2	17.0 Hours Interval 11.7 to 28.4

SECONDARY outcome

Timeframe: Assessed at end of study period (week 4)

Admission Date/Time to Discharge Date/Time

Outcome measures

Outcome measures
Measure	Dilapan-S n=40 Participants 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	Cook Catheter n=40 Participants 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
Maternal Length of Stay	3.2 Days Interval 2.7 to 4.7	2.9 Days Interval 2.7 to 3.9

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Dilapan-S n=40 Participants 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	Cook Catheter n=40 Participants 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
Cervical Ripening Success Score: No Failure, Failure No failure	33 Participants	25 Participants
Cervical Ripening Success Score: No Failure, Failure Failure	7 Participants	15 Participants

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Dilapan-S n=40 Participants 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	Cook Catheter n=40 Participants 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
Composite Maternal Morbidity: Morbidity, no Morbidity Morbidity	8 Participants	8 Participants
Composite Maternal Morbidity: Morbidity, no Morbidity No Morbidity	32 Participants	32 Participants

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Dilapan-S n=40 Participants 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	Cook Catheter n=40 Participants 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
Composite Neonatal Morbidity: Morbidity, no Morbidity Morbidity	1 Participants	0 Participants
Composite Neonatal Morbidity: Morbidity, no Morbidity No morbidity	39 Participants	40 Participants

Adverse Events

Dilapan-S

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Cook Catheter

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Sarah Little

Brigham and Women's Hospital

Phone: 6174557372

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place