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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dilapan-S | Active Comparator | 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. |
|
| Cook Catheter | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dilapan-S | Device | Osmotic dilator |
| |
| Cook Cervical Ripening Balloon |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Satisfaction | Patient Satisfaction score based on patient survey. Range from 0 (unsatisfied) to 10 (highly satisfied). | Assessed upon device removal, within 24 hours |
| Mode of Delivery: Vaginal Delivery, Cesarean Delivery |
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Inclusion Criteria:
Exclusion Criteria:
All pregnancy patients
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brigham and Women's HospitaL | Boston | Massachusetts | 02115 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30089070 | Background | Grobman WA, Rice MM, Reddy UM, Tita ATN, Silver RM, Mallett G, Hill K, Thom EA, El-Sayed YY, Perez-Delboy A, Rouse DJ, Saade GR, Boggess KA, Chauhan SP, Iams JD, Chien EK, Casey BM, Gibbs RS, Srinivas SK, Swamy GK, Simhan HN, Macones GA; Eunice Kennedy Shriver National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network. Labor Induction versus Expectant Management in Low-Risk Nulliparous Women. N Engl J Med. 2018 Aug 9;379(6):513-523. doi: 10.1056/NEJMoa1800566. | |
| 30790569 |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Median | Inter-Quartile Range | score on a scale | Up to 24 hours |
|
Events collected up until 6 weeks after delivery
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sarah Little | Brigham and Women's Hospital | 6174557372 | selittle@bwh.harvard.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 24, 2022 | Oct 2, 2023 | Prot_SAP_000.pdf |
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Randomized Controlled Trial
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Physician performing the cervical exams will be blinded to the patient's study arm
| Device |
Double balloon catheter for cervical ripening |
|
|
Mode of delivery, vaginal (including spontaneous vaginal, forceps and vacuum) and cesarean delivery
| 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. | Assessed at the time of delivery, within 1 week |
| Maternal Length of Stay | Admission Date/Time to Discharge Date/Time | 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 | 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 | 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 | Assessed at end of study period (week 4) |
| Background |
| Saad AF, Villarreal J, Eid J, Spencer N, Ellis V, Hankins GD, Saade GR. A randomized controlled trial of Dilapan-S vs Foley balloon for preinduction cervical ripening (DILAFOL trial). Am J Obstet Gynecol. 2019 Mar;220(3):275.e1-275.e9. doi: 10.1016/j.ajog.2019.01.008. Epub 2019 Feb 18. |
| 32769658 | Background | Ausbeck EB, Jauk VC, Xue Y, Files P, Kuper SG, Subramaniam A, Casey BM, Szychowski JM, Harper LM, Tita AT. Outpatient Foley Catheter for Induction of Labor in Nulliparous Women: A Randomized Controlled Trial. Obstet Gynecol. 2020 Sep;136(3):597-606. doi: 10.1097/AOG.0000000000004041. |
| 34222185 | Background | Saunders SJ, Saunders R, Wong T, Saad AF. Out-of-Hospital Cervical Ripening With a Synthetic Hygroscopic Cervical Dilator May Reduce Hospital Costs and Cesarean Sections in the United States-A Cost-Consequence Analysis. Front Public Health. 2021 Jun 18;9:689115. doi: 10.3389/fpubh.2021.689115. eCollection 2021. |
| BG001 | 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 |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Gestational age | Mean | Standard Deviation | Weeks |
|
| Parity: Nulliparity, Multiparity | Number of participants without a prior delivery (nulliparity) and with 1 more deliveries (multiparity) | Count of Participants | Participants |
|
| Insurance type: public, private | Count of Participants | Participants |
|
| OG001 | 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 |
|
|
|
| Secondary | Patient Satisfaction | Patient Satisfaction score based on patient survey. Range from 0 (unsatisfied) to 10 (highly satisfied). | 3 participants did not fill out the survey and were not included in this outcome measure analysis. | Posted | Median | Inter-Quartile Range | score on a scale | Assessed upon device removal, within 24 hours |
|
|
|
|
| Secondary | Mode of Delivery: Vaginal Delivery, Cesarean Delivery | Mode of delivery, vaginal (including spontaneous vaginal, forceps and vacuum) and cesarean delivery | Posted | Count of Participants | Participants | Assessed at the time of delivery, within 1 week |
|
|
|
|
| Secondary | Time on Labor and Delivery | Time from admission on labor and delivery until delivery. Measured in hours. | Posted | Median | Inter-Quartile Range | Hours | Assessed at the time of delivery, within 1 week |
|
|
|
|
| Secondary | Maternal Length of Stay | Admission Date/Time to Discharge Date/Time | Posted | Median | Inter-Quartile Range | Days | Assessed at end of study period (week 4) |
|
|
|
|
| Secondary | Cervical Ripening Success Score: No Failure, Failure | Failure defined by: inability to place intervention agent or need for further cervical ripening after removal | Posted | Count of Participants | Participants | Assessed at the time of device removal, within 24 hours |
|
|
|
|
| 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 | Posted | Count of Participants | Participants | Assessed at end of study period (week 4) |
|
|
|
|
| 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 | Posted | Count of Participants | Participants | Assessed at end of study period (week 4) |
|
|
|
|
| 0 |
| 40 |
| 0 |
| 40 |
| 0 |
| 40 |
| EG001 | 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 | 0 | 40 | 0 | 40 | 0 | 40 |
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