Clinical trial NCT05062343: Cook Balloon vs Dilapan-S for Outpatient Cervical Ripening
Official title: Cook Balloon vs Dilapan-S for Outpatient Cervical Ripening
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Induced; Birth
Keywords: Induction of labor
Cervical ripening
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
First posted: 2021-09-30
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Controlled Trial
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in Bishop Score
timeFrame: Up to 24 hours
Secondary outcomes:
measure: Patient Satisfaction
timeFrame: Assessed upon device removal, within 24 hours
measure: Mode of Delivery: Vaginal Delivery, Cesarean Delivery
timeFrame: Assessed at the time of delivery, within 1 week
measure: Time on Labor and Delivery
timeFrame: Assessed at the time of delivery, within 1 week
measure: Maternal Length of Stay
timeFrame: Assessed at end of study period (week 4)
measure: Cervical Ripening Success Score: No Failure, Failure
timeFrame: Assessed at the time of device removal, within 24 hours
measure: Composite Maternal Morbidity: Morbidity, no Morbidity
timeFrame: Assessed at end of study period (week 4)
measure: Composite Neonatal Morbidity: Morbidity, no Morbidity
timeFrame: Assessed at end of study period (week 4)
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's HospitaL
state: Massachusetts
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.