Cook Balloon vs Dilapan-S for Outpatient Cervical Ripening

Induced; Birth Clinical Trial

Official title:

Cook Balloon vs Dilapan-S for Outpatient Cervical Ripening

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05062343
• Other study ID #: 2021P002625
• Status: Completed
• Phase: N/A
• Start date: May 1, 2022
• Est. completion date: July 19, 2023

Study information

• Verified date: October 2023
• Source: Brigham and Women's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: July 19, 2023
• Est. primary completion date: July 19, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Induced; Birth

Intervention

Device:
• Dilapan-S
Osmotic dilator
• Cook Cervical Ripening Balloon
Double balloon catheter for cervical ripening

Locations

Country	Name	City	State
United States	Brigham and Women's HospitaL	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Brigham and Women's Hospital

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	Up to 24 hours
Secondary	Patient Satisfaction	Patient Satisfaction score based on patient survey. Range from 0 (unsatisfied) to 10 (highly satisfied).	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	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.	Assessed at the time of delivery, within 1 week
Secondary	Maternal Length of Stay	Admission Date/Time to Discharge Date/Time	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	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	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	Assessed at end of study period (week 4)