Cook Balloon vs Dilapan-S for Outpatient Cervical Ripening

NCT05062343 | Completed Results FDA Device

• 1 other identifier: 2021P002625
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Induced; Birth

Keywords

Induction of labor; Cervical ripening

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Patient Satisfaction

  Assessed upon device removal, within 24 hours

• Mode of Delivery: Vaginal Delivery, Cesarean Delivery

  Assessed at the time of delivery, within 1 week

• Time on Labor and Delivery

  Assessed at the time of delivery, within 1 week

• Maternal Length of Stay

  Assessed at end of study period (week 4)

• Cervical Ripening Success Score: No Failure, Failure

  Assessed at the time of device removal, within 24 hours

Study Arms (2)

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.

Device: Dilapan-S

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.

Device: Cook Cervical Ripening Balloon

Interventions

Dilapan-S DEVICE

Osmotic dilator

Dilapan-S

Cook Cervical Ripening Balloon DEVICE

Double balloon catheter for cervical ripening

Also known as: Cook catheter

Cook Catheter

Eligibility Criteria

• Age: 18 Years - 50 Years
• Gender Eligibility Details: All pregnancy patients
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Prior cesarean section
• Any contraindication to outpatient cervical ripening per Brigham and Women's outpatient cervical ripening protocol
• Non-English-speaking

Sponsors & Collaborators

• Brigham and Women's Hospital: lead

Study Sites (1)

Brigham and Women's HospitaL

Boston, Massachusetts, 02115, United States

Location

Related Publications (4)

• 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.

  PMID: 30089070 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.

  PMID: 30790569 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.

  PMID: 32769658 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.

  PMID: 34222185 BACKGROUND

Results Point of Contact

• Title: Sarah Little
• Organization: Brigham and Women's Hospital

selittle@bwh.harvard.edu

6174557372

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Masking Details: Physician performing the cervical exams will be blinded to the patient's study arm
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Instructor

Model Details: Randomized Controlled Trial

Study Record Dates

• First Submitted: September 9, 2021
• First Posted: September 30, 2021
• Study Start: May 1, 2022
• Primary Completion: July 19, 2023
• Study Completion: July 19, 2023
• Last Updated: October 27, 2023
• Results First Posted: October 27, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)