Comparison of Two Mechanical Methods of Outpatient Ripening of the Cervix

NCT03752073 | Terminated DMC FDA Device

• 1 other identifier: STUDY00000397
• Study Type: interventional
• Target: 185
• Locations: 1 country
• Sites: 2

Brief Summary

This is a randomized prospective trial of two mechanical methods of pre-induction cervical ripening agents.

Conditions

Induction of Labor

Outcome Measures

Primary Outcomes (1)

• Time from start of cervical ripening to delivery

  Time in minutes from placement of cervical ripening agent to delivery

  720-2160 minutes

Secondary Outcomes (3)

• Pain of insertion

  First hour

• Pain over duration of cervical ripening

  12-14 hours

• Patient satisfaction with cervical ripening agent

  24-36 hours

Other Outcomes (12)

• Rate of device expulsion prior to admission

  12-14 hours

• Rate of onset of labor prior to planned admission

  12-14 hours

• Rate of cesarean delivery

  12-36 hours

Study Arms (2)

Trans-cervical cervical balloon

EXPERIMENTAL

17 F non-latex Foley catheter will be placed and balloon filled with 30 cc of sterile normal saline.

Device: Trans-cervical cervical balloon

Hygroscopic cervical dilators

EXPERIMENTAL

Dilapan-S hygroscopic dilators will be placed into the cervix at the level of the internal os.

Device: Hygroscopic cervical dilator

Interventions

Trans-cervical cervical balloon DEVICE

Insertion of Foley Catheter

Trans-cervical cervical balloon

Hygroscopic cervical dilator DEVICE

Insertion of Dilapan-s

Hygroscopic cervical dilators

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Women between 39 and 41 weeks gestational age who desire elective induction of labor, based on reliable estimated gestational age (defined as ultrasonography performed before 14 weeks 0 days, or a certain last menstrual period consistent with ultrasonography performed before 21 weeks 0 days).

You may not qualify if:

• \. Risk factors for placental insufficiency or intra-partum complication such as intra-uterine growth restriction, hypertensive disease, diabetes requiring insulin therapy, multiple gestation, history of previous hysterotomy, cholestasis of pregnancy, placental abnormalities including low lying placenta (\< 2 cm from cervical os), maternal cardiac disease, maternal pulmonary disease, known fetal anomaly, fetal demise, etc.
• \. Simplified Bishop score must be \<6 and cervical dilation \<2 cm.
• \. Women must be able to give informed consent.
• \. Concern regarding fetal well-being, conditions which preclude vaginal birth, group B strep carriers, patients who are HIV, Hep B or Hep C positive.
• \. Women allergic to povidone-iodine, aquacryl hydrogel or the latex-free Foley catheter.

Sponsors & Collaborators

• Ochsner Health System: lead
• Northwell Health: collaborator

Study Sites (2)

Ochsner Baptist Hospital

New Orleans, Louisiana, 70115, United States

Location

Brigid McCue

Bay Shore, New York, 11706, United States

Location

Related Publications (7)

• Sciscione AC, Muench M, Pollock M, Jenkins TM, Tildon-Burton J, Colmorgen GH. Transcervical Foley catheter for preinduction cervical ripening in an outpatient versus inpatient setting. Obstet Gynecol. 2001 Nov;98(5 Pt 1):751-6. doi: 10.1016/s0029-7844(01)01579-4.

  PMID: 11704164 BACKGROUND

• Sciscione AC, Bedder CL, Hoffman MK, Ruhstaller K, Shlossman PA. The timing of adverse events with Foley catheter preinduction cervical ripening; implications for outpatient use. Am J Perinatol. 2014 Oct;31(9):781-6. doi: 10.1055/s-0033-1359718. Epub 2013 Dec 17.

  PMID: 24347259 BACKGROUND

• Gilson GJ, Russell DJ, Izquierdo LA, Qualls CR, Curet LB. A prospective randomized evaluation of a hygroscopic cervical dilator, Dilapan, in the preinduction ripening of patients undergoing induction of labor. Am J Obstet Gynecol. 1996 Jul;175(1):145-9. doi: 10.1016/s0002-9378(96)70264-8.

  PMID: 8694040 BACKGROUND

• Shindo R, Aoki S, Yonemoto N, Yamamoto Y, Kasai J, Kasai M, Miyagi E. Hygroscopic dilators vs balloon catheter ripening of the cervix for induction of labor in nulliparous women at term: Retrospective study. PLoS One. 2017 Dec 22;12(12):e0189665. doi: 10.1371/journal.pone.0189665. eCollection 2017.

  PMID: 29272277 BACKGROUND

• Kuper SG, Jauk VC, George DM, Edwards RK, Szychowski JM, Mazzoni SE, Wang MJ, Files P, Tita AT, Subramaniam A, Harper LM. Outpatient Foley Catheter for Induction of Labor in Parous Women: A Randomized Controlled Trial. Obstet Gynecol. 2018 Jul;132(1):94-101. doi: 10.1097/AOG.0000000000002678.

  PMID: 29889751 RESULT

• Lu AMR, Lin B, Shahani D, Demertzis K, Muscat J, Zabel E, Olson P, Manayan O, Nonnamaker E, Fest J, McCue B. Randomized control trial comparing hygroscopic cervical dilators to cervical ripening balloon for outpatient cervical ripening. Am J Obstet Gynecol MFM. 2024 Apr;6(4):101318. doi: 10.1016/j.ajogmf.2024.101318. Epub 2024 Feb 28.

  PMID: 38417552 DERIVED

• de Vaan MD, Ten Eikelder ML, Jozwiak M, Palmer KR, Davies-Tuck M, Bloemenkamp KW, Mol BWJ, Boulvain M. Mechanical methods for induction of labour. Cochrane Database Syst Rev. 2023 Mar 30;3(3):CD001233. doi: 10.1002/14651858.CD001233.pub4.

  PMID: 36996264 DERIVED

Study Officials

• Brigid McCue, MD

  Northwell Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 4, 2018
• First Posted: November 23, 2018
• Study Start: March 1, 2019
• Primary Completion: January 1, 2023
• Study Completion: January 1, 2023
• Last Updated: April 25, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)