RCT of Cervical Ripening Double Ballon Catheter Prior to Dilation and Evacuation.

NCT07200115 | Recruiting FDA Device

• 1 other identifier: 2000040146
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine whether the overnight use of an FDA-cleared CRDB catheter is superior to the use of overnight osmotic dilators as is standard of care cervical preparation for patients presenting for dilation and evacuation (D\&E). The CRDB catheter is an FDA cleared device for cervical dilation prior to labor induction at term. It has not been FDA cleared for cervical dilation in the second-trimester, however, will be used in a similar fashion to labor inductions at term. Our standard of care osmotic dilators (e.g., laminaria, Dilapan-S) are both FDA cleared for cervical dilation prior to labor induction at term or gynecologic procedures requiring cervical dilation.

Conditions

Cervical Preparation Prior to Dilation and Evacuation

Keywords

cervical preparation; osmotic dilators; cervical ripening double balloon catheter; dilation and evacuation

Outcome Measures

Primary Outcomes (1)

• Mean Cervical Dilation

  Cervical dilation will be measured in centimeters.

  Day 1 (cervical preparation visit) to Day 2 (D&E)

Secondary Outcomes (2)

• Need for Mechanical Dilation at the Time of Procedural Abortion

  Day 2 (D&E)

• Mean Total Procedure Time

  Day 2 (D&E)

Study Arms (2)

Cervical Ripening Double Balloon (CRDB) Catheter

EXPERIMENTAL

Device: Cervical Ripening Double Balloon (CRDB) Catheter

Osmotic Dilators

ACTIVE COMPARATOR

Device: Osmotic Dilators

Interventions

Cervical Ripening Double Balloon (CRDB) Catheter DEVICE

The physician will place a CRDB catheter for overnight cervical preparation. The CRDB catheter is comprised of two balloons that can be inflated with up to 80 mL of sterile water.

Cervical Ripening Double Balloon (CRDB) Catheter

Osmotic Dilators DEVICE

Osmotic dilators (e.g., laminaria and Dilapan-S) are mechanical dilators that are placed in the cervix prior to gynecologic procedures and facilitate dilation through the slow absorption of moisture. The physician will place osmotic dilators in the standard fashion.

Osmotic Dilators

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Singleton pregnancy between 19 weeks 0 days to 23 weeks 6 days GD.
• Planning to undergo D\&E with Yale Family Planning and has undergone standard informed clinical consent counseling for the procedure and signed the clinical procedure consent form.
• Stated willingness to comply with all study procedures and availability for the duration of the active part of the study.
• English- or Spanish-speaking individual.
• Residents of the state of Connecticut.

You may not qualify if:

• Spontaneous or induced fetal demise.
• Multiple pregnancy.
• Preterm prelabor rupture of membranes (PPROM).
• Intraamniotic infection.
• Active genital tract infection.
• Active vaginal bleeding.
• Placenta previa or vasa previa.
• Placenta accreta spectrum.
• History of \>3 cesarean deliveries.
• BMI \>45 kg/m2.
• Contraindication to osmotic cervical dilator or CRDB catheter use as determined by the physician.
• Contraindication to medication used during standard of care cervical preparation.

Sponsors & Collaborators

• Yale University: lead

Study Sites (1)

Yale Family Planning Clinic

New Haven, Connecticut, 06519, United States

RECRUITING

Related Publications (19)

• Atad J, Hallak M, Auslender R, Porat-Packer T, Zarfati D, Abramovici H. A randomized comparison of prostaglandin E2, oxytocin, and the double-balloon device in inducing labor. Obstet Gynecol. 1996 Feb;87(2):223-7. doi: 10.1016/0029-7844(95)00389-4.

  PMID: 8559528 BACKGROUND

• Cook Medical. Cook Cervical Ripening Balloon with Stylet.

  BACKGROUND

• Harris PA, Taylor R, Thielke R, Payne J, Gonzalez N, Conde JG. Research electronic data capture (REDCap)--a metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed Inform. 2009 Apr;42(2):377-81. doi: 10.1016/j.jbi.2008.08.010. Epub 2008 Sep 30.

  PMID: 18929686 BACKGROUND

• Liu SM, Henkel A, Meza P, Shorter JM, Cahill E, Blumenthal PD, Shaw KA. Comparing transcervical balloon with osmotic dilators for cervical preparation prior to procedural abortion: A noninferiority randomized trial. Contraception. 2024 Dec;140:110550. doi: 10.1016/j.contraception.2024.110550. Epub 2024 Jul 25.

  PMID: 39067560 BACKGROUND

• Ornat L, Alonso-Ventura V, Bueno-Notivol J, Chedraui P, Perez-Lopez FR; Health Outcomes and Systematic Analyses (HOUSSAY) Research Group. Misoprostol combined with cervical single or double balloon catheters versus misoprostol alone for labor induction of singleton pregnancies: a meta-analysis of randomized trials. J Matern Fetal Neonatal Med. 2020 Oct;33(20):3453-3468. doi: 10.1080/14767058.2019.1574741. Epub 2019 Feb 10.

  PMID: 30741051 BACKGROUND

• Solt I, Frank Wolf M, Ben-Haroush S, Kaminskyi S, Ophir E, Bornstein J. Foley catheter versus cervical double balloon for labor induction: a prospective randomized study. J Matern Fetal Neonatal Med. 2021 Apr;34(7):1034-1041. doi: 10.1080/14767058.2019.1623776. Epub 2019 Jun 11.

  PMID: 31185762 BACKGROUND

• Hoppe KK, Schiff MA, Peterson SE, Gravett MG. 30 mL Single- versus 80 mL double-balloon catheter for pre-induction cervical ripening: a randomized controlled trial. J Matern Fetal Neonatal Med. 2016;29(12):1919-25. doi: 10.3109/14767058.2015.1067297.

  PMID: 26302817 BACKGROUND

• Cook Medical. (2021) A nonpharmaceutical option for preinduction dilation. Cervical ripening balloon with stylet.

  BACKGROUND

• Atad J, Hallak M, Ben-David Y, Auslender R, Abramovici H. Ripening and dilatation of the unfavourable cervix for induction of labour by a double balloon device: experience with 250 cases. Br J Obstet Gynaecol. 1997 Jan;104(1):29-32. doi: 10.1111/j.1471-0528.1997.tb10644.x.

  PMID: 8988692 BACKGROUND

• Beaty O 3rd, Sloop CH, Schmid HE Jr, Buckalew VM Jr. Renin response and angiotensinogen control during graded hemorrhage and shock in the dog. Am J Physiol. 1976 Oct;231(4):1300-7. doi: 10.1152/ajplegacy.1976.231.4.1300.

  PMID: 984215 BACKGROUND

• Embrey MP, Mollison BG. The unfavourable cervix and induction of labour using a cervical balloon. J Obstet Gynaecol Br Commonw. 1967 Feb;74(1):44-8. doi: 10.1111/j.1471-0528.1967.tb03931.x. No abstract available.

  PMID: 6018096 BACKGROUND

• "Options for second-trimester termination." Contemporary OB/GYN, Nov. 2013, www.contemporaryobgyn.net/view/options-second-trimester-termination. Accessed 16 Mar. 2025.

  BACKGROUND

• Lambert SJ, Lunde B, Porsch L, Stoffels G, MacIsaac L, Dayananda I, Dragoman MV. Adjuvant misoprostol or mifepristone for cervical preparation with osmotic dilators before dilation and evacuation. Contraception. 2024 Apr;132:110364. doi: 10.1016/j.contraception.2024.110364. Epub 2024 Jan 11.

  PMID: 38218312 BACKGROUND

• White KO, Jones HE, Shorter J, Norman WV, Guilbert E, Lichtenberg ES, Paul M. Second-trimester surgical abortion practices in the United States. Contraception. 2018 Apr 14:S0010-7824(18)30140-9. doi: 10.1016/j.contraception.2018.04.004. Online ahead of print.

  PMID: 29665357 BACKGROUND

• Casey FE, Ye PP, Perritt JD, Moreno-Ruiz NL, Reeves MF. A randomized controlled trial evaluating same-day mifepristone and misoprostol compared to misoprostol alone for cervical preparation prior to second-trimester surgical abortion. Contraception. 2016 Aug;94(2):127-33. doi: 10.1016/j.contraception.2016.02.032. Epub 2016 Mar 4.

  PMID: 26948184 BACKGROUND

• Goldberg AB, Fortin JA, Drey EA, Dean G, Lichtenberg ES, Bednarek PH, Chen BA, Dutton C, McKetta S, Maurer R, Winikoff B, Fitzmaurice GM. Cervical Preparation Before Dilation and Evacuation Using Adjunctive Misoprostol or Mifepristone Compared With Overnight Osmotic Dilators Alone: A Randomized Controlled Trial. Obstet Gynecol. 2015 Sep;126(3):599-609. doi: 10.1097/AOG.0000000000000977.

  PMID: 26196084 BACKGROUND

• Shaw KA, Shaw JG, Hugin M, Velasquez G, Hopkins FW, Blumenthal PD. Adjunct mifepristone for cervical preparation prior to dilation and evacuation: a randomized trial. Contraception. 2015 Apr;91(4):313-9. doi: 10.1016/j.contraception.2014.11.014. Epub 2014 Dec 12.

  PMID: 25499589 BACKGROUND

• Diedrich JT, Drey EA, Newmann SJ. Society of Family Planning clinical recommendations: Cervical preparation for dilation and evacuation at 20-24 weeks' gestation. Contraception. 2020 May;101(5):286-292. doi: 10.1016/j.contraception.2020.01.002. Epub 2020 Jan 31.

  PMID: 32007418 BACKGROUND

• Sanchez-Ramos L, Levine LD, Sciscione AC, Mozurkewich EL, Ramsey PS, Adair CD, Kaunitz AM, McKinney JA. Methods for the induction of labor: efficacy and safety. Am J Obstet Gynecol. 2024 Mar;230(3S):S669-S695. doi: 10.1016/j.ajog.2023.02.009. Epub 2023 Jul 13.

  PMID: 38462252 BACKGROUND

MeSH Terms

Conditions

Dilatation, Pathologic

Interventions

Catheters

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Equipment and Supplies

Study Officials

• Tessa Madden, MD

  Yale University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yale Family Planning

CONTACT

203-785-5074; fpresearch@yale.edu

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: September 22, 2025
• First Posted: September 30, 2025
• Study Start: December 3, 2025
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2028
• Last Updated: February 5, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)