RCT of Cervical Ripening Double Ballon Catheter Prior to Dilation and Evacuation.
NCT ID: NCT07200115
Last Updated: 2025-10-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
NOT_YET_RECRUITING
NA
50 participants
INTERVENTIONAL
2025-11-30
2028-09-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Cervical Preparation for Same-Day Dilation & Evacuation
NCT06799052
Comparing 30mL Single Versus 80mL Double Balloon Catheters for Pre-induction Cervical Ripening
NCT02344459
Cervical Ripening With a Double-lumen Balloon Catheter for Six Versus Twelve Hours
NCT03086967
Comparison of Two Mechanical Methods of Outpatient Ripening of the Cervix
NCT03752073
Foley Catheter Versus Cervidil for Induction of Labor at Term
NCT01402050
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Established patients will be approached by a member of the research team about study participation after they have provided informed consent for D\&E. Allocation to the study group will be based on a 1:1 blocked randomization scheme. The participant will be informed of their assignment immediately prior to their cervical preparation procedure. Neither the physician nor the patient will be blinded to the assignment as this is not feasible given the differences in interventions.
1. Intervention Group: The physician will place a CRDB catheter as directed by the manufacturer's user guide. The uterine balloon of the CRDB catheter will be inflated with 20-40 mL of saline based upon the participant's tolerance.
2. Control Group: The physician will place osmotic dilators in the standard fashion. The number of dilators and use of laminaria, Dilapan-S, or a combination will be determined by physician preference.
On the day of the D\&E procedure, the physician will remove the cervical dilating device and measure the patient's cervical dilation. Additional data will be collected on the following items.
* Need for and amount of mechanical dilation
* Total procedure time will be calculated in minutes based on the procedure start and stop times recorded in the patient's electronic medical record.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Cervical Ripening Double Balloon (CRDB) Catheter
Cervical Ripening Double Balloon (CRDB) Catheter
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.
Osmotic Dilators
Osmotic Dilators
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Cervical Ripening Double Balloon (CRDB) Catheter
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.
Osmotic Dilators
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
18 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Yale University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Tessa Madden, MD
Role: PRINCIPAL_INVESTIGATOR
Yale University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Yale Family Planning Clinic
New Haven, Connecticut, United States
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Cook Medical. Cook Cervical Ripening Balloon with Stylet.
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.
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.
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.
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.
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.
Cook Medical. (2021) A nonpharmaceutical option for preinduction dilation. Cervical ripening balloon with stylet.
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.
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.
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.
"Options for second-trimester termination." Contemporary OB/GYN, Nov. 2013, www.contemporaryobgyn.net/view/options-second-trimester-termination. Accessed 16 Mar. 2025.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2000040146
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.