Cervical Preparation Prior to Dilation and EvacuationCRDB RCTNCT07200115
RCT of Cervical Ripening Double Ballon Catheter Prior to Dilation and Evacuation.
A study testing Cervical Ripening Double Balloon (CRDB) Catheter and Osmotic Dilators in people with Cervical Preparation Prior to Dilation and Evacuation, run by Yale University at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cervical Preparation Prior to Dilation and Evacuation
- What is being tested?
- Cervical Ripening Double Balloon (CRDB) Catheter and Osmotic Dilators
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Dec 2025to Sep 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Spontaneous or induced fetal demise.
- Multiple pregnancy.
- Preterm prelabor rupture of membranes (PPROM).
- Intraamniotic infection.
- Active genital tract infection.
- Active vaginal bleeding.
Show all 12Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Yale Family Planning Clinic
New Haven, Connecticut, 06519
Yale Family Planning, 203-785-5074, fpresearch@yale.edu
Yale Family Planning
About this study
Official title: Cervical Ripening Double Balloon Catheters Versus Osmotic Dilators For Cervical Preparation Before Dilation & Evacuation: A Randomized Controlled Trial
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.
Read the detailed description
This study is a two-arm, non-blinded, randomized controlled trial of a cervical ripening double balloon (CRDB) catheter compared to osmotic dilators (e.g., laminaria and/or Dilapan-S) for overnight cervical preparation prior to dilation and evacuation (D\&E). The primary outcome will be mean cervical dilation as assessed by the physician immediately prior to D\&E.
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.
- 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.
- 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.
- Being tested
- Cervical Ripening Double Balloon (CRDB) Catheter, Osmotic Dilators
- Keywords
- cervical preparation, osmotic dilators, cervical ripening double balloon catheter, dilation and evacuation
- Medical subject headings
- Dilatation, Pathologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cervical Ripening Double Balloon (CRDB) CatheterDevice
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 DilatorsDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Cervical Ripening Double Balloon (CRDB) Catheter | Experimental | Not described Receives: Device: Cervical Ripening Double Balloon (CRDB) Catheter |
| Osmotic Dilators | Active comparator | Not described Receives: Device: Osmotic Dilators |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Cervical Dilation
Cervical dilation will be measured in centimeters.
Measured: Day 1 (cervical preparation visit) to Day 2 (D&E)
Secondary outcomes (2)
Need for Mechanical Dilation at the Time of Procedural Abortion
This is a binary "yes/no" outcome reported as the percentage of patients needing mechanical dilation in our experimental arm compared to the active comparator arm.
Measured: Day 2 (D&E)
Mean Total Procedure Time
Procedure time will be measured in minutes.
Measured: Day 2 (D&E)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2025
- Study start3 Dec 2025
- Primary completionSep 2027 (estimated)
- Study completionSep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for Cervical Preparation Prior to Dilation and EvacuationStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tessa Madden, MD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07200115
- Sponsor's protocol ID
- 2000040146
- Acronym
- CRDB RCT
- Status last verified
- Feb 2026
- First submitted
- 22 Sep 2025
- Last updated
- 5 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 8559528Cook 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.
PubMed 18929686Liu 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.
PubMed 39067560Ornat 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.
PubMed 30741051Solt 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.
PubMed 31185762Hoppe 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.
PubMed 26302817Cook 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.
PubMed 8988692Beaty 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.
PubMed 984215Embrey 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.
PubMed 6018096"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.
PubMed 38218312White 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.
PubMed 29665357Casey 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.
PubMed 26948184
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cervical Ripening Double Balloon Catheters Versus Osmotic Dilators For Cervical Preparation Before Dilation & Evacuation: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07200115
- Acronym / sponsor ID
- CRDB RCT / 2000040146
- Keywords
- cervical preparation, osmotic dilators, cervical ripening double balloon catheter, dilation and evacuation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Study start
- 3 Dec 2025 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2028 (estimated)
- First posted
- 30 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study is a two-arm, non-blinded, randomized controlled trial of a cervical ripening double balloon (CRDB) catheter compared to osmotic dilators (e.g., laminaria and/or Dilapan-S) for overnight cervical preparation prior to dilation and evacuation (D\&E). The primary outcome will be mean cervical dilation as assessed by the physician immediately prior to D\&E.
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.
- 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.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cervical Ripening Double Balloon (CRDB) Catheter | Experimental | Device: Cervical Ripening Double Balloon (CRDB) Catheter |
| Osmotic Dilators | Active comparator | Device: Osmotic Dilators |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (12 listed)
- Spontaneous or induced fetal demise.
- Multiple pregnancy.
- Preterm prelabor rupture of membranes (PPROM).
- Intraamniotic infection.
- Active genital tract infection.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cervical Ripening Double Balloon (CRDB) CatheterThe 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. | Device | Cervical Ripening Double Balloon (CRDB) Catheter |
| Osmotic DilatorsOsmotic 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. | Device | Osmotic Dilators |
Primary outcome
Mean Cervical Dilation
Time frame: Day 1 (cervical preparation visit) to Day 2 (D&E)
Cervical dilation will be measured in centimeters.
2 secondary outcomes
Need for Mechanical Dilation at the Time of Procedural Abortion
Time frame: Day 2 (D&E)
Mean Total Procedure Time
Time frame: Day 2 (D&E)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2026.
- Background: PubMed 8559528Atad 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.
- BackgroundCook Medical. Cook Cervical Ripening Balloon with Stylet.
- Background: PubMed 18929686Harris 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.
- Background: PubMed 39067560Liu 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.
- Background: PubMed 30741051Ornat 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.
- Background: PubMed 31185762Solt 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.
- Background: PubMed 26302817Hoppe 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.
- BackgroundCook Medical. (2021) A nonpharmaceutical option for preinduction dilation. Cervical ripening balloon with stylet.
- Background: PubMed 8988692Atad 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.
- Background: PubMed 984215Beaty 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.
- Background: PubMed 6018096Embrey 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.
- Background"Options for second-trimester termination." Contemporary OB/GYN, Nov. 2013, www.contemporaryobgyn.net/view/options-second-trimester-termination. Accessed 16 Mar. 2025.
- Individual participant dataSharing planned: No
Related trials for Cervical Preparation Prior to Dilation and Evacuation
Recruiting
Cervical Preparation for Same-Day Dilation & Evacuation
Abortion, Second Trimester, Procedural Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Tessa Madden, MD principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cervical Ripening Double Balloon (CRDB) Catheter and Osmotic Dilators in people with Cervical Preparation Prior to Dilation and Evacuation, run by Yale University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yale Family Planning (203-785-5074, fpresearch@yale.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Cervical Dilation (time frame: Day 1 (cervical preparation visit) to Day 2 (D&E)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07200115, which also lists 19 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2026.