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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.
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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cervical Ripening Double Balloon (CRDB) Catheter | Experimental |
| |
| Osmotic Dilators | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Cervical Dilation | Cervical dilation will be measured in centimeters. | Day 1 (cervical preparation visit) to Day 2 (D&E) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Day 2 (D&E) |
| Mean Total Procedure Time |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yale Family Planning | Contact | 203-785-5074 | fpresearch@yale.edu |
| Name | Affiliation | Role |
|---|---|---|
| Tessa Madden, MD | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale Family Planning Clinic | Recruiting | New Haven | Connecticut | 06519 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 8559528 | Background | 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. | |
| Background | Cook Medical. Cook Cervical Ripening Balloon with Stylet. | ||
| 18929686 |
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| ID | Term |
|---|---|
| D004108 | Dilatation, Pathologic |
| ID | Term |
|---|---|
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D057785 | Catheters |
| ID | Term |
|---|---|
| D004864 | Equipment and Supplies |
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| 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. |
|
Procedure time will be measured in minutes. |
| Day 2 (D&E) |
| 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. |
| 39067560 | 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. |
| 30741051 | 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. |
| 31185762 | 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. |
| 26302817 | 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. |
| Background | Cook Medical. (2021) A nonpharmaceutical option for preinduction dilation. Cervical ripening balloon with stylet. |
| 8988692 | 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. |
| 984215 | 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. |
| 6018096 | 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. |
| Background | "Options for second-trimester termination." Contemporary OB/GYN, Nov. 2013, www.contemporaryobgyn.net/view/options-second-trimester-termination. Accessed 16 Mar. 2025. |
| 38218312 | 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. |
| 29665357 | 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. |
| 26948184 | 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. |
| 26196084 | 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. |
| 25499589 | 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. |
| 32007418 | 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. |
| 38462252 | 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. |