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

Официальное название

Cervical Ripening Double Balloon Catheters Versus Osmotic Dilators For Cervical Preparation Before Dilation & Evacuation: A Randomized Controlled Trial

Обзор

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.

Подробное описание

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.

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.

Вмешательства

• Устройство 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.
• Устройство 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.

Первичные конечные точки

• Mean Cervical Dilation [Срок оценки: Day 1 (cervical preparation visit) to Day 2 (D&E)]

Вторичные конечные точки (2)

• Need for Mechanical Dilation at the Time of Procedural Abortion [Срок оценки: Day 2 (D&E)]
• Mean Total Procedure Time [Срок оценки: Day 2 (D&E)]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Yale Family Planning Clinic — New Haven

Публикации

• 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
• 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. PMID 18929686
• 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
• 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. PMID 30741051
• 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
• 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
• Cook Medical. (2021) A nonpharmaceutical option for preinduction dilation. Cervical ripening balloon with stylet.

Идентификаторы

NCT: NCT07200115 · 2000040146

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗