Dilapan-S Versus Double Balloon Catheter (CRB) for Preinduction of Labor at Term

Обзор

Induction of labor (IOL) is a frequently performed procedure in obstetrics, aimed to achieve vaginal delivery when continuing the pregnancy is no longer advisable. A key determinant of IOL success is cervical ripening, particularly when the cervix is initially unfavorable. A range of preinduction methods is available, encompassing both mechanical and pharmacological approaches. Among mechanical techniques, the double balloon catheter (CRB) facilitates cervical dilation by applying direct pressure, which stimulates local prostaglandin release. In contrast, Dilapan-S, a synthetic osmotic dilator, works by gradually expanding through the absorption of cervical fluids, thereby applying gentle mechanical pressure. While both methods are widely used and generally considered safe, there is limited evidence directly comparing their effectiveness and patient-centered outcomes. Mechanical methods are associated with a lower risk of uterine hyperstimulation compared to pharmacological alternatives. The choice between CRB and Dilapan-S may significantly influence labor duration, cesarean delivery rates, maternal comfort, and hospital resource utilization. This study aims to fill the existing knowledge gap by directly comparing Dilapan-S and CRB for term preinduction, with a focus on clinical efficacy and maternal satisfaction.

Вмешательства

• Устройство Higroscopic Cervical ripening
  Participants assigned to the Dilapan-S group will have 3 to 5 rods inserted under aseptic conditions. Placement will follow manufacturer instructions, and rods will remain in place for up to 12 hours unless spontaneous labor or device expulsion occurs earlier. Upon removal, cervical status will be assessed, and induction will continue with prostaglandins or oxytocin based on standard care.
• Устройство Cervical ripening via CRB
  Double Balloon Catheter (CRB) Participants randomized to CRB will undergo insertion of a double balloon catheter with inflation of each balloon (approximately 80 mL saline each) according to established protocols. The catheter will remain for up to 12 hours or until spontaneous labor or expulsion. Post-removal management will mirror that of the Dilapan-S group.

Первичные конечные точки

• Time from initiation of cervical ripening to time of delivery measure in hours and minutes [Срок оценки: from the time of beginning of cervical ripening to the time of delivery measure in hours and minutes]

Вторичные конечные точки (10)

• Change in Bishop score after device removal [Срок оценки: From the time of beggining of cervical ripening to the time of removal of the device (CRB or dilapan S) 12 hours]
• Mode of delivery [Срок оценки: at the time of delivery]
• Need for additional ripening agent [Срок оценки: From removal of CRB or dilapanS to 96 hours after enrollment]
• Maternal discomfort assessed by VAS [Срок оценки: from CRB insertion or DilapanS removal (12 hours)]
• Apgar Score [Срок оценки: at the time of delivery]
• NICU admission [Срок оценки: From delivery to 28 days of life of the newborn]
• Chorioamnionitis [Срок оценки: From enrollment to 6 weeks postpartum]
• Uterine Tachysystole [Срок оценки: From enrollment to delivery (duration of labor measured in hours)]
• Changes in fetal heart rate trace [Срок оценки: From enrollment to delivery (labor measured in hours)]
• Postpartum hemorrhage [Срок оценки: From delivery to the first day (hours(]

Критерии участия

Критерии включения

• • Singleton pregnancy

• Cephalic fetal presentation
• Gestational age ≥ 37+0 weeks
• Indication for labor induction (e.g., postdates, maternal hypertension)
• Bishop score ≤ 6
• Maternal age ≥18 years
• Ability to provide informed consent

Критерии исключения

• • Premature rupture of membranes (PROM)

• Placenta previa, vasa previa, or abnormal placentation
• Active genital tract infection
• Prior classical cesarean section or extensive uterine surgery
• Known fetal anomaly contraindicating vaginal delivery
• Allergy or sensitivity to device materials
• Any contraindication to labor induction or vaginal birth

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07010653 · 400/8.04.2025 4a3

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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