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

University of Roma La Sapienza

Status: Begins enrollment in 2 months

Conditions: Induction of Labor

Treatments: Device: Higroscopic Cervical ripening; Device: Cervical ripening via CRB

Study type: Interventional

Funder types: Other

Identifiers

NCT07010653

400/8.04.2025 4a3

Details and patient eligibility

About

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.

Enrollment: 126 estimated patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• • 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

Exclusion criteria

• • 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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126 participants in 2 patient groups

Dilapan-S

Experimental group

Description:

Dilapan-S 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

Treatment:

Device: Higroscopic Cervical ripening

Double Balloon Catheter (CRB)

Active Comparator group

Description:

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.

Treatment:

Device: Cervical ripening via CRB