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

NCT ID: NCT07010653

Last Updated: 2025-06-08

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 126 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-30
• Study Completion Date: 2026-12-31

Brief Summary

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.

Conditions

Induction of Labor

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Dilapan-S

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

Group Type: EXPERIMENTAL

Higroscopic Cervical ripening

Intervention Type: DEVICE

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.

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.

Group Type: ACTIVE_COMPARATOR

Cervical ripening via CRB

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of Roma La Sapienza

OTHER

Sponsor Role: lead

Responsible Party

Giuseppe Rizzo

Prof. Giuseppe Rizzo

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Giuseppe RIZZO, Professor

Role: CONTACT

giuseppe.rizzo@uniroma1.it

+393386973001

Other Identifiers

400/8.04.2025 4a3

Identifier Type: -

Identifier Source: org_study_id