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

NCT07010653 | Not Yet Recruiting

• 1 other identifier: 400/8.04.2025 4a3
• Study Type: interventional
• Target: 126
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• Time from initiation of cervical ripening to time of delivery measure in hours and minutes

  from the time of beginning of cervical ripening to the time of delivery measure in hours and minutes

Secondary Outcomes (10)

• Change in Bishop score after device removal

  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

  at the time of delivery

• Need for additional ripening agent

  From removal of CRB or dilapanS to 96 hours after enrollment

• Maternal discomfort assessed by VAS

  from CRB insertion or DilapanS removal (12 hours)

• Apgar Score

  at the time of delivery

Study Arms (2)

Dilapan-S

EXPERIMENTAL

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

Device: Higroscopic Cervical ripening

Double Balloon Catheter (CRB)

ACTIVE COMPARATOR

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.

Device: Cervical ripening via CRB

Interventions

Higroscopic Cervical ripening 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.

Dilapan-S

Cervical ripening via CRB 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.

Double Balloon Catheter (CRB)

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Roma La Sapienza: lead

Central Study Contacts

Giuseppe RIZZO, Professor

CONTACT

+393386973001; giuseppe.rizzo@uniroma1.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Giuseppe Rizzo

Study Record Dates

• First Submitted: May 12, 2025
• First Posted: June 8, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: June 8, 2025

Record last verified: 2025-05