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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-45
SponsorUniversity of Roma La Sapienza

About this trial

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.

Eligibility criteria

Qualifiers

• Singleton pregnancy

Cephalic fetal presentation

Gestational age ≥ 37+0 weeks

Indication for labor induction (e.g., postdates, maternal hypertension)

Disqualifiers

• Premature rupture of membranes (PROM)

Placenta previa, vasa previa, or abnormal placentation

Active genital tract infection

Prior classical cesarean section or extensive uterine surgery

Trial design

Treatments tested in this trial

  • Higroscopic Cervical ripening
  • Cervical ripening via CRB

Treatment groups

126 Participants
are divided into 2 treatment groups

Locations

This trial has no locations

Sponsors and collaborators