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NCT07010653
Dilapan-S Versus Double Balloon Catheter (CRB) for Preinduction of Labor at Term
Conditions: Induction of Labor
Sex: Female
Ages: 18 Years – 45 Years
Healthy volunteers: Yes
Phase: NA
Sponsor: University of Roma La Sapienza
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.
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
Source: ClinicalTrials.gov (NCT07010653). StuddyBuddy aggregates publicly available trial information.