Clinical trial NCT07010653: Dilapan-S Versus Double Balloon Catheter (CRB) for Preinduction of Labor at Term
Official title: Dilapan-S Versus Double Balloon Catheter (CRB) for Preinduction of Labor at Term
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Induction of Labor
Lead sponsor: University of Roma La Sapienza
Sponsor class: OTHER
First posted: 2025-06-08
Enrollment: 126
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Time from initiation of cervical ripening to time of delivery measure in hours and minutes
timeFrame: from the time of beginning of cervical ripening to the time of delivery measure in hours and minutes
Secondary outcomes:
measure: Change in Bishop score after device removal
timeFrame: From the time of beggining of cervical ripening to the time of removal of the device (CRB or dilapan S) 12 hours
measure: Mode of delivery
timeFrame: at the time of delivery
measure: Need for additional ripening agent
timeFrame: From removal of CRB or dilapanS to 96 hours after enrollment
measure: Maternal discomfort assessed by VAS
timeFrame: from CRB insertion or DilapanS removal (12 hours)
measure: Apgar Score
timeFrame: at the time of delivery
measure: NICU admission
timeFrame: From delivery to 28 days of life of the newborn
measure: Chorioamnionitis
timeFrame: From enrollment to 6 weeks postpartum
measure: Uterine Tachysystole
timeFrame: From enrollment to delivery (duration of labor measured in hours)
measure: Changes in fetal heart rate trace
timeFrame: From enrollment to delivery (labor measured in hours)
measure: Postpartum hemorrhage
timeFrame: From delivery to the first day (hours(
Other outcomes:
Locations:
Study officials:
References: