Dilapan-S Versus Double Balloon Catheter (CRB) for Preinduction of Labor at Term
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Higroscopic Cervical ripening, Cervical ripening via CRB.
- Who it may be relevant to
- Registry conditions: Induction of Labor. Basic parameters: 18 years — 45 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Device 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. - 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.
Primary outcome measures
- Time from initiation of cervical ripening to time of delivery measure in hours and minutes [Time frame: from the time of beginning of cervical ripening to the time of delivery measure in hours and minutes]
Secondary outcome measures (10)
- Change in Bishop score after device removal [Time frame: 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 [Time frame: at the time of delivery]
- Need for additional ripening agent [Time frame: From removal of CRB or dilapanS to 96 hours after enrollment]
- Maternal discomfort assessed by VAS [Time frame: from CRB insertion or DilapanS removal (12 hours)]
- Apgar Score [Time frame: at the time of delivery]
- NICU admission [Time frame: From delivery to 28 days of life of the newborn]
- Chorioamnionitis [Time frame: From enrollment to 6 weeks postpartum]
- Uterine Tachysystole [Time frame: From enrollment to delivery (duration of labor measured in hours)]
- Changes in fetal heart rate trace [Time frame: From enrollment to delivery (labor measured in hours)]
- Postpartum hemorrhage [Time frame: From delivery to the first day (hours(]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07010653 · 400/8.04.2025 4a3