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.
• Singleton pregnancy
Cephalic fetal presentation
Gestational age ≥ 37+0 weeks
Indication for labor induction (e.g., postdates, maternal hypertension)
• Premature rupture of membranes (PROM)
Placenta previa, vasa previa, or abnormal placentation
Active genital tract infection
Prior classical cesarean section or extensive uterine surgery
Parallel
Higroscopic Cervical ripening
DeviceParticipants 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.
Cervical ripening via CRB
DeviceDouble 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.
Time from initiation of cervical ripening to time of delivery measure in hours and minutes
Change in Bishop score after device removal
Bishop score scaled from 0 to 10 (higher values indicated better cervical ripening)
Mode of delivery
spontaneous vaginal delivery, operative vaginal delivery, emergency cesarean delivery
Need for additional ripening agent
after the removal of CRB or dilapanS needs of using misoprol or dinoprostone to complete cervical ripening
Maternal discomfort assessed by VAS
Pain was assessed using the Visual Analog Scale (VAS), ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores represent worse outcomes.
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