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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dilapan-S | Experimental | Dilapan-S 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 |
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| Double Balloon Catheter (CRB) | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Higroscopic Cervical ripening | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Time from initiation of cervical ripening to time of delivery measure in hours and minutes | from the time of beginning of cervical ripening to the time of delivery measure in hours and minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Bishop score after device removal | Bishop score scaled from 0 to 10 (higher values indicated better cervical ripening) | 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 |
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Inclusion Criteria:
• Singleton pregnancy
Exclusion Criteria:
• Premature rupture of membranes (PROM)
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Giuseppe RIZZO, Professor | Contact | +393386973001 | giuseppe.rizzo@uniroma1.it |
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| Cervical ripening via CRB | Device | 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. |
|
spontaneous vaginal delivery, operative vaginal delivery, emergency cesarean delivery |
| at the time of delivery |
| Need for additional ripening agent | after the removal of CRB or dilapanS needs of using misoprol or dinoprostone to complete cervical ripening | From removal of CRB or dilapanS to 96 hours after enrollment |
| 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. | from CRB insertion or DilapanS removal (12 hours) |
| Apgar Score | 0 to 10 (10 better newborn cindition) | at the time of delivery |
| NICU admission | From delivery to 28 days of life of the newborn |
| Chorioamnionitis | From enrollment to 6 weeks postpartum |
| Uterine Tachysystole | number of uterine contractions every 10 minutes measured | From enrollment to delivery (duration of labor measured in hours) |
| Changes in fetal heart rate trace | changes in fetal heart baseline, variability, presence of deceleration | From enrollment to delivery (labor measured in hours) |
| Postpartum hemorrhage | blood loss > 500 ml for spontaneous delivery; > 1000 ml for cesarean delivery | From delivery to the first day (hours( |