Induction of Labor
Conditions
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.
Interventions
DEVICEHigroscopic 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.
DEVICECervical 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.
Sponsors
University of Roma La Sapienza
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mode of delivery | at the time of delivery | spontaneous vaginal delivery, operative vaginal delivery, emergency cesarean delivery |
| Need for additional ripening agent | From removal of CRB or dilapanS to 96 hours after enrollment | after the removal of CRB or dilapanS needs of using misoprol or dinoprostone to complete cervical ripening |
| Maternal discomfort assessed by VAS | from CRB insertion or DilapanS removal (12 hours) | 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. |
| Apgar Score | at the time of delivery | 0 to 10 (10 better newborn cindition) |
| Change in Bishop score after device removal | From the time of beggining of cervical ripening to the time of removal of the device (CRB or dilapan S) 12 hours | Bishop score scaled from 0 to 10 (higher values indicated better cervical ripening) |
| Chorioamnionitis | From enrollment to 6 weeks postpartum | — |
| Uterine Tachysystole | From enrollment to delivery (duration of labor measured in hours) | number of uterine contractions every 10 minutes measured |
| Changes in fetal heart rate trace | From enrollment to delivery (labor measured in hours) | changes in fetal heart baseline, variability, presence of deceleration |
| Postpartum hemorrhage | From delivery to the first day (hours( | blood loss \> 500 ml for spontaneous delivery; \> 1000 ml for cesarean delivery |
| NICU admission | From delivery to 28 days of life of the newborn | — |
Contacts
Primary ContactGiuseppe RIZZO, Professor
Outcome results
None listed