Dilapan-S Versus Double Balloon Catheter (CRB) for Preinduction of Labor at Term

N/ANot Yet RecruitingNCT07010653

University of Roma La Sapienza126 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

126

Conditions

Induction of Labor

Interventions

Higroscopic Cervical ripeningDEVICE

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.

Cervical ripening via CRBDEVICE

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.

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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 Outcomes

Change in Bishop score after device removal

Bishop score scaled from 0 to 10 (higher values indicated better cervical ripening)

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

spontaneous vaginal delivery, operative vaginal delivery, emergency cesarean delivery

Time frame: 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

Time frame: 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.

Time frame: from CRB insertion or DilapanS removal (12 hours)

Apgar Score

0 to 10 (10 better newborn cindition)

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

number of uterine contractions every 10 minutes measured

Time frame: 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

Time frame: From enrollment to delivery (labor measured in hours)

Postpartum hemorrhage

blood loss \> 500 ml for spontaneous delivery; \> 1000 ml for cesarean delivery

Time frame: From delivery to the first day (hours(