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NCT Number: NCT07010653

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

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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Key information

Conditions

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. 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

  1. 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

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

  2. Mode of delivery

    Time frame: at the time of delivery

    spontaneous vaginal delivery, operative vaginal delivery, emergency cesarean delivery

  3. Need for additional ripening agent

    Time frame: 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

  4. Maternal discomfort assessed by VAS

    Time frame: 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.

  5. Apgar Score

    Time frame: at the time of delivery

    0 to 10 (10 better newborn cindition)

  6. NICU admission

    Time frame: From delivery to 28 days of life of the newborn

  7. Chorioamnionitis

    Time frame: From enrollment to 6 weeks postpartum

  8. Uterine Tachysystole

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

    number of uterine contractions every 10 minutes measured

  9. Changes in fetal heart rate trace

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

    changes in fetal heart baseline, variability, presence of deceleration

  10. Postpartum hemorrhage

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

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

Study contacts

Contact information is provided by the study sponsor or research team.

Giuseppe RIZZO, Professor

CONTACT

[email protected]

+393386973001

Sponsors and collaborators

Lead sponsor

University of Roma La Sapienza

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jun 8, 2025
Registry last updated
Jun 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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