Induction of LaborNCT07010653
Dilapan-S Versus Double Balloon Catheter (CRB) for Preinduction of Labor at Term
A study testing Higroscopic Cervical ripening and Cervical ripening via CRB in people with Induction of Labor, run by University of Roma La Sapienza.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Induction of Labor
- What is being tested?
- Higroscopic Cervical ripening and Cervical ripening via CRB
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2025to Dec 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- • 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
Who cannot join
- • 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
About this study
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.
- Conditions
- Induction of Labor
- Being tested
- Higroscopic Cervical ripening, Cervical ripening via CRB
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: Higroscopic Cervical ripening |
| 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. Receives: Device: Cervical ripening via CRB |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time from initiation of cervical ripening to time of delivery measure in hours and minutes
Measured: from the time of beginning of cervical ripening to the time of delivery measure in hours and minutes
Secondary outcomes (10)
Change in Bishop score after device removal
Bishop score scaled from 0 to 10 (higher values indicated better cervical ripening)
Measured: 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
Measured: 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
Measured: 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.
Measured: from CRB insertion or DilapanS removal (12 hours)
Apgar Score
0 to 10 (10 better newborn cindition)
Measured: at the time of delivery
NICU admission
Measured: From delivery to 28 days of life of the newborn
Chorioamnionitis
Measured: From enrollment to 6 weeks postpartum
Uterine Tachysystole
number of uterine contractions every 10 minutes measured
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
Measured: From enrollment to delivery (labor measured in hours)
Postpartum hemorrhage
blood loss > 500 ml for spontaneous delivery; > 1000 ml for cesarean delivery
Measured: From delivery to the first day (hours(
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2025
- Study start1 Dec 2025
- Primary completionSep 2026 (estimated)
- Study completionDec 2026 (estimated)
Why it stopped: The ethics committee required insurance coverage for randomisation, which could not be obtained from any insurer. The study was therefore not started as an RCT and was converted to an observational study with device selected by the clinician.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Induction of LaborStudies of the same condition, open and under way.
- More trials run by University of Roma La SapienzaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Roma La Sapienza
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giuseppe Rizzo, University of Roma La Sapienza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07010653
- Sponsor's protocol ID
- 400/8.04.2025 4a3
- Status last verified
- Oct 2026
- First submitted
- 12 May 2025
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dilapan-S Versus Double Balloon Catheter (CRB) for Preinduction of Labor at Term
- ClinicalTrials.gov ID
- NCT07010653
- Acronym / sponsor ID
- 400/8.04.2025 4a3
- Conditions
- Induction of Labor
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The ethics committee required insurance coverage for randomisation, which could not be obtained from any insurer. The study was therefore not started as an RCT and was converted to an observational study with device selected by the clinician.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Roma La SapienzaUniversity, hospital or other
- Study start
- 1 Dec 2025 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 8 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dilapan-S | Experimental | Device: Higroscopic Cervical ripeningDilapan-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 |
| Double Balloon Catheter (CRB) | Active comparator | Device: Cervical ripening via CRBParticipants 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- • Singleton pregnancy
Key exclusion criteria (7 listed)
- • Premature rupture of membranes (PROM)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Higroscopic Cervical ripeningParticipants 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. | Device | Dilapan-S |
| Cervical ripening via CRBDouble 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. | Device | Double Balloon Catheter (CRB) |
Primary outcome
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
10 secondary outcomes
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
Mode of delivery
Time frame: at the time of delivery
Need for additional ripening agent
Time frame: From removal of CRB or dilapanS to 96 hours after enrollment
Maternal discomfort assessed by VAS
Time frame: from CRB insertion or DilapanS removal (12 hours)
Apgar Score
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
Time frame: From enrollment to delivery (duration of labor measured in hours)
Changes in fetal heart rate trace
Time frame: From enrollment to delivery (labor measured in hours)
Postpartum hemorrhage
Time frame: From delivery to the first day (hours(
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Higroscopic Cervical ripening and Cervical ripening via CRB in people with Induction of Labor, run by University of Roma La Sapienza.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.