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CompletedNCT01170819Updated Dec 13, 2011

Double Balloon Catheter Versus Dinoprostone Vaginal Insert for Cervical Ripening.

A Phase 4 interventional study of Double balloon catheter and Dinoprostone 10 mg controlled-release vaginal insert in Cervical Ripening and Labor Induction, sponsored by Università degli Studi dell'Insubria. Completed at 1 site in Italy. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2011-12-13.

Sponsored by Università degli Studi dell'Insubria · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
210
Allocation
Randomized
Ages
18 Years and older
Sex
Female
01

Study summary

To compare the efficacy of transcervical double balloon catheters versus controlled release dinoprostone vaginal inserts for pre-induction cervical ripening in term women with unfavourable cervices.

02

Conditions studied

  • Cervical Ripening
  • Labor Induction

Keywords

  • Cervical ripening
  • Induction of labor
  • Prostaglandins
  • Mechanical methods
  • Balloon catheter
03

In context

Lead sponsor

Università degli Studi dell'Insubria is the lead sponsor of 67 studies on the registry; 8 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  • singleton gestation
  • gestational age greater than 34 weeks
  • cephalic presentation
  • intact membranes
  • Bishop score of ≤4
  • reactive fetal heart rate (FHR) pattern on admission

Exclusion criteria

Exclusion Criteria:

  • any condition precluding vaginal delivery
  • any contraindication to receiving prostaglandins, including history of asthma, glaucoma, or cardiac or cardiovascular disease
  • previous cesarean section or other uterine incision
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
210 participants (actual)

Study arms

  • Active comparator
    Dinoprostone Vaginal Insert

    Drug: Dinoprostone 10 mg controlled-release vaginal insert

  • Experimental
    Double Balloon Catheter

    Device: Double balloon catheter

Interventions

  • DeviceDouble balloon catheter

    The balloons either side of the cervix are inflated with 50 ml of water. The catheter is removed after 12 hours if spontaneous expulsion has not occurred.

    Also known as: COOK CERVICAL BALLOON, COOK UROLOGICAL INC. US

  • DrugDinoprostone 10 mg controlled-release vaginal insert

    Vaginal insert is placed in the posterior vaginal fornix for a maximum period of 24 hours.

    Also known as: PROPESS®, Ferring Pharmaceuticals

06

What researchers measure

Primary outcomes

  1. Vaginal delivery within 24 hours

    Time frame: 24 hours from start of cervical ripening

Secondary outcomes

  1. Cesarean section rate

    Time frame: 48 hours from start of ripening

  2. Onset of active labor

    Active labor is defined as at least 4 uterine contractions in a 30 minutes interval with a totally effaced cervix and a cervical dilatation ≥3 cm

    Time frame: 36 hours from start of ripening

  3. Uterine hyperstimulation

    Time frame: 12 hours (double ballon catheter arm) and 24 hours (dinoprostone vaginal insert arm) from start of ripening

07

Study locations

1 site
  • Del Ponte Hospital
    Varese, 21100, Italy
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 13, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01170819
Lead sponsor
Università degli Studi dell'Insubria
Responsible party
Antonella Cromi (PhD, Università degli Studi dell'Insubria) — Principal investigator
First posted
Jul 27, 2010
Start date
Jun 2010
Primary completion
Sep 2011
Completion
Dec 2011
Last update
Dec 13, 2011

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Dec 2011. You cannot join it, but the record below documents what was studied.

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