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OpenTrials
Completed

NCT Number: NCT01170819

Double Balloon Catheter Versus Dinoprostone Vaginal Insert for Cervical Ripening.

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.

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Key information

Conditions

Cervical Ripening Labor Induction

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Del Ponte Hospital

Varese, 21100, Italy

Who can participate

Healthy volunteers accepted: No

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

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

  • 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

Treatment and study plan

Double balloon catheter

Device

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.

Other names: COOK CERVICAL BALLOON, COOK UROLOGICAL INC. US

Dinoprostone 10 mg controlled-release vaginal insert

Drug

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

Other names: PROPESS®, Ferring Pharmaceuticals

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

    Time frame: 36 hours from start of ripening

    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

  3. Uterine hyperstimulation

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

Sponsors and collaborators

Lead sponsor

Università degli Studi dell'Insubria

Other

Registry information

Official study title

Double Balloon Catheter Versus Vaginal PGE2 for Pre-induction Cervical Ripening: a Randomized Study.

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Jul 27, 2010
Registry last updated
Dec 13, 2011

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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