NCT01170819

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
210

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jun 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2010

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 23, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 27, 2010

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

December 13, 2011

Status Verified

December 1, 2011

Enrollment Period

1.3 years

First QC Date

July 23, 2010

Last Update Submit

December 9, 2011

Conditions

Cervical RipeningLabor Induction

Keywords

Cervical ripeningInduction of laborProstaglandinsMechanical methodsBalloon catheter

Outcome Measures

Primary Outcomes (1)

  • Vaginal delivery within 24 hours

    24 hours from start of cervical ripening

Secondary Outcomes (3)

  • Cesarean section rate

    48 hours from start of ripening

  • Onset of active labor

    36 hours from start of ripening

  • Uterine hyperstimulation

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

Study Arms (2)

Dinoprostone Vaginal Insert

ACTIVE COMPARATOR
Drug: Dinoprostone 10 mg controlled-release vaginal insert

Double Balloon Catheter

EXPERIMENTAL
Device: Double balloon catheter

Interventions

Double balloon catheterDEVICE

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
Double Balloon Catheter
Dinoprostone 10 mg controlled-release vaginal insertDRUG

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

Also known as: PROPESS®, Ferring Pharmaceuticals
Dinoprostone Vaginal Insert

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Del Ponte Hospital

Varese, 21100, Italy

Location

Related Publications (1)

  • de Vaan MD, Ten Eikelder ML, Jozwiak M, Palmer KR, Davies-Tuck M, Bloemenkamp KW, Mol BWJ, Boulvain M. Mechanical methods for induction of labour. Cochrane Database Syst Rev. 2023 Mar 30;3(3):CD001233. doi: 10.1002/14651858.CD001233.pub4.

    PMID: 36996264DERIVED

MeSH Terms

Interventions

Dinoprostone

Intervention Hierarchy (Ancestors)

Prostaglandins EProstaglandinsEicosanoidsFatty Acids, UnsaturatedFatty AcidsLipidsAutacoidsInflammation MediatorsBiological Factors

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

July 23, 2010

First Posted

July 27, 2010

Study Start

June 1, 2010

Primary Completion

September 1, 2011

Study Completion

December 1, 2011

Last Updated

December 13, 2011

Record last verified: 2011-12

Locations

IT(1)