Double Balloon Catheter Versus Dinoprostone Vaginal Insert for Cervical Ripening.

Cervical Ripening Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01170819
• Other study ID #: 1229
• Status: Completed
• Phase: Phase 4
• First received: July 23, 2010
• Last updated: December 9, 2011
• Start date: June 2010
• Est. completion date: December 2011

Study information

• Verified date: December 2011
• Source: Università degli Studi dell'Insubria
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 210
• Est. completion date: December 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cervical Ripening
• Labor Induction

Intervention

Device:
• Double 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.

Drug:
• Dinoprostone 10 mg controlled-release vaginal insert
Vaginal insert is placed in the posterior vaginal fornix for a maximum period of 24 hours.

Locations

Country	Name	City	State
Italy	Del Ponte Hospital	Varese

Sponsors (1)

Lead Sponsor	Collaborator
Università degli Studi dell'Insubria

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Vaginal delivery within 24 hours		24 hours from start of cervical ripening	No
Secondary	Cesarean section rate		48 hours from start of ripening	Yes
Secondary	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	36 hours from start of ripening	No
Secondary	Uterine hyperstimulation		12 hours (double ballon catheter arm) and 24 hours (dinoprostone vaginal insert arm) from start of ripening	Yes