Double Balloon Catheter Versus Dinoprostone Vaginal Insert for Cervical Ripening.

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01170819

Enrollment

210

Registered

2010-07-27

Start date

2010-06-30

Completion date

2011-12-31

Last updated

2011-12-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cervical Ripening, Labor Induction

Keywords

Cervical ripening, Induction of labor, Prostaglandins, Mechanical methods, Balloon catheter

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.

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.

DRUGDinoprostone 10 mg controlled-release vaginal insert

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Vaginal delivery within 24 hours	24 hours from start of cervical ripening

Secondary

Measure	Time frame	Description
Cesarean section rate	48 hours from start of ripening	—
Onset of active labor	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
Uterine hyperstimulation	12 hours (double ballon catheter arm) and 24 hours (dinoprostone vaginal insert arm) from start of ripening	—

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026