Comparison of Foley Balloon With or Without Traction for the Cervical Ripening

St. Luke's Hospital, Pennsylvania

Status and phase: Completed; Phase 3

Conditions: Pregnancy

Treatments: Device: foley balloon only; Device: foley balloon with weight attached

Study type: Interventional

Funder types: Other

Identifiers

NCT01063244

SLHN-08-21

Details and patient eligibility

About

We will compare the use of foley bulb catheters placed in the cervix for ripening of the cervix for labor induction,.

Full description

One arm will have the foley balloon placed alone in the cervix. And one arm will have the foley balloon placed in the cervix and then attached to a weight (1000 cc Iv Bag of fluid). Our hypothesis is that the weighted balloon will be more effective than the non-weighted balloon in the ripening of the cervix for induction of labor

Enrollment: 65 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Term pregnancy scheduled for induction of labor

Exclusion criteria

• Preterm pregnancy that require induction for fetal indications

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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65 participants in 2 patient groups

FoleyBalloon

Active Comparator group

Description:

foley balloon placed in the cervix

Treatment:

Device: foley balloon only

foley balloon with weight

Active Comparator group

Description:

foley balloon with weight attached

Treatment:

Device: foley balloon with weight attached