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

S

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)

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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