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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01063244

Enrollment

Registered

2010-02-05

Start date

2009-01-31

Completion date

2012-01-31

Last updated

2016-04-18

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

Conditions

Pregnancy

Keywords

pregnancy, induction of Labor, Cervical ripening, Foley balloon

Brief summary

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

Detailed 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

Interventions

DEVICEfoley balloon only

place foley balloon only in cervix

DEVICEfoley balloon with weight attached

foley balloon with 1000cc IV bag attached

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 45 Years

Healthy volunteers

Inclusion criteria

* Term pregnancy scheduled for induction of labor

Exclusion criteria

* Preterm pregnancy that require induction for fetal indications

Design outcomes

Primary

Measure	Time frame
Time to effectively ripen cervix	to effective cervical ripening

Countries

United States

Outcome results

None listed

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