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Foley Bulb Traction for Cervical Ripening

NCT00976703 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 197

Last updated 2013-06-07

Study results available
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Summary

This study aims to determine what type of traction, weighted bag or inner thigh taping, on foley catheters for cervical ripening results in a greater cervical dilation and shorter length of labor.

The primary outcomes are post-ripening dilation of 3 cm or more and time to delivery.

The secondary outcomes are patient pain/comfort rating and method of delivery. The investigators hypothesize that the use a weighted bag will result in a 20% increase in post-ripening dilation of at least 3 cm and a shorter average length of labor.

Conditions

  • Cervical Ripening
  • Induction of Labor

Interventions

OTHER

weighted bag

For the weighted bag, a 500cc saline bag will be taped to an empty Foley bag which will be attached to the cervical Foley catheter. This bag will then be placed to gravity over the end of the bed. The bed will be raised so that the bag does not touch the floor. The foley and the bag will be re-assessed every 30min by the nursing staff.

OTHER

leg taping

For the leg taping, the cervical foley catheter will be pulled to gentle traction and attached to the patient's inner thigh using a reclosable foley catheter fastener. The foley catheter and the traction will be assessed every 30min by the nursing staff. The tension will be renewed and the Foley re-adjusted if necessary at each check.

Sponsors & Collaborators

  • MetroHealth Medical Center

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-12-31
Primary Completion
2012-07-31
Completion
2012-08-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00976703 on ClinicalTrials.gov