Balloon Catheter for Cervical Ripening

Completed · Not applicable

Conditions studied: Cervical Dilation

In brief

Once admitted, women who will have a transcervical balloon catheter inserted for induction will be approached for participation in this study. If they agree to be take part in this study (tape or no tape) they will be randomized into the study. After the balloon catheter is inserted, the balloon will then be filled with approximately 50-60 mL of normal saline, this is normal procedure. Study related: If randomized to "No Taping" the foley will be positioned comfortable and not placed to tension. For the "Tension" arm, tension will be placed on the balloon catheter, which will then be taped to the patient's inner thigh. The tension will be assessed and retaped as needed approximately every 30 minutes by the research and/or the nursing staff.

Key facts

Study ID

NCT02606643

Run by

St. Louis University

People needed

134

Starts

2014-10-01

Expected to finish

2016-11-01

Last updated by the study team

2018-11-07

Who can join

Age: 14 and older, up to 55. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• singleton gestation
• Bishop score less than or equal to 6
• cephalic presentation

You may not qualify if…

• prostaglandins given this admission
• any medical conditions precluding vaginal delivery
• significant cervical or intrauterine infection
• significant vaginal bleeding
• intrauterine fetal demise
• low lying placenta
• prior cervical surgery
• latex allergy

Where it is running

• St. Mary's Health Center — St Louis, Missouri, United States

Full record on ClinicalTrials.gov

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