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Tension for Induction of Labor

N/A

Recruiting

Research Sponsored by Hawaii Pacific Health

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age greater than or equal to 18 years

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up will measure length of time from beginning of induction with the foley balloon until delivery

Awards & highlights

Study Summary

This trial compared the use of a transcervical catheter with tension versus no tension for pre-induction cervical ripening.

Who is the study for?

This trial is for first-time pregnant women over 18 with a single baby in head-down position, who need help starting labor at Kapiolani Medical Center. They should have an unopened cervix and a Bishop score of 6 or less, which means the body isn't quite ready for childbirth on its own.Check my eligibility

What is being tested?

The study is testing two ways to use a Foley bulb catheter to ripen the cervix and get it ready for labor: one group will have tension applied to the catheter, while the other won't. The goal is to see which method works best for starting labor.See study design

What are the potential side effects?

Possible side effects from using a Foley bulb may include discomfort or pain where the catheter enters, bleeding, infection risk increase, or causing strong contractions that might lead to other interventions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ will measure length of time from beginning of induction with the foley balloon until delivery

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~will measure length of time from beginning of induction with the foley balloon until delivery

This trial's timeline: 3 weeks for screening, Varies for treatment, and will measure length of time from beginning of induction with the foley balloon until delivery for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Time to Delivery

Trial Design

2Treatment groups

Active Control

Group I: TensionActive Control1 Intervention

foley balloon will be placed on tension and taped to thigh at 10 cm. Misoprostil will be placed in posterior vaginal vault.

Group II: No tensionActive Control1 Intervention

The foley balloon will be loosely taped without tension to the patient's thigh. Misoprostil will be placed in the posterior vaginal vault.

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Hawaii Pacific HealthLead Sponsor

9 Previous Clinical Trials

451 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the scope of participation in this trial?

"Indeed, the information found on clinicaltrials.gov confirms that this trial is actively seeking participants. This medical study was originally posted in April 16th of 2018 and has since been updated as recently as August 4th 2022. It requires 150 individuals to be recruited from 1 centre."

Answered by AI

Is there still availability for participants in this trial?

"Affirmative. Clinicaltrials.gov has data to suggest that this medical study is actively recruiting participants, with a total of 150 patients needed from 1 centre. The trial was first published on April 16th 2018 and the most recent update occured in August 4th 2022."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Tension Versus no Tension With Foley Bulb Induction

Holly Olson 2018. "Tension Versus no Tension With Foley Bulb Induction". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03588585.

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