← Back to Search

Procedure

6 hour foley catheter retention for Labor Induction

N/A

Waitlist Available

Research Sponsored by Icahn School of Medicine at Mount Sinai

Eligibility Criteria Checklist

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

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 1, 5 minutes of infant delivery

Awards & highlights

Study Summary

This trial will help determine how long a foley catheter (single balloon) should be kept in place for induction of labor, in order to achieve vaginal delivery while minimizing the length of labor.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 1, 5 minutes of infant delivery

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 1, 5 minutes of infant delivery

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1, 5 minutes of infant 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

Length of Labor

Secondary outcome measures

Number of Cesarean delivery

Number of Maternal Intrapartum Fever

Number of NICU admission

+4 more

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: 6 hour foley catheter retentionActive Control1 Intervention

Patients will have the foley catheter in place for up to 6 hours starting from insertion time to removal. If the catheter falls out earlier than the 6 hour mark, the patient will still be included for analysis.

Group II: 12 hour foley balloon retentionPlacebo Group1 Intervention

Patients will have the foley catheter in place for up to 12 hours starting from insertion time to removal. If the catheter falls out earlier than the 12 hour mark, the patient will still be included for analysis.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Icahn School of Medicine at Mount SinaiLead Sponsor

858 Previous Clinical Trials

524,286 Total Patients Enrolled

Lois Brustman, MDStudy DirectorIcahn School of Medicine at Mount Sinai

1 Previous Clinical Trials

109 Total Patients Enrolled

Frequently Asked Questions

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

Are senior citizens being included in the sample group for this research project?

"The age range for partaking in this trial is restricted to 18 years old and below 50."

Answered by AI

Are there still opportunities to join this clinical trial?

"Affirmative, the clinicaltrials.gov website states that this experiment is still accepting participants. This trial was publicized on November 7th 2021 and it was recently updated on February 24th 2022. A total of 356 individuals are required to be enrolled from one medical facility for this research project to continue."

Answered by AI

Is participation in this medical research open to me?

"This study is calling for 356 individuals of uterine contraction between the ages 18 to 50. To be eligible, applicants must meet a set of prerequisites: Age range from 18-50 years old, Bishop score ≤ 6; Singleton pregnancies ≥ 37 weeks gestation and absence of labor or rupture of membranes."

Answered by AI

How many participants are being taken on for this medical exploration?

"Affirmative, the clinicaltrials.gov website confirms that this research is presently enrolling participants. Originally published on November 7th 2021 and last updated February 24th 2022, 356 people are needed for this single-site study."

Answered by AI

Recent research and studies

Obstetrics & GynecologyJournal

Double-balloon Device for 6 Compared with 12 Hours for Cervical Ripening

Bleicher, Inna, Elena Dikopoltsev, Einav Kadour-Ferro, Rami Sammour, Ron Gonen, Shlomi Sagi, Aya Eshel, Liraz Nussam, and Dana Vitner. 2020. “Double-balloon Device for 6 Compared with 12 Hours for Cervical Ripening”. Obstetrics & Gynecology. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/aog.0000000000003804.

American Journal of Obstetrics and GynecologyJournal

Six Versus Twelve Hours of Single-balloon Catheter Placement with Oxytocin Administration for Labor Induction: A Randomized Controlled Trial

Lassey, Sarah C., Hilary R. Haber, Alexa Kanbergs, Julian N. Robinson, and Sarah E. Little. 2021. “Six Versus Twelve Hours of Single-balloon Catheter Placement with Oxytocin Administration for Labor Induction: A Randomized Controlled Trial”. American Journal of Obstetrics and Gynecology. Elsevier BV. doi:10.1016/j.ajog.2021.03.021.

clinicaltrials.govStudy

Foley Catheter Induction

Melissa Lozano 2021. "Foley Catheter Induction". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05257187.