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Outpatient transcervical foley balloon for Induced Birth

N/A

Recruiting

Led By Atinuke Akinpeloye, MD

Research Sponsored by Hurley Medical Center

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from time of rupture of membranes until delivery of the newborn

Awards & highlights

Study Summary

This trial compares two methods for prepping for labor: outpatient transcervical foley balloon & inpatient vaginal misoprostol. It'll look at time from admission to delivery & risk of c-section.

Eligible Conditions

Induced Birth
Vaginal Birth After Cesarean (VBAC)

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from hospital admission until delivery of the newborn

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from hospital admission until delivery of the newborn

This trial's timeline: 3 weeks for screening, Varies for treatment, and from hospital admission until delivery of the newborn 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 from hospital admission to delivery of the newborn

Secondary outcome measures

Admission white blood cell count

Cervical examination at the time of admission

Cesarean delivery

+15 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Outpatient transcervical foley balloonExperimental Treatment1 Intervention

These participants will receive a catheter which will be placed by a physician present in the clinic, however, patient are discharged home for 12 hours until their time of induction of labor.

Group II: Inpatient Vaginal MisoprostolActive Control1 Intervention

These participants will receive intravaginal Misoprostol in the inpatient setting per our standard hospital protocol for cervical ripening.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Hurley Medical CenterLead Sponsor

5 Previous Clinical Trials

3,234 Total Patients Enrolled

Atinuke Akinpeloye, MDPrincipal InvestigatorHurley Medical Canter

Media Library

Inpatient Vaginal Misoprostol Clinical Trial Eligibility Overview. Trial Name: NCT05798728 — N/A

Induced Birth Research Study Groups: Inpatient Vaginal Misoprostol, Outpatient transcervical foley balloon

Induced Birth Clinical Trial 2023: Inpatient Vaginal Misoprostol Highlights & Side Effects. Trial Name: NCT05798728 — N/A

Inpatient Vaginal Misoprostol 2023 Treatment Timeline for Medical Study. Trial Name: NCT05798728 — N/A

Frequently Asked Questions

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

Is this trial available for individuals 45 years of age or older?

"To qualify for this medical trial, potential candidates must be above the legal age and under 65 years of age."

Answered by AI

What is the scope of individuals taking part in this trial?

"Affirmative. Per the clinicaltrials.gov listing, this medical study is currently recruiting participants since being first listed on June 9th 2022 and updated most recently on March 22nd 2023. The trial requires 300 volunteers from a single site to be enrolled."

Answered by AI

Are there any unfilled positions available in this clinical trial?

"Correct. According to the clinicaltrials.gov, this trial is actively recruiting patients. The investigation was initially listed on June 9th 2022 and has been updated as recently as March 22nd 2023. 300 participants are required from a single site for completion of the study."

Answered by AI

How can I become involved in this clinical trial?

"This clinical trial seeks 300 participants with a history of vaginal birth after cesarean section (VBAC) between the ages 18 and 65. Prospective enrollees must also meet extra criteria, such as having their baby in cephalic presentation."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Outpatient Transcervical Balloon For Induction of Labor

Atinuke Akinpeloye 2022. "Outpatient Transcervical Balloon For Induction of Labor". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05798728.