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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 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

Side effects data

From 2023 Phase 4 trial • 108 Patients • NCT04028765
6%
Blood transfusion
100%
80%
60%
40%
20%
0%
Study treatment Arm
Oral Misoprostol-Mothers
Oxytocin-Fetus/Neonate
Oral Misoprostol-Fetus/Neonate
Oxytocin-Mothers

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.

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
~103 spots leftby Jun 2025
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