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.
Treatment Effectiveness
Effectiveness Progress
Study Objectives
1 Primary · 7 Secondary · Reporting Duration: Day 1, 5 minutes of infant delivery
Trial Safety
Safety Progress
Trial Design
2 Treatment Groups
6 hour foley catheter retention
1 of 2
12 hour foley balloon retention
1 of 2
Active Control
Non-Treatment Group
356 Total Participants · 2 Treatment Groups
Primary Treatment: 6 hour foley catheter retention · Has Placebo Group · N/A
Trial Logistics
Trial Timeline
Who is running the clinical trial?
Eligibility Criteria
Age 18 - 50 · All Participants · 4 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:- 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.
- 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.
- Melissa Lozano 2021. "Foley Catheter Induction". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05257187.
Frequently Asked Questions
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." - Anonymous Online Contributor
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." - Anonymous Online Contributor
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." - Anonymous Online Contributor
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." - Anonymous Online Contributor