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Foley Bulb
Outpatient Cervical Ripening for Pregnancy
N/A
Waitlist Available
Led By Tania Esaoff, MD
Research Sponsored by Cedars-Sinai Medical Center
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 2 year
Awards & highlights
Study Summary
This trial looks at whether starting the induction process at an outpatient clinic is more effective and safer for patients.
Who is the study for?
This trial is for pregnant individuals scheduled for labor induction with conditions like gestational diabetes or chronic hypertension. They must be at full term, carrying one baby in head-down position, and able to reach the hospital quickly if needed. It's not for those with certain placenta issues, heart disease, latex allergy, previous uterine surgery, or complications like preeclampsia.Check my eligibility
What is being tested?
The study is testing patient satisfaction when they go home after having a foley bulb placed to help ripen the cervix before labor induction versus staying in the hospital. The goal is to see if this outpatient procedure is safe and works well.See study design
What are the potential side effects?
While specific side effects are not listed here, cervical ripening procedures can sometimes cause discomfort, cramping or irregular contractions. There may also be risks associated with traveling back home after placement.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Cesarean section rate
Secondary outcome measures
Apgar scores
NICU admissions
Patient satisfaction (Pain /discomfort)
Trial Design
2Treatment groups
Active Control
Group I: Outpatient Cervical RipeningActive Control1 Intervention
Patients who are randomized to this arm will be allowed discharged home for 12 hours after fetal status is assessed and noted to be reassuring with the foley bulb in place. They will return sooner if they experience rupture of membranes or enter active labor or if the foley bulb falls out.
Group II: Inpatient Cervical RipeningActive Control1 Intervention
In this arm, the fetus will be assessed and a foley bulb placed but these patients will be kept in the hospital.
Find a Location
Who is running the clinical trial?
Cedars-Sinai Medical CenterLead Sponsor
499 Previous Clinical Trials
164,057 Total Patients Enrolled
Tania Esaoff, MDPrincipal InvestigatorCedars-Sinai Medical Center, Department of Obstetrics and Gynecology, Division of Maternal Fetal Medicine
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I currently have an active genital herpes infection.I am scheduled for labor induction due to conditions like diabetes or high blood pressure.My placenta covers my cervix and/or is abnormally attached to my uterus.I have experienced vaginal bleeding without a known cause.I have had surgery on my uterus before.I have a heart condition as a mother.
Research Study Groups:
This trial has the following groups:- Group 1: Outpatient Cervical Ripening
- Group 2: Inpatient Cervical Ripening
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there still opportunities for participants in this clinical investigation?
"Per information found on clinicaltrials.gov, this research is not presently recruiting patients. This project was initially posted April 1st 2012 and underwent the most recent modification May 23rd 2012. Although enrollment has closed at this moment, there are 79 other studies actively requiring volunteers."
Answered by AI
Who has the qualifications to join this investigative endeavor?
"This trial seeks 800 expectant mothers aged 18-60 who meet the additional requirements of term pregnancy and scheduled induction for labor (due to conditions such as gestational diabetes or chronic hypertension)."
Answered by AI
Is the current research effort open to elderly applicants?
"This medical trial only enrolls participants between 18 and 60. For those that are younger than 18 or older than 65, there are separate clinical trials available; 21 for the former group and 34 for the latter cohort."
Answered by AI
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