Patient Satisfaction During Outpatient Versus Inpatient Foley Catheter Induction of Labor (NCT02975167) | Clinical Trial Compass
CompletedNot Applicable
Patient Satisfaction During Outpatient Versus Inpatient Foley Catheter Induction of Labor
United States94 participantsStarted 2016-11
Plain-language summary
Labor induction is one of the most common obstetric procedures performed in the U.S. In 2012, the last year for which data is available, 23.7% of all deliveries were the result of inductions. Labor induction first requires cervical ripening, which can be accomplished by several different methods. Vaginal or oral prostaglandins, extra amniotic saline infusion, osmotic dilators and transcervical Foley catheters are all widely used instruments for pre-induction cervical ripening. The ideal cervical ripening tool is safe for both mother and fetus, incurs low cost, does not require extensive monitoring, and causes minimal maternal discomfort. The Foley catheter has been found to be both safe and effective, but little is known about patient satisfaction with the device in an in-patient and out-patient setting. The proposed study will investigate patient satisfaction in a randomized controlled trial of in-patient versus out-patient use of Foley catheters.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* \> 18 yo
* Singleton pregnancy
* ≥ 39 weeks gestation
* Vertex presenting fetus
Exclusion Criteria:
* \< 18 years of age
* Maternal cardiac disease
* Class C diabetes mellitus or worse (as defined by the White classification system for diabetes in pregnancy)
* Gestational or chronic hypertension
* Active or history of venous thromboembolic disease requiring chemical anticoagulation
* Bleeding disorders
* History of placental abruption during current gestation
* Fetal anomalies
* Intrauterine growth restriction \< 5th percentile
* Prior uterine scar
* Vasa or placenta previa
* Active genital herpes
* Non-vertex fetal lie
* Amniotic fluid index (AFI) \< 5cm
* Multiple gestation
* (Pre)eclampsia
* Latex allergy
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Patient satisfaction scores
Timeframe: Through study completion - expected to be one year