Patient Satisfaction Clinical Trial
Official title:
Patient Satisfaction During Outpatient Versus Inpatient Foley Catheter Induction of Labor
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.
Labor induction is one of the most common obstetric procedures performed in the U.S. In 2013, the last year for which data is available, 23.1% of all deliveries were the result of inductions. Labor induction often first requires cervical ripening, which can be accomplished by several different methods. Pharmacologic cervical ripening approaches include vaginal or oral prostaglandin administration. Mechanical cervical ripening methods include osmotic dilators such as laminaria, and transcervical Foley catheters with or without extra amniotic saline infusion. The ideal cervical ripening tool is effective, safe for both mother and fetus, incurs low cost, does not require extensive monitoring, and causes minimal maternal discomfort. Several recent meta-analyses have demonstrated both the safety and efficacy of the Foley catheter for pre-induction cervical ripening. When compared to prostaglandins, studies have shown that use of the transcervical Foley catheter for pre-induction cervical ripening results in either shortened or no statistically significant difference in vaginal delivery rates at 24 hours. No studies have demonstrated longer duration to vaginal delivery and cesarean delivery rates are equivalent. In addition, women with Foley catheters experience less uterine hyper-stimulation resulting in fetal heart rate changes as compared to those who receive prostaglandins. Other than one study suggesting increased risks of chorioamnionitis and neonatal infection, the vast majority of research suggests Foley catheters are overwhelming safe with little risk of severe maternal or neonatal morbidity. Due to its safety profile and the ongoing desire to reduce healthcare costs, many institutions have initiated outpatient cervical ripening protocols. Studies suggest that outpatient cervical ripening with transcervical Foley catheter is both safe and effective. In addition, some studies demonstrate women who underwent outpatient cervical ripening spent less time in the hospital during their labor induction, sometimes resulting in significant cost savings at those institutions. The combination of safety, ease of use and cost savings potential make outpatient cervical ripening with a Foley catheter an appealing tool for both clinicians and patients. However, data on patient satisfaction with almost all methods of cervical ripening is sparse. Existing data on patient satisfaction of outpatient versus inpatient induction of labor stems from prior studies which used vaginal misoprostol gel or isosorbide mononitrate as induction agents. While one study suggests overall satisfaction with outpatient Foley catheter cervical ripening, a randomized controlled trial on this topic has yet to be performed. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Not yet recruiting |
NCT04079543 -
NPO and Patient Satisfaction in the Cath Lab
|
N/A | |
Enrolling by invitation |
NCT05053958 -
Using Superimposition of Intra-Oral Scan and CBCT in Single Implant Restorations in Aesthetic Zone.
|
N/A | |
Completed |
NCT04204785 -
Noise in the OR at Induction: Patient and Anesthesiologists Perceptions
|
N/A | |
Completed |
NCT04774562 -
The Effect of Video-Assisted Discharge Education After Total Hip Replacement Surgery
|
N/A | |
Terminated |
NCT04604340 -
Radial Versus Femoral Arterial Access for Cerebral Angiography in Adolescents
|
N/A | |
Recruiting |
NCT04539210 -
Screw-retained Maxillary Complete Denture With Electric Welded Metal Framework Versus Cast One, Patient Satisfaction Assessment.
|
N/A | |
Completed |
NCT02924974 -
Spinal Morphine in Robotic Assisted Radical Prostatectomy
|
Phase 4 | |
Completed |
NCT01052415 -
POL and Access Intervention to Reduce HIV Stigma Among Service Providers in China
|
N/A | |
Recruiting |
NCT06044103 -
Patient-controlled Sedation During Repair of Obstetric Perineal Lacerations
|
Phase 4 | |
Not yet recruiting |
NCT05670080 -
Does MI Have a Therapeutic Role in Arthroscopic Rotator Cuff Repair?
|
N/A | |
Completed |
NCT06114524 -
Effect of Binaural Beats on Level of Anxiety and Toleration in Patients Undergoing Upper Gastrointestinal Endoscopy Without Sedation
|
N/A | |
Completed |
NCT06141122 -
The Colonoscopy Booklet:Effect of a Recipe Resource on Quality of Colonoscopy Bowel Preparation and Patient Experience
|
N/A | |
Not yet recruiting |
NCT04534868 -
Patient Acceptance And Satisfaction of Teledermoscopy In General Practice In a Belgian Rural Area
|
N/A | |
Completed |
NCT04823390 -
Anesthetist Controlled Versus Patient-controlled Sedation: Risks and Benefits
|
Phase 1 | |
Recruiting |
NCT05884684 -
What is the Potential Impact of Reviewing Post-procedure Images With Patients Following Interventional Spine Procedures.
|
N/A | |
Recruiting |
NCT05613439 -
The Fast-track Centre for Hip and Knee Replacement Database
|
||
Recruiting |
NCT06451510 -
Knee Osteoarthritis in the Region of Norrbotten
|
||
Completed |
NCT04420000 -
Effects of Mindfulness Therapy in Patients With Acromegaly and Cushing
|
N/A | |
Withdrawn |
NCT04625842 -
Focus Group Interview Study on Patient Experiences and Satisfaction
|
N/A | |
Recruiting |
NCT04842240 -
Comparison of Patient Reported Outcome Measures Using the BREAST-Q Questionnaire in Patients Undergoing Pre Versus Sub-pectoral Implant Based Immediate Breast Reconstruction.
|