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The purpose of this study is to compare the efficacy of a transcervical Foley catheter with and without extra-amniotic saline infusion (EASI) for priming the cervix for labor.
In the United States, labor inductions have increased from 11% of all pregnancies in 1989 to 21% in 2004. Although the indications for labor induction vary, labor inductions as an obstetrical practice are associated with an increased risk of Cesarean delivery. As such, the rise in labor inductions has been paralleled by a rise in the cesarean rate to an all time high of 30%. The risk of cesarean can be mitigated with the use of cervical ripening agents in the setting of an unfavorable cervix. Both pharmacological ripening agents and mechanical methods are currently available for cervical priming. Methods available for mechanical dilation include, but are not limited to transcervical foley catheter alone and transcervical foley catheter with an extra-amniotic saline infusion or EASI. The potential advantage of EASI to transcervical foley catheter alone is the promotion of endogenous prostaglandin release by membrane stripping and supplying additional mechanical force. It may be disadvantageous by increasing the risk of chorioamnionitis or by diluting the prostaglandins that are released by membrane stripping. There have been two randomized trials comparing foley alone to foley with EASI. Because the results of these two trials are conflicting, we chose to conduct a randomized clinical trial of foley catheter compared to foley catheter with an EASI for labor induction and cervical ripening in women with an unfavorable cervix.
Allocation: Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Transcervical Foley Catheter, Transcervical Foley Catheter with an EASI
University of Alabama at Birmingham
University of Alabama at Birmingham
Published on BioPortfolio: 2014-07-23T21:30:03-0400
This study evaluates the addition of transcervical Foley catheter balloon and vaginal prostaglandin E2 in induction of labor at term. Half of participants will be used combine transcervica...
The investigators are performing a randomized controlled trial investigating starting cervical ripening in the outpatient setting with a mechanical method, the transcervical Foley catheter...
The overall purpose of this study is to determine if adding oxytocin to a Foley catheter for induction of labor will increase the rate of delivery within 24 hours stratified by parity.
Once admitted, women who will have a transcervical balloon catheter inserted for induction will be approached for participation in this study. If they agree to be take part in this study (...
The purpose of the present study is to evaluate the possible benefit of concurrent IV Oxytocin infusion with trans cervical Foley catheter for pre-induction cervical ripening.
Induction of labour is one of the most frequently applied obstetrical interventions globally. Many studies have compared the use of balloon catheters with pharmacological agents. Although the safety o...
Investigate the impact on prostate orientation caused by use and removal of a Foley catheter, and the dosimetric impact on men prospectively treated with prostate stereotactic body radiotherapy (SBRT)...
Evaluate the association between cervical examination after ripening with Foley catheter and labor induction outcomes.
Indwelling catheter placement is a modifiable risk factor for urethral trauma. We implemented a multidisciplinary Foley Project protocol in June 2015, which consisted of a system-wide catheter educati...
In mouse models used to study parturition or pre-clinical therapeutic testing, measurement of uterine contractions is limited to either ex vivo isometric tension or operative IUP. The goal of this stu...
Nonoperative repair of occluded vessels, ducts, or valves by insertion of a balloon catheter. It is used, among other things, to treat varices, torn retinas, renal and biliary calculi, gastric, bronchial and rectal stenoses, and heart valves, and includes catheterization with Fogarty and Foley catheters.
Nonoperative repair of occluded vessels, ducts, or valves by insertion of a balloon catheter. It is used, among other things, to treat varices, torn retinas, renal and biliary calculi, gastric, bronchial and rectal stenoses, and heart valves, and includes catheterization with Fogarty and Foley CATHETERS.
A hindrance to the passage of fluids through a CATHETER.
Infections resulting from the use of catheters. Proper aseptic technique, site of catheter placement, material composition, and virulence of the organism are all factors that can influence possible infection.
Regional infusion of drugs via an arterial catheter. Often a pump is used to impel the drug through the catheter. Used in therapy of cancer, upper gastrointestinal hemorrhage, infection, and peripheral vascular disease.
In a clinical trial or interventional study, participants receive specific interventions according to the research plan or protocol created by the investigators. These interventions may be medical products, such as drugs or devices; procedures; or change...
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