Patient Satisfaction Clinical Trial
Official title:
Patient Satisfaction During Outpatient Versus Inpatient Foley Catheter Induction of Labor
Verified date | January 2023 |
Source | MemorialCare Health System |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 160 |
Est. completion date | December 2023 |
Est. primary completion date | December 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Miller Women's and Children's Hospital Long Beach | Long Beach | California |
Lead Sponsor | Collaborator |
---|---|
MemorialCare Health System |
United States,
Gelber S, Sciscione A. Mechanical methods of cervical ripening and labor induction. Clin Obstet Gynecol. 2006 Sep;49(3):642-57. doi: 10.1097/00003081-200609000-00022. — View Citation
Heinemann J, Gillen G, Sanchez-Ramos L, Kaunitz AM. Do mechanical methods of cervical ripening increase infectious morbidity? A systematic review. Am J Obstet Gynecol. 2008 Aug;199(2):177-87; discussion 187-8. doi: 10.1016/j.ajog.2008.05.005. — View Citation
Jozwiak M, Bloemenkamp KW, Kelly AJ, Mol BW, Irion O, Boulvain M. Mechanical methods for induction of labour. Cochrane Database Syst Rev. 2012 Mar 14;(3):CD001233. doi: 10.1002/14651858.CD001233.pub2. — View Citation
Jozwiak M, ten Eikelder M, Oude Rengerink K, de Groot C, Feitsma H, Spaanderman M, van Pampus M, de Leeuw JW, Mol BW, Bloemenkamp K; PROBAAT Study Group. Foley catheter versus vaginal misoprostol: randomized controlled trial (PROBAAT-M study) and systematic review and meta-analysis of literature. Am J Perinatol. 2014 Feb;31(2):145-56. doi: 10.1055/s-0033-1341573. Epub 2013 Apr 5. — View Citation
Kandil M, Emarh M, Sayyed T, Masood A. Foley catheter versus intra-vaginal misoprostol for induction of labor in post-term gestations. Arch Gynecol Obstet. 2012 Aug;286(2):303-7. doi: 10.1007/s00404-012-2292-8. Epub 2012 Mar 21. — View Citation
Kelly AJ, Alfirevic Z, Ghosh A. Outpatient versus inpatient induction of labour for improving birth outcomes. Cochrane Database Syst Rev. 2013 Nov 12;(11):CD007372. doi: 10.1002/14651858.CD007372.pub3. — View Citation
Martin JA, Hamilton BE, Osterman MJ, Curtin SC, Matthews TJ. Births: final data for 2013. Natl Vital Stat Rep. 2015 Jan 15;64(1):1-65. — View Citation
Maslovitz S, Lessing JB, Many A. Complications of trans-cervical Foley catheter for labor induction among 1,083 women. Arch Gynecol Obstet. 2010 Mar;281(3):473-7. doi: 10.1007/s00404-009-1136-7. Epub 2009 Jun 2. — View Citation
McKenna DS, Duke JM. Effectiveness and infectious morbidity of outpatient cervical ripening with a Foley catheter. J Reprod Med. 2004 Jan;49(1):28-32. — View Citation
McMaster K, Sanchez-Ramos L, Kaunitz AM. Evaluation of a Transcervical Foley Catheter as a Source of Infection: A Systematic Review and Meta-analysis. Obstet Gynecol. 2015 Sep;126(3):539-551. doi: 10.1097/AOG.0000000000001002. — View Citation
Sciscione AC, Bedder CL, Hoffman MK, Ruhstaller K, Shlossman PA. The timing of adverse events with Foley catheter preinduction cervical ripening; implications for outpatient use. Am J Perinatol. 2014 Oct;31(9):781-6. doi: 10.1055/s-0033-1359718. Epub 2013 Dec 17. — View Citation
Sciscione AC, McCullough H, Manley JS, Shlossman PA, Pollock M, Colmorgen GH. A prospective, randomized comparison of Foley catheter insertion versus intracervical prostaglandin E2 gel for preinduction cervical ripening. Am J Obstet Gynecol. 1999 Jan;180(1 Pt 1):55-60. doi: 10.1016/s0002-9378(99)70149-3. — View Citation
* Note: There are 12 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Patient satisfaction scores | The primary outcome will be the total score on Part A of the survey, giving an overall rating of the patients' experience with treatment. Means and standard deviations of the total score will be calculated and reported by treatment group among nulliparous and multiparous patients separately. To address the main hypothesis, an ANOVA (analysis-of-variance) will be performed on an intention-to-treat basis and the stratum (nulliparous vs multiparous) will be controlled for in the analysis. The mean difference between treatment groups will be calculated and reported with a 95% confidence interval for the population difference. A two-sample t-test will be used to test for a significant difference in overall rating between in-patient versus out-patient treatment groups. | Through study completion - expected to be one year | |
Secondary | Multiparous versus Nulliparous subjects | Mean differences between in-patient and out-patient treatment will be calculated and reported with 95% confidence intervals among nulliparous and multiparous patients separately. An ANOVA test of interaction will be made in order to address whether multiparous patients rate their experience with the Foley catheter differently than do nulliparous patients. | Through study completion - expected to be one year |
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