Pregnancy Related Clinical Trial
Official title:
Inpatient Versus Outpatient Transcervical Foley Catheter Use for Cervical Ripening: A Randomized Controlled Trial
NCT number | NCT03769610 |
Other study ID # | 2383 |
Secondary ID | |
Status | Terminated |
Phase | N/A |
First received | |
Last updated | |
Start date | January 4, 2017 |
Est. completion date | April 1, 2021 |
Verified date | April 2021 |
Source | LifeBridge Health |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Induction of labor is a process of stimulating uterine contractions before the onset of labor, with a goal of achieving vaginal birth. The cervix (the lower part of the uterus that connects to the vagina) must dilate (open) in order to allow passage of the baby into the vagina and through the birth canal. A process called "cervical ripening" is often performed prior to labor induction to prepare the cervix for labor and therefore shorten the length of the labor. There are various pharmacologic and mechanical methods of cervical ripening that result in the physical softening and distensibility of the cervix. Mechanical dilation with a small balloon (i.e. a Foley catheter) placed in the cervix is one of the most commonly used, safe, inexpensive, and effective methods to achieve cervical ripening. In most hospitals, cervical ripening is performed in the hospitals; however, some hospitals allow women to undergo cervical ripening at home with a transcervical Foley catheter. The goal of this study is to compare the use of a Foley catheter for cervical ripening in the inpatient (in-hospital) and outpatient (at home) settings. We anticipate that outpatient use will lead to a shorter amount of time that a woman spends in the hospital, decreased cost, and good patient satisfaction.
Status | Terminated |
Enrollment | 30 |
Est. completion date | April 1, 2021 |
Est. primary completion date | April 1, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 14 Years to 45 Years |
Eligibility | Inclusion Criteria: - Pregnancies at least 37 weeks' gestation, undergoing induction of labor, with an unfavorable cervix, defined as a Bishop score = 6 - The fetus must be in the cephalic presentation - Indications for induction of labor include, but are not limited to, the following: - Elective induction of labor at 39 weeks' gestation - Intrauterine growth restriction - Chronic hypertension - Diabetes - Gestational diabetes - Prior stillbirth - Other medical indications for induction of labor, as deemed appropriate by the obstetric provider, such as Systemic Lupus Erythematosus, Cholestasis of Pregnancy etc. Exclusion Criteria: - Gestational hypertension - Preeclampsia - Non-reassuring fetal testing - Multi-fetal gestation - Oligohydramnios - Fetal anomaly - Less than 37 weeks - Bishop score > 6 - Ruptured membranes - Contraindication to vaginal delivery including: active Herpes lesion, HIV VL >1000 copies/mL, placenta previa, vasa previa, breech presentation, prior classical cesarean section or transfundal myomectomy - Poor access to telephone or transportation - Latex allergy - Any other condition for which the managing physician or investigator deem outpatient management inappropriate. - Currently participating in another clinical trial |
Country | Name | City | State |
---|---|---|---|
United States | Sinai Hospital of Baltimore | Baltimore | Maryland |
United States | Thomas Jefferson University | Philadelphia | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
LifeBridge Health | Thomas Jefferson University |
United States,
ACOG Practice Bulletin No. 107: Induction of labor. Obstet Gynecol. 2009 Aug;114(2 Pt 1):386-397. doi: 10.1097/AOG.0b013e3181b48ef5. Review. — View Citation
BISHOP EH. PELVIC SCORING FOR ELECTIVE INDUCTION. Obstet Gynecol. 1964 Aug;24:266-8. — View Citation
Hamilton BE, Martin JA, Osterman MJ, Curtin SC, Matthews TJ. Births: Final Data for 2014. Natl Vital Stat Rep. 2015 Dec;64(12):1-64. — 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. Review. — 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
Sciscione AC, Muench M, Pollock M, Jenkins TM, Tildon-Burton J, Colmorgen GH. Transcervical Foley catheter for preinduction cervical ripening in an outpatient versus inpatient setting. Obstet Gynecol. 2001 Nov;98(5 Pt 1):751-6. — View Citation
Smith R. Parturition. N Engl J Med. 2007 Jan 18;356(3):271-83. Review. — View Citation
Thomas J, Fairclough A, Kavanagh J, Kelly AJ. Vaginal prostaglandin (PGE2 and PGF2a) for induction of labour at term. Cochrane Database Syst Rev. 2014 Jun 19;(6):CD003101. doi: 10.1002/14651858.CD003101.pub3. Review. — View Citation
von Gruenigen VE, Powell DM, Sorboro S, McCarroll ML, Kim U. The financial performance of labor and delivery units. Am J Obstet Gynecol. 2013 Jul;209(1):17-9. doi: 10.1016/j.ajog.2013.02.019. Epub 2013 Feb 11. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | NICU admission | Any neonatal ICU admissions | (approximately 5 days) | |
Other | Neonatal fever | Any neonatal fever | (approximately 5 days) | |
Other | Total time on pitocin | Time on pitocin for induction | (approximately 3 days) | |
Other | Maximum dose of pitocin | Max dose | (approximately 3 days) | |
Primary | Difference in time on labor and delivery | To evaluate the difference in the amount of time a patient spends on labor and delivery during induction of labor when undergoing inpatient versus outpatient transcervical Foley catheter for induction of labor. | (approximately) 2 days | |
Primary | Difference in cost | To compare the difference in cost for hospitalization in patients undergoing inpatient versus outpatient cervical ripening with a transcervical Foley catheter. | (approximately 5 days) | |
Secondary | Patient satisfaction | Each subject is asked to complete a survey | (approximately 5 days) | |
Secondary | Provider satisfaction | After enrollment is completed, providers will be surveyed on their satisfaction | (approximately 3 years) | |
Secondary | Length of labor induction | Total length of induction, including cervical ripening | (approximately 3 days) | |
Secondary | Type of delivery | Vaginal delivery versus cesarean section | (approximately 3 days) | |
Secondary | Maternal blood loss | Total blood loss at delivery | (approximately 3 days) | |
Secondary | Infection rates | Maternal intrapartum and postpartum infections | (approximately 5 days) | |
Secondary | Apgar scores | Neonatal Apgar scores at 1 and 5 minutes, and 10 minutes if reported | (approximately 10 minutes) | |
Secondary | Non-reassuring fetal heart tracings | Any non-reassuring fetal monitoring during labor | (approximately 3 days) |
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