Inpatient Versus Outpatient Cervical Ripening

NCT03769610 | Terminated

• 1 other identifier: 2383
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Pregnancy Related; Labor; Induction; Cervical Ripening

Keywords

Foley; Transcervical

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (8)

• Patient satisfaction

  (approximately 5 days)

• Provider satisfaction

  (approximately 3 years)

• Length of labor induction

  (approximately 3 days)

• Type of delivery

  (approximately 3 days)

• Maternal blood loss

  (approximately 3 days)

Other Outcomes (4)

• NICU admission

  (approximately 5 days)

• Neonatal fever

  (approximately 5 days)

• Total time on pitocin

  (approximately 3 days)

Study Arms (2)

Inpatient Foley catheter

ACTIVE COMPARATOR

Subjects will be admitted to a room on labor and delivery and will be monitored with the external fetal monitor (EFM) and tocometer (a device to monitor contractions). If she is contracting less than every 2 minutes, intravenous (IV) Pitocin will be started at 2 milliunits/minute and increased per hospital protocol. While on pitocin, she will remain on continuous EFM and tocometer. She will also be kept on a clear liquid diet with intravenous fluids per standard protocol. If the Foley catheter has not been expulsed in 24 hours, it will be removed. After expulsion or removal of the Foley catheter, induction may proceed as deemed clinically appropriate by the managing physician. No further cervical ripening will be performed after the Foley catheter is expulsed/removed, or after 24 hours.

Other: Inpatient Foley catheter

Outpatient Foley catheter

EXPERIMENTAL

Subjects are asked to return to the hospital \~12 hours after placement. Subjects are to return to the hospital if they develop heavy vaginal bleeding, decreased fetal movement, rupture of membranes, or increasingly painful or frequent contractions requiring an epidural or pain relief. Once admitted, subjects will be evaluated for expulsion of the catheter. If the catheter is in place IV Pitocin will be started. If the catheter has been expulsed, the induction will proceed as deemed clinically appropriate. After 24 hours, if the Foley catheter is still in the cervix it will be removed and the induction will proceed as deemed clinically appropriate.

Other: Outpatient Foley catheter

Interventions

Inpatient Foley catheter OTHER

Inpatient Foley catheter

Outpatient Foley catheter OTHER

Outpatient Foley catheter

Eligibility Criteria

• Age: 14 Years - 45 Years
• Gender Eligibility Details: Pregnant women
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• LifeBridge Health: lead
• Thomas Jefferson University: collaborator

Study Sites (2)

Sinai Hospital of Baltimore

Baltimore, Maryland, 21224, United States

Location

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

Related Publications (10)

• 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.

  PMID: 25603115 BACKGROUND

• 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.

  PMID: 26727629 BACKGROUND

• Smith R. Parturition. N Engl J Med. 2007 Jan 18;356(3):271-83. doi: 10.1056/NEJMra061360. No abstract available.

  PMID: 17229954 BACKGROUND

• 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;2014(6):CD003101. doi: 10.1002/14651858.CD003101.pub3.

  PMID: 24941907 BACKGROUND

• 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.

  PMID: 22419277 BACKGROUND

• BISHOP EH. PELVIC SCORING FOR ELECTIVE INDUCTION. Obstet Gynecol. 1964 Aug;24:266-8. No abstract available.

  PMID: 14199536 BACKGROUND

• ACOG Practice Bulletin No. 107: Induction of labor. Obstet Gynecol. 2009 Aug;114(2 Pt 1):386-397. doi: 10.1097/AOG.0b013e3181b48ef5. No abstract available.

  PMID: 19623003 BACKGROUND

• 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.

  PMID: 23410692 BACKGROUND

• 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. doi: 10.1016/s0029-7844(01)01579-4.

  PMID: 11704164 BACKGROUND

• Alfirevic Z, Gyte GM, Nogueira Pileggi V, Plachcinski R, Osoti AO, Finucane EM. Home versus inpatient induction of labour for improving birth outcomes. Cochrane Database Syst Rev. 2020 Aug 27;8(8):CD007372. doi: 10.1002/14651858.CD007372.pub4.

  PMID: 32852803 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident physician

Model Details: Subjects will be randomly assigned to either inpatient or outpatient cervical ripening with a Foley catheter.

Study Record Dates

• First Submitted: October 12, 2017
• First Posted: December 7, 2018
• Study Start: January 4, 2017
• Primary Completion: April 1, 2021
• Study Completion: April 1, 2021
• Last Updated: April 14, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)