Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Inpatient Versus Outpatient Cervical Ripening

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03769610
Recruitment Status : Recruiting
First Posted : December 7, 2018
Last Update Posted : December 13, 2018
Sponsor:
Information provided by (Responsible Party):
Rebecca Pierce-Williams, LifeBridge Health

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.


Condition or disease Intervention/treatment Phase
Pregnancy Related Labor Induction Cervical Ripening Other: Inpatient Foley catheter Other: Outpatient Foley catheter Not Applicable

Detailed Description:

From 1990 to 2010, the rates of induction of labor increased from 9.6% to 23.8%(1). Recent data from 2014 reports a rate of 23.2%(2). Labor induction may be medically indicated, in cases in which the risk of continuing pregnancy is greater than delivery, or in some cases electively after 39 weeks of gestation.

Prior to starting an induction of labor, a digital exam is performed to determine the status of the cervix in terms of its dilatation, effacement, position, softness, and fetal station. If the cervical status is considered favorable for labor, then generally oxytocin is started to induce uterine contractions. If the cervix is not considered favorable, a method of cervical ripening is employed to induce physical changes in the cervix that make it more favorable for labor.

This process involves inflammatory infiltration and release of metalloproteases that degrade collagen and result in cervical remodeling(3). The primary benefit of cervical ripening is reducing the length of labor; however, some studies have suggested that it may lower the rate of cesarean section(4,5). The Bishop score (see table 1) is used as a scoring tool to determine the status of the cervix(6). Most studies define a score of 6 or less as an unfavorable cervix, while a score of greater than 8 is favorable, and has a similar probability of vaginal delivery to spontaneous labor(7).

Commonly used methods for cervical ripening include pharmacologic forms such as synthetic prostaglandin E1 (PGE1, i.e. misoprostol) and prostaglandin E2 (PGE2, i.e. dinoprostone), or mechanical ripening with balloon (i.e. Foley) catheters.

Quality improvement, increasing efficiency, and decreasing cost continue to be challenges for individual hospitals and the entire health care system. Induction of labor, especially with an unfavorable cervix, is associated with longer lengths of stay for patients, which results in increased cost(8).

Foley catheters are a safe, inexpensive and effective option for cervical ripening. A study by Sciscione et al in 2001 compared Foley bulb use in inpatient versus outpatient settings and found the outpatient use to be as effective for cervical ripening. The primary objective of this study was to compare efficacy of these two approaches and the outcomes were similar. There were no cases of endomyometritis or chorioamnionitis(9). While they did report a shorter amount of time in the hospital with outpatient management, this was not a primary outcome of the study and they did not compare costs. Recently there has been an increased focus on the costs of medical care and patient satisfaction. Consequently, these are increasingly important outcomes that research needs to focus on. It is our hope that the findings of our study will support the use of outpatient pre-induction of labor cervical ripening and result in a more efficient use of resources and improved patient satisfaction.

The purpose of this study is to compare the use of a Foley catheter for cervical ripening in the inpatient and outpatient setting, in order to evaluate the difference in the amount of time spent on labor and delivery during induction of labor, as well as the difference in costs. An important secondary outcome we plan to evaluate as well is patient satisfaction. This will be a randomized controlled trial, with the study population being pregnant women at ≥ 37 weeks of gestation undergoing induction of labor. The projected time-frame will be from October 2016 to June 2018. The expected outcome is that outpatient cervical ripening with Foley catheter use will result in shorter lengths of stay on labor and delivery and less cost than inpatient Foley catheter use in patients undergoing induction of labor. Additionally, we anticipate greater patient satisfaction with outpatient management.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Subjects will be randomly assigned to either inpatient or outpatient cervical ripening with a Foley catheter.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Inpatient Versus Outpatient Transcervical Foley Catheter Use for Cervical Ripening: A Randomized Controlled Trial
Actual Study Start Date : January 4, 2017
Estimated Primary Completion Date : July 30, 2019
Estimated Study Completion Date : December 10, 2019

Arm Intervention/treatment
Active Comparator: Inpatient Foley catheter
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
Experimental: Outpatient Foley catheter
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



Primary Outcome Measures :
  1. Difference in time on labor and delivery [ Time Frame: (approximately) 2 days ]
    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.

  2. Difference in cost [ Time Frame: (approximately 5 days) ]
    To compare the difference in cost for hospitalization in patients undergoing inpatient versus outpatient cervical ripening with a transcervical Foley catheter.


Secondary Outcome Measures :
  1. Patient satisfaction [ Time Frame: (approximately 5 days) ]
    Each subject is asked to complete a survey

  2. Provider satisfaction [ Time Frame: (approximately 3 years) ]
    After enrollment is completed, providers will be surveyed on their satisfaction

  3. Length of labor induction [ Time Frame: (approximately 3 days) ]
    Total length of induction, including cervical ripening

  4. Type of delivery [ Time Frame: (approximately 3 days) ]
    Vaginal delivery versus cesarean section

  5. Maternal blood loss [ Time Frame: (approximately 3 days) ]
    Total blood loss at delivery

  6. Infection rates [ Time Frame: (approximately 5 days) ]
    Maternal intrapartum and postpartum infections

  7. Apgar scores [ Time Frame: (approximately 10 minutes) ]
    Neonatal Apgar scores at 1 and 5 minutes, and 10 minutes if reported

  8. Non-reassuring fetal heart tracings [ Time Frame: (approximately 3 days) ]
    Any non-reassuring fetal monitoring during labor


Other Outcome Measures:
  1. NICU admission [ Time Frame: (approximately 5 days) ]
    Any neonatal ICU admissions

  2. Neonatal fever [ Time Frame: (approximately 5 days) ]
    Any neonatal fever

  3. Total time on pitocin [ Time Frame: (approximately 3 days) ]
    Time on pitocin for induction

  4. Maximum dose of pitocin [ Time Frame: (approximately 3 days) ]
    Max dose



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   14 Years to 45 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Pregnant women
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03769610


Contacts
Layout table for location contacts
Contact: Rebecca Pierce-Williams, DO 5185732837 bmokhiber@gmail.com
Contact: Robert Ehsanipoor, MD 410-601-8373 rehsanip@lifebridgehealth.org

Locations
Layout table for location information
United States, Maryland
Sinai Hospital of Baltimore Recruiting
Baltimore, Maryland, United States, 21224
Contact: Rebecca Pierce-Williams, DO    518-573-2837    bmokhiber@gmail.com   
Sponsors and Collaborators
LifeBridge Health

Publications:
Layout table for additonal information
Responsible Party: Rebecca Pierce-Williams, Resident physician, LifeBridge Health
ClinicalTrials.gov Identifier: NCT03769610     History of Changes
Other Study ID Numbers: 2383
First Posted: December 7, 2018    Key Record Dates
Last Update Posted: December 13, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Rebecca Pierce-Williams, LifeBridge Health:
Foley
Transcervical