<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03769610</url>
  </required_header>
  <id_info>
    <org_study_id>2383</org_study_id>
    <nct_id>NCT03769610</nct_id>
  </id_info>
  <brief_title>Inpatient Versus Outpatient Cervical Ripening</brief_title>
  <official_title>Inpatient Versus Outpatient Transcervical Foley Catheter Use for Cervical Ripening: A Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>LifeBridge Health</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Thomas Jefferson University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>LifeBridge Health</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Induction of labor is a process of stimulating uterine contractions before the onset of&#xD;
      labor, with a goal of achieving vaginal birth. The cervix (the lower part of the uterus that&#xD;
      connects to the vagina) must dilate (open) in order to allow passage of the baby into the&#xD;
      vagina and through the birth canal. A process called &quot;cervical ripening&quot; is often performed&#xD;
      prior to labor induction to prepare the cervix for labor and therefore shorten the length of&#xD;
      the labor. There are various pharmacologic and mechanical methods of cervical ripening that&#xD;
      result in the physical softening and distensibility of the cervix. Mechanical dilation with a&#xD;
      small balloon (i.e. a Foley catheter) placed in the cervix is one of the most commonly used,&#xD;
      safe, inexpensive, and effective methods to achieve cervical ripening.&#xD;
&#xD;
      In most hospitals, cervical ripening is performed in the hospitals; however, some hospitals&#xD;
      allow women to undergo cervical ripening at home with a transcervical Foley catheter. The&#xD;
      goal of this study is to compare the use of a Foley catheter for cervical ripening in the&#xD;
      inpatient (in-hospital) and outpatient (at home) settings. We anticipate that outpatient use&#xD;
      will lead to a shorter amount of time that a woman spends in the hospital, decreased cost,&#xD;
      and good patient satisfaction.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      From 1990 to 2010, the rates of induction of labor increased from 9.6% to 23.8%(1). Recent&#xD;
      data from 2014 reports a rate of 23.2%(2). Labor induction may be medically indicated, in&#xD;
      cases in which the risk of continuing pregnancy is greater than delivery, or in some cases&#xD;
      electively after 39 weeks of gestation.&#xD;
&#xD;
      Prior to starting an induction of labor, a digital exam is performed to determine the status&#xD;
      of the cervix in terms of its dilatation, effacement, position, softness, and fetal station.&#xD;
      If the cervical status is considered favorable for labor, then generally oxytocin is started&#xD;
      to induce uterine contractions. If the cervix is not considered favorable, a method of&#xD;
      cervical ripening is employed to induce physical changes in the cervix that make it more&#xD;
      favorable for labor.&#xD;
&#xD;
      This process involves inflammatory infiltration and release of metalloproteases that degrade&#xD;
      collagen and result in cervical remodeling(3). The primary benefit of cervical ripening is&#xD;
      reducing the length of labor; however, some studies have suggested that it may lower the rate&#xD;
      of cesarean section(4,5). The Bishop score (see table 1) is used as a scoring tool to&#xD;
      determine the status of the cervix(6). Most studies define a score of 6 or less as an&#xD;
      unfavorable cervix, while a score of greater than 8 is favorable, and has a similar&#xD;
      probability of vaginal delivery to spontaneous labor(7).&#xD;
&#xD;
      Commonly used methods for cervical ripening include pharmacologic forms such as synthetic&#xD;
      prostaglandin E1 (PGE1, i.e. misoprostol) and prostaglandin E2 (PGE2, i.e. dinoprostone), or&#xD;
      mechanical ripening with balloon (i.e. Foley) catheters.&#xD;
&#xD;
      Quality improvement, increasing efficiency, and decreasing cost continue to be challenges for&#xD;
      individual hospitals and the entire health care system. Induction of labor, especially with&#xD;
      an unfavorable cervix, is associated with longer lengths of stay for patients, which results&#xD;
      in increased cost(8).&#xD;
&#xD;
      Foley catheters are a safe, inexpensive and effective option for cervical ripening. A study&#xD;
      by Sciscione et al in 2001 compared Foley bulb use in inpatient versus outpatient settings&#xD;
      and found the outpatient use to be as effective for cervical ripening. The primary objective&#xD;
      of this study was to compare efficacy of these two approaches and the outcomes were similar.&#xD;
      There were no cases of endomyometritis or chorioamnionitis(9). While they did report a&#xD;
      shorter amount of time in the hospital with outpatient management, this was not a primary&#xD;
      outcome of the study and they did not compare costs. Recently there has been an increased&#xD;
      focus on the costs of medical care and patient satisfaction. Consequently, these are&#xD;
      increasingly important outcomes that research needs to focus on. It is our hope that the&#xD;
      findings of our study will support the use of outpatient pre-induction of labor cervical&#xD;
      ripening and result in a more efficient use of resources and improved patient satisfaction.&#xD;
&#xD;
      The purpose of this study is to compare the use of a Foley catheter for cervical ripening in&#xD;
      the inpatient and outpatient setting, in order to evaluate the difference in the amount of&#xD;
      time spent on labor and delivery during induction of labor, as well as the difference in&#xD;
      costs. An important secondary outcome we plan to evaluate as well is patient satisfaction.&#xD;
      This will be a randomized controlled trial, with the study population being pregnant women at&#xD;
      ≥ 37 weeks of gestation undergoing induction of labor. The projected time-frame will be from&#xD;
      October 2016 to June 2018. The expected outcome is that outpatient cervical ripening with&#xD;
      Foley catheter use will result in shorter lengths of stay on labor and delivery and less cost&#xD;
      than inpatient Foley catheter use in patients undergoing induction of labor. Additionally, we&#xD;
      anticipate greater patient satisfaction with outpatient management.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Lack of enrollment&#xD;
  </why_stopped>
  <start_date type="Actual">January 4, 2017</start_date>
  <completion_date type="Actual">April 1, 2021</completion_date>
  <primary_completion_date type="Actual">April 1, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Subjects will be randomly assigned to either inpatient or outpatient cervical ripening with a Foley catheter.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Difference in time on labor and delivery</measure>
    <time_frame>(approximately) 2 days</time_frame>
    <description>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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Difference in cost</measure>
    <time_frame>(approximately 5 days)</time_frame>
    <description>To compare the difference in cost for hospitalization in patients undergoing inpatient versus outpatient cervical ripening with a transcervical Foley catheter.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Patient satisfaction</measure>
    <time_frame>(approximately 5 days)</time_frame>
    <description>Each subject is asked to complete a survey</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Provider satisfaction</measure>
    <time_frame>(approximately 3 years)</time_frame>
    <description>After enrollment is completed, providers will be surveyed on their satisfaction</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length of labor induction</measure>
    <time_frame>(approximately 3 days)</time_frame>
    <description>Total length of induction, including cervical ripening</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Type of delivery</measure>
    <time_frame>(approximately 3 days)</time_frame>
    <description>Vaginal delivery versus cesarean section</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maternal blood loss</measure>
    <time_frame>(approximately 3 days)</time_frame>
    <description>Total blood loss at delivery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Infection rates</measure>
    <time_frame>(approximately 5 days)</time_frame>
    <description>Maternal intrapartum and postpartum infections</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Apgar scores</measure>
    <time_frame>(approximately 10 minutes)</time_frame>
    <description>Neonatal Apgar scores at 1 and 5 minutes, and 10 minutes if reported</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Non-reassuring fetal heart tracings</measure>
    <time_frame>(approximately 3 days)</time_frame>
    <description>Any non-reassuring fetal monitoring during labor</description>
  </secondary_outcome>
  <other_outcome>
    <measure>NICU admission</measure>
    <time_frame>(approximately 5 days)</time_frame>
    <description>Any neonatal ICU admissions</description>
  </other_outcome>
  <other_outcome>
    <measure>Neonatal fever</measure>
    <time_frame>(approximately 5 days)</time_frame>
    <description>Any neonatal fever</description>
  </other_outcome>
  <other_outcome>
    <measure>Total time on pitocin</measure>
    <time_frame>(approximately 3 days)</time_frame>
    <description>Time on pitocin for induction</description>
  </other_outcome>
  <other_outcome>
    <measure>Maximum dose of pitocin</measure>
    <time_frame>(approximately 3 days)</time_frame>
    <description>Max dose</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Pregnancy Related</condition>
  <condition>Labor</condition>
  <condition>Induction</condition>
  <condition>Cervical Ripening</condition>
  <arm_group>
    <arm_group_label>Inpatient Foley catheter</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Outpatient Foley catheter</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Inpatient Foley catheter</intervention_name>
    <arm_group_label>Inpatient Foley catheter</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Outpatient Foley catheter</intervention_name>
    <arm_group_label>Outpatient Foley catheter</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Pregnancies at least 37 weeks' gestation, undergoing induction of labor, with an&#xD;
             unfavorable cervix, defined as a Bishop score ≤ 6&#xD;
&#xD;
          -  The fetus must be in the cephalic presentation&#xD;
&#xD;
          -  Indications for induction of labor include, but are not limited to, the following:&#xD;
&#xD;
               -  Elective induction of labor at 39 weeks' gestation&#xD;
&#xD;
               -  Intrauterine growth restriction&#xD;
&#xD;
               -  Chronic hypertension&#xD;
&#xD;
               -  Diabetes&#xD;
&#xD;
               -  Gestational diabetes&#xD;
&#xD;
               -  Prior stillbirth&#xD;
&#xD;
               -  Other medical indications for induction of labor, as deemed appropriate by the&#xD;
                  obstetric provider, such as Systemic Lupus Erythematosus, Cholestasis of&#xD;
                  Pregnancy etc.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Gestational hypertension&#xD;
&#xD;
          -  Preeclampsia&#xD;
&#xD;
          -  Non-reassuring fetal testing&#xD;
&#xD;
          -  Multi-fetal gestation&#xD;
&#xD;
          -  Oligohydramnios&#xD;
&#xD;
          -  Fetal anomaly&#xD;
&#xD;
          -  Less than 37 weeks&#xD;
&#xD;
          -  Bishop score &gt; 6&#xD;
&#xD;
          -  Ruptured membranes&#xD;
&#xD;
          -  Contraindication to vaginal delivery including: active Herpes lesion, HIV VL &gt;1000&#xD;
             copies/mL, placenta previa, vasa previa, breech presentation, prior classical cesarean&#xD;
             section or transfundal myomectomy&#xD;
&#xD;
          -  Poor access to telephone or transportation&#xD;
&#xD;
          -  Latex allergy&#xD;
&#xD;
          -  Any other condition for which the managing physician or investigator deem outpatient&#xD;
             management inappropriate.&#xD;
&#xD;
          -  Currently participating in another clinical trial&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Pregnant women</gender_description>
    <minimum_age>14 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Sinai Hospital of Baltimore</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21224</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Thomas Jefferson University</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19107</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <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.</citation>
    <PMID>25603115</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>26727629</PMID>
  </reference>
  <reference>
    <citation>Smith R. Parturition. N Engl J Med. 2007 Jan 18;356(3):271-83. doi: 10.1056/NEJMra061360. No abstract available.</citation>
    <PMID>17229954</PMID>
  </reference>
  <reference>
    <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;2014(6):CD003101. doi: 10.1002/14651858.CD003101.pub3.</citation>
    <PMID>24941907</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>22419277</PMID>
  </reference>
  <reference>
    <citation>BISHOP EH. PELVIC SCORING FOR ELECTIVE INDUCTION. Obstet Gynecol. 1964 Aug;24:266-8. No abstract available.</citation>
    <PMID>14199536</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>19623003</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>23410692</PMID>
  </reference>
  <reference>
    <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. doi: 10.1016/s0029-7844(01)01579-4.</citation>
    <PMID>11704164</PMID>
  </reference>
  <verification_date>April 2021</verification_date>
  <study_first_submitted>October 12, 2017</study_first_submitted>
  <study_first_submitted_qc>December 6, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 7, 2018</study_first_posted>
  <last_update_submitted>April 11, 2021</last_update_submitted>
  <last_update_submitted_qc>April 11, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">April 14, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>LifeBridge Health</investigator_affiliation>
    <investigator_full_name>Rebecca Pierce-Williams</investigator_full_name>
    <investigator_title>Resident physician</investigator_title>
  </responsible_party>
  <keyword>Foley</keyword>
  <keyword>Transcervical</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03769610
org study id: 2383
nct id: NCT03769610
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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.
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.
primary purpose: Treatment
masking: None (Open Label)
measure: Difference in time on labor and delivery
time frame: (approximately) 2 days
description: 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.
measure: Difference in cost
time frame: (approximately 5 days)
description: To compare the difference in cost for hospitalization in patients undergoing inpatient versus outpatient cervical ripening with a transcervical Foley catheter.
measure: Patient satisfaction
time frame: (approximately 5 days)
description: Each subject is asked to complete a survey
measure: Provider satisfaction
time frame: (approximately 3 years)
description: After enrollment is completed, providers will be surveyed on their satisfaction
measure: Length of labor induction
time frame: (approximately 3 days)
description: Total length of induction, including cervical ripening
measure: Type of delivery
time frame: (approximately 3 days)
description: Vaginal delivery versus cesarean section
measure: Maternal blood loss
time frame: (approximately 3 days)
description: Total blood loss at delivery
measure: Infection rates
time frame: (approximately 5 days)
description: Maternal intrapartum and postpartum infections
measure: Apgar scores
time frame: (approximately 10 minutes)
description: Neonatal Apgar scores at 1 and 5 minutes, and 10 minutes if reported
measure: Non-reassuring fetal heart tracings
time frame: (approximately 3 days)
description: Any non-reassuring fetal monitoring during labor
measure: NICU admission
time frame: (approximately 5 days)
description: Any neonatal ICU admissions
measure: Neonatal fever
time frame: (approximately 5 days)
description: Any neonatal fever
measure: Total time on pitocin
time frame: (approximately 3 days)
description: Time on pitocin for induction
measure: Maximum dose of pitocin
time frame: (approximately 3 days)
description: Max dose
arm group label: Inpatient Foley catheter
arm group type: Active Comparator
description: 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.
arm group label: Outpatient Foley catheter
arm group type: Experimental
description: 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.
intervention type: Other
intervention name: Inpatient Foley catheter
arm group label: Inpatient Foley catheter
intervention type: Other
intervention name: Outpatient Foley catheter
arm group label: Outpatient Foley catheter
criteria: 
gender: Female
gender based: Yes
gender description: Pregnant women
minimum age: 14 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
facility: 
country: United States
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.
PMID: 25603115
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.
PMID: 26727629
citation: Smith R. Parturition. N Engl J Med. 2007 Jan 18;356(3):271-83. doi: 10.1056/NEJMra061360. No abstract available.
PMID: 17229954
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;2014(6):CD003101. doi: 10.1002/14651858.CD003101.pub3.
PMID: 24941907
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.
PMID: 22419277
citation: BISHOP EH. PELVIC SCORING FOR ELECTIVE INDUCTION. Obstet Gynecol. 1964 Aug;24:266-8. No abstract available.
PMID: 14199536
citation: 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
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.
PMID: 23410692
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. doi: 10.1016/s0029-7844(01)01579-4.
PMID: 11704164
responsible party type: Principal Investigator
investigator affiliation: LifeBridge Health
investigator full name: Rebecca Pierce-Williams
investigator title: Resident physician
sharing ipd: No