<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/NCT04496908</url>
  </required_header>
  <id_info>
    <org_study_id>DDD# 604698</org_study_id>
    <nct_id>NCT04496908</nct_id>
  </id_info>
  <brief_title>Early Versus Delayed Artificial Rupture of Membranes (AROM Trial)</brief_title>
  <acronym>AROM</acronym>
  <official_title>Early Versus Delayed Artificial Rupture of Membranes Following Foley Catheter Ripening in Labor Induction: A Randomized Controlled Trial (AROM Trial)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Christiana Care Health Services</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Christiana Care Health Services</source>
  <oversight_info>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This randomized controlled trial of consenting women undergoing induction of labor with&#xD;
      combined combination Foley catheter and pharmacologic cervical ripening seeks to efficacy of&#xD;
      early amniotomy.&#xD;
&#xD;
      This project will include 157 women presenting at Christiana Care Health System. Women will&#xD;
      be included if they are at least 37 weeks gestation, have a singleton pregnancy, have intact&#xD;
      membranes and are undergoing an induction of labor using a Foley catheter combined with&#xD;
      either misoprostol or pitocin. Following admission, women will be randomized into either&#xD;
      early or delayed amniotomy&#xD;
&#xD;
      Women will be randomized with equal probability to the intervention group using block&#xD;
      randomization stratified by party.&#xD;
&#xD;
      Prior to discharge from the hospital, baseline demographic and clinical data will be obtained&#xD;
      via chart review&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 16, 2020</start_date>
  <completion_date type="Actual">October 18, 2021</completion_date>
  <primary_completion_date type="Actual">May 22, 2021</primary_completion_date>
  <phase>Early Phase 1</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>time to delivery</measure>
    <time_frame>Number of hours from removal of Foley catheter to delivery of neonate; up to 72 hours.</time_frame>
    <description>time to delivery (hours) defined as time from Foley Catheter expulsion to delivery regardless of mode of delivery.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Cesarean delivery rate</measure>
    <time_frame>At time of delivery</time_frame>
    <description>binary; yes/no</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to vaginal delivery</measure>
    <time_frame>At time of delivery</time_frame>
    <description>time to delivery (hours) defined as time from Foley Catheter expulsion to delivery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maternal length of stay</measure>
    <time_frame>through study completion, an average of 4 days</time_frame>
    <description>time from admission to discharge</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Indication for cesarean delivery</measure>
    <time_frame>At time of delivery</time_frame>
    <description>discrete</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Chorioamnionitis</measure>
    <time_frame>At time of delivery</time_frame>
    <description>defined by the presence of maternal fever ≥100·4°f in the presence of maternal or fetal tachycardia or fundal tenderness</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>3rd/4th degree perineal laceration</measure>
    <time_frame>at time of delivery</time_frame>
    <description>binary; yes/no</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood transfusion</measure>
    <time_frame>through study completion, an average of 1 year</time_frame>
    <description>binary; yes/no</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Endometritis</measure>
    <time_frame>From time of delivery to time of hospital discharge; up to 6 weeks</time_frame>
    <description>binary; yes/no</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Wound separation-infection</measure>
    <time_frame>through study completion, an average of 1 year</time_frame>
    <description>binary, yes/no; defined by the need for additional wound closure or the need for antibiotics</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Neonatal death</measure>
    <time_frame>through study completion, an average of 1 year</time_frame>
    <description>binary, yes/no</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">160</enrollment>
  <condition>Induction of Labor Affected Fetus / Newborn</condition>
  <arm_group>
    <arm_group_label>Early Amniotomy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Women in the Early AROM group will under amniotomy one hour from Foley Catheter expulsion. Labor augmentation will continue per study protocol. Refer to Appendix A for protocol regimen.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Delayed Amniotomy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Women in the Delayed AROM group will undergo amniotomy at the discretion of the obstetrician or labor provider. No specific instructions will be given.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>amniotomy</intervention_name>
    <description>Artificially rupturing membranes</description>
    <arm_group_label>Delayed Amniotomy</arm_group_label>
    <arm_group_label>Early Amniotomy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Foley Catheter</intervention_name>
    <description>Foley catheter device is commonly used for cervical ripening during labor induction. It is used independently or in combination with pharmacologic augmentation. It is inserted in the cervix and the balloon is then inflated with 60 cc of saline.</description>
    <arm_group_label>Delayed Amniotomy</arm_group_label>
    <arm_group_label>Early Amniotomy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Misoprostol</intervention_name>
    <description>Misoprostol is a medication that is commonly used for cervical ripening during labor induction. It is commonly used independently or in combination with mechanical methods, such as a foley catheter. The commonly used dose during term labor induction is 25 mcg.</description>
    <arm_group_label>Delayed Amniotomy</arm_group_label>
    <arm_group_label>Early Amniotomy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  ≥18 years of age&#xD;
&#xD;
          -  full term (≥37 weeks) gestations determined by routine obstetrical guidelines&#xD;
&#xD;
          -  singleton gestation in cephalic presentation&#xD;
&#xD;
          -  Both nulliparous and multiparous women&#xD;
&#xD;
          -  Intact membranes&#xD;
&#xD;
          -  Bishop score of ≤6 and cervical dilation ≤2cm&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any contraindication to a vaginal delivery or to misoprostol&#xD;
&#xD;
          -  fetal demise&#xD;
&#xD;
          -  Multifetal gestation&#xD;
&#xD;
          -  major fetal anomaly&#xD;
&#xD;
          -  prior uterine surgery, previous cesarean section&#xD;
&#xD;
          -  women with HIV, hepatitis C, hepatitis B, and women with medical conditions requiring&#xD;
             an assisted second stage&#xD;
&#xD;
          -  Additional exclusion criteria were as follows: category 3 fetal heart rate tracing,&#xD;
             hemolysis elevated liver enzymes and low platelets (HELLP) syndrome or eclampsia,&#xD;
             growth restriction &lt;10th percentile (based on Hadlock growth curves) with reversal of&#xD;
             flow in umbilical artery Doppler studies, and growth restriction &lt;5th percentile with&#xD;
             elevated, absent, or reversal of flow in umbilical artery Doppler studies.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Christiana Care Health Systems</name>
      <address>
        <city>Newark</city>
        <state>Delaware</state>
        <zip>19713</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Wei S, Wo BL, Qi HP, Xu H, Luo ZC, Roy C, Fraser WD. Early amniotomy and early oxytocin for prevention of, or therapy for, delay in first stage spontaneous labour compared with routine care. Cochrane Database Syst Rev. 2013 Aug 7;(8):CD006794. doi: 10.1002/14651858.CD006794.pub4.</citation>
    <PMID>23926074</PMID>
  </reference>
  <reference>
    <citation>Macones GA, Cahill A, Stamilio DM, Odibo AO. The efficacy of early amniotomy in nulliparous labor induction: a randomized controlled trial. Am J Obstet Gynecol. 2012 Nov;207(5):403.e1-5. doi: 10.1016/j.ajog.2012.08.032. Epub 2012 Aug 24.</citation>
    <PMID>22959833</PMID>
  </reference>
  <reference>
    <citation>Levy R, Ferber A, Ben-Arie A, Paz B, Hazan Y, Blickstein I, Hagay ZJ. A randomised comparison of early versus late amniotomy following cervical ripening with a Foley catheter. BJOG. 2002 Feb;109(2):168-72. doi: 10.1111/j.1471-0528.2002.01137.x.</citation>
    <PMID>11888099</PMID>
  </reference>
  <reference>
    <citation>Levine LD, Downes KL, Elovitz MA, Parry S, Sammel MD, Srinivas SK. Mechanical and Pharmacologic Methods of Labor Induction: A Randomized Controlled Trial. Obstet Gynecol. 2016 Dec;128(6):1357-1364. doi: 10.1097/AOG.0000000000001778.</citation>
    <PMID>27824758</PMID>
  </reference>
  <reference>
    <citation>Delaney S, Shaffer BL, Cheng YW, Vargas J, Sparks TN, Paul K, Caughey AB. Labor induction with a Foley balloon inflated to 30 mL compared with 60 mL: a randomized controlled trial. Obstet Gynecol. 2010 Jun;115(6):1239-1245. doi: 10.1097/AOG.0b013e3181dec6d0.</citation>
    <PMID>20502296</PMID>
  </reference>
  <verification_date>November 2021</verification_date>
  <study_first_submitted>July 27, 2020</study_first_submitted>
  <study_first_submitted_qc>July 29, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 4, 2020</study_first_posted>
  <last_update_submitted>November 22, 2021</last_update_submitted>
  <last_update_submitted_qc>November 22, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">December 3, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Christiana Care Health Services</investigator_affiliation>
    <investigator_full_name>Helen Beatriz Gomez</investigator_full_name>
    <investigator_title>Resident Physician</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Rupture</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Misoprostol</mesh_term>
  </intervention_browse>
  <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/NCT04496908
org study id: DDD# 604698
nct id: NCT04496908
lead sponsor: 
is fda regulated drug: Yes
is fda regulated device: No
This randomized controlled trial of consenting women undergoing induction of labor with
      combined combination Foley catheter and pharmacologic cervical ripening seeks to efficacy of
      early amniotomy.

      This project will include 157 women presenting at Christiana Care Health System. Women will
      be included if they are at least 37 weeks gestation, have a singleton pregnancy, have intact
      membranes and are undergoing an induction of labor using a Foley catheter combined with
      either misoprostol or pitocin. Following admission, women will be randomized into either
      early or delayed amniotomy

      Women will be randomized with equal probability to the intervention group using block
      randomization stratified by party.

      Prior to discharge from the hospital, baseline demographic and clinical data will be obtained
      via chart review
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: time to delivery
time frame: Number of hours from removal of Foley catheter to delivery of neonate; up to 72 hours.
description: time to delivery (hours) defined as time from Foley Catheter expulsion to delivery regardless of mode of delivery.
measure: Cesarean delivery rate
time frame: At time of delivery
description: binary; yes/no
measure: Time to vaginal delivery
time frame: At time of delivery
description: time to delivery (hours) defined as time from Foley Catheter expulsion to delivery
measure: Maternal length of stay
time frame: through study completion, an average of 4 days
description: time from admission to discharge
measure: Indication for cesarean delivery
time frame: At time of delivery
description: discrete
measure: Chorioamnionitis
time frame: At time of delivery
description: defined by the presence of maternal fever ≥100·4°f in the presence of maternal or fetal tachycardia or fundal tenderness
measure: 3rd/4th degree perineal laceration
time frame: at time of delivery
description: binary; yes/no
measure: Blood transfusion
time frame: through study completion, an average of 1 year
description: binary; yes/no
measure: Endometritis
time frame: From time of delivery to time of hospital discharge; up to 6 weeks
description: binary; yes/no
measure: Wound separation-infection
time frame: through study completion, an average of 1 year
description: binary, yes/no; defined by the need for additional wound closure or the need for antibiotics
measure: Neonatal death
time frame: through study completion, an average of 1 year
description: binary, yes/no
arm group label: Early Amniotomy
arm group type: Active Comparator
description: Women in the Early AROM group will under amniotomy one hour from Foley Catheter expulsion. Labor augmentation will continue per study protocol. Refer to Appendix A for protocol regimen.
arm group label: Delayed Amniotomy
arm group type: Active Comparator
description: Women in the Delayed AROM group will undergo amniotomy at the discretion of the obstetrician or labor provider. No specific instructions will be given.
intervention type: Procedure
intervention name: amniotomy
description: Artificially rupturing membranes
arm group label: Delayed Amniotomy
arm group label: Early Amniotomy
intervention type: Device
intervention name: Foley Catheter
description: Foley catheter device is commonly used for cervical ripening during labor induction. It is used independently or in combination with pharmacologic augmentation. It is inserted in the cervix and the balloon is then inflated with 60 cc of saline.
arm group label: Delayed Amniotomy
arm group label: Early Amniotomy
intervention type: Drug
intervention name: Misoprostol
description: Misoprostol is a medication that is commonly used for cervical ripening during labor induction. It is commonly used independently or in combination with mechanical methods, such as a foley catheter. The commonly used dose during term labor induction is 25 mcg.
arm group label: Delayed Amniotomy
arm group label: Early Amniotomy
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: No
facility: 
country: United States
citation: Wei S, Wo BL, Qi HP, Xu H, Luo ZC, Roy C, Fraser WD. Early amniotomy and early oxytocin for prevention of, or therapy for, delay in first stage spontaneous labour compared with routine care. Cochrane Database Syst Rev. 2013 Aug 7;(8):CD006794. doi: 10.1002/14651858.CD006794.pub4.
PMID: 23926074
citation: Macones GA, Cahill A, Stamilio DM, Odibo AO. The efficacy of early amniotomy in nulliparous labor induction: a randomized controlled trial. Am J Obstet Gynecol. 2012 Nov;207(5):403.e1-5. doi: 10.1016/j.ajog.2012.08.032. Epub 2012 Aug 24.
PMID: 22959833
citation: Levy R, Ferber A, Ben-Arie A, Paz B, Hazan Y, Blickstein I, Hagay ZJ. A randomised comparison of early versus late amniotomy following cervical ripening with a Foley catheter. BJOG. 2002 Feb;109(2):168-72. doi: 10.1111/j.1471-0528.2002.01137.x.
PMID: 11888099
citation: Levine LD, Downes KL, Elovitz MA, Parry S, Sammel MD, Srinivas SK. Mechanical and Pharmacologic Methods of Labor Induction: A Randomized Controlled Trial. Obstet Gynecol. 2016 Dec;128(6):1357-1364. doi: 10.1097/AOG.0000000000001778.
PMID: 27824758
citation: Delaney S, Shaffer BL, Cheng YW, Vargas J, Sparks TN, Paul K, Caughey AB. Labor induction with a Foley balloon inflated to 30 mL compared with 60 mL: a randomized controlled trial. Obstet Gynecol. 2010 Jun;115(6):1239-1245. doi: 10.1097/AOG.0b013e3181dec6d0.
PMID: 20502296
responsible party type: Principal Investigator
investigator affiliation: Christiana Care Health Services
investigator full name: Helen Beatriz Gomez
investigator title: Resident Physician
mesh term: Rupture
mesh term: Misoprostol
sharing ipd: No