<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/NCT04478942</url>
  </required_header>
  <id_info>
    <org_study_id>UPH-Meriter IRB 2020-003</org_study_id>
    <secondary_id>A532860</secondary_id>
    <secondary_id>SMPH/OBSTET &amp; GYNECOL</secondary_id>
    <secondary_id>Protocol Version 1/29/2020</secondary_id>
    <secondary_id>2020-0240</secondary_id>
    <nct_id>NCT04478942</nct_id>
  </id_info>
  <brief_title>PROMMO Trial: Oral Misoprostol vs IV Oxytocin</brief_title>
  <acronym>PROMMO</acronym>
  <official_title>PROMMO Trial: Prelabor Rupture of Membranes Managed With Oral Misoprostol Versus Intravenous Oxytocin</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Wisconsin, Madison</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Wisconsin, Madison</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a prospective, randomized trial looking at the ideal method of labor induction for&#xD;
      women with prelabor rupture of membranes and an unfavorable cervical Bishop score. The study&#xD;
      will compare oral misoprostol and intravenous oxytocin.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of this study is to look at optimal induction management of prelabor rupture of&#xD;
      membranes (PROM) at or beyond 34 weeks gestational age.&#xD;
&#xD;
      Objective 1: To determine if there is a decrease in time from initiation of induction of&#xD;
      labor to vaginal delivery in women with an unfavorable cervix with the use of oral&#xD;
      misoprostol versus intravenous oxytocin.&#xD;
&#xD;
      Hypothesis: Cervical ripening with misoprostol will be beneficial in women with an&#xD;
      unfavorable cervix.&#xD;
&#xD;
      Sub objective 1: To determine if the use of oral misoprostol for cervical ripening decreases&#xD;
      the rate of postpartum hemorrhage in women with PROM.&#xD;
&#xD;
      Hypothesis: Misoprostol use will result in significantly lower rate of postpartum hemorrhage.&#xD;
&#xD;
      Sub objective 2: To evaluate the rates of infectious morbidity in peripartum women and&#xD;
      neonates exposed to misoprostol versus oxytocin in PROM.&#xD;
&#xD;
      Hypothesis: The use of oral misoprostol will result in lower rates of infectious morbidity in&#xD;
      mother and neonate.&#xD;
&#xD;
      Sub objective 3: To analyze patient satisfaction surveys. Hypothesis: Patients in the oral&#xD;
      misoprostol group will be more satisfied with their labor experience.&#xD;
&#xD;
      Exploratory Outcome To determine if there is a difference in cost between induction of labor&#xD;
      in women with an unfavorable cervix with the use of oral misoprostol versus intravenous&#xD;
      oxytocin.&#xD;
&#xD;
      Hypothesis: The use of oral misoprostol will be cost effective in women presenting with PROM&#xD;
      and an unfavorable cervix.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">October 26, 2020</start_date>
  <completion_date type="Anticipated">December 2023</completion_date>
  <primary_completion_date type="Anticipated">December 2023</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>Primary Endpoint: Time from initial medication administration to vaginal delivery</measure>
    <time_frame>Up to 72 hours</time_frame>
    <description>time from initiation of induction of labor to vaginal delivery in women with an unfavorable cervix with the use of oral misoprostol versus intravenous oxytocin</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Secondary endpoint 1: Rate of Postpartum Hemorrhage</measure>
    <time_frame>up to 24 hours for immediate postpartum hemorrhage</time_frame>
    <description>the rate of postpartum hemorrhage in women with prelabor rupture of membranes with use of oral misoprostol for cervical ripening</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Secondary endpoint 2: Rate of Suspected or Confirmed Intrapartum Intramniotic Infection</measure>
    <time_frame>Prior to delivery</time_frame>
    <description>Rates of infectious morbidity in peripartum women and neonates exposed to misoprostol versus oxytocin in prelabor rupture of membranes.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Secondary endpoint 3: Rate of Suspected Endometritis</measure>
    <time_frame>From delivery to 6 weeks postpartum</time_frame>
    <description>patient satisfaction surveys</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Secondary endpoint 4: Rate of Infectious Morbidity for Neonates</measure>
    <time_frame>up to 6 weeks of life</time_frame>
    <description>Neonatal infection that is diagnosed within the first 6 weeks of life related to maternal infection diagnosed by positive blood cultures or fever.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Secondary endpoint 5: Participant Satisfaction as Measured by modified Labour Agentry Scale</measure>
    <time_frame>Postpartum day one with repeat instrument at 6 weeks postpartum</time_frame>
    <description>The modified labour agentry scale has scores that indicate satisfaction with the patient's experience in labor</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Premature Rupture of Membrane</condition>
  <condition>Induction of Labor Affected Fetus / Newborn</condition>
  <arm_group>
    <arm_group_label>oral misoprostol</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>At time of delivery, participants randomly assigned to either oral misoprostol will receive 50 mcg of Misoprostol every 4 hours up to 6 doses, OR until simplified Bishop score &gt;6 (whichever is achieved first).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>intravenous oxytocin</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>At time of delivery, participants randomly assigned to intravenous oxytocin, will be administered the drug per standard of labor and delivery titrations.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Misoprostol Oral Product</intervention_name>
    <description>Misoprostol will be dosed using the preexisting UnityPoint Health-Meriter Protocol for oral misoprostol administration.</description>
    <arm_group_label>oral misoprostol</arm_group_label>
    <other_name>Oral Product</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Intravenous Oxytocin</intervention_name>
    <description>Intravenous oxytocin administration will also follow standard, UnityPoint Health-Meriter Protocol.</description>
    <arm_group_label>intravenous oxytocin</arm_group_label>
    <other_name>IV Product</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Early Term to late term pregnancy (&gt;37 weeks and 0 days and &lt;42 weeks and 0 days)&#xD;
&#xD;
          -  Late Preterm Pregnancy (34 weeks and 0 days and &lt;37 weeks)&#xD;
&#xD;
          -  Confirmed rupture of membranes by either sterile speculum exam or AmniSure&#xD;
&#xD;
          -  Simplified Bishop Score ≤ 6&#xD;
&#xD;
          -  Maternal Age &gt; 18 years old&#xD;
&#xD;
          -  Singleton gestation&#xD;
&#xD;
          -  Appropriate gestational age dating by certain LMP or ultrasound performed prior to 20&#xD;
             weeks gestational age&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Concern for intra-amniotic infection&#xD;
&#xD;
          -  Previous Cesarean delivery&#xD;
&#xD;
          -  Lack of appropriate dating criteria for the pregnancy&#xD;
&#xD;
          -  Inability to give informed consent in the patient's native language&#xD;
&#xD;
          -  Known bleeding disorder such as von Willebrand's disease or hemophilia&#xD;
&#xD;
          -  Anticoagulation administration within 24 hours of delivery&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jacquelyn Adams, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Wisconsin, Madison</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Sharon E Blohowiak, MS</last_name>
    <phone>608-417-6957</phone>
    <email>sblohowiak@wisc.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Jacquelyn Adams, MD</last_name>
    <phone>(608) 417-7427</phone>
    <email>jadams@uwhealth.org</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>UnityPoint Health- Meriter Hospital</name>
      <address>
        <city>Madison</city>
        <state>Wisconsin</state>
        <zip>53705-2216</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jacquelyn Adams</last_name>
      <phone>608-417-7427</phone>
      <email>jadams@uwhealth.org</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2022</verification_date>
  <study_first_submitted>July 15, 2020</study_first_submitted>
  <study_first_submitted_qc>July 15, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 21, 2020</study_first_posted>
  <last_update_submitted>December 8, 2022</last_update_submitted>
  <last_update_submitted_qc>December 8, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">December 9, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fetal Membranes, Premature Rupture</mesh_term>
    <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>
    <mesh_term>Oxytocin</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/NCT04478942
org study id: UPH-Meriter IRB 2020-003
secondary id: A532860
secondary id: SMPH/OBSTET & GYNECOL
secondary id: Protocol Version 1/29/2020
secondary id: 2020-0240
nct id: NCT04478942
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
is us export: Yes
This is a prospective, randomized trial looking at the ideal method of labor induction for
      women with prelabor rupture of membranes and an unfavorable cervical Bishop score. The study
      will compare oral misoprostol and intravenous oxytocin.
The purpose of this study is to look at optimal induction management of prelabor rupture of
      membranes (PROM) at or beyond 34 weeks gestational age.

      Objective 1: To determine if there is a decrease in time from initiation of induction of
      labor to vaginal delivery in women with an unfavorable cervix with the use of oral
      misoprostol versus intravenous oxytocin.

      Hypothesis: Cervical ripening with misoprostol will be beneficial in women with an
      unfavorable cervix.

      Sub objective 1: To determine if the use of oral misoprostol for cervical ripening decreases
      the rate of postpartum hemorrhage in women with PROM.

      Hypothesis: Misoprostol use will result in significantly lower rate of postpartum hemorrhage.

      Sub objective 2: To evaluate the rates of infectious morbidity in peripartum women and
      neonates exposed to misoprostol versus oxytocin in PROM.

      Hypothesis: The use of oral misoprostol will result in lower rates of infectious morbidity in
      mother and neonate.

      Sub objective 3: To analyze patient satisfaction surveys. Hypothesis: Patients in the oral
      misoprostol group will be more satisfied with their labor experience.

      Exploratory Outcome To determine if there is a difference in cost between induction of labor
      in women with an unfavorable cervix with the use of oral misoprostol versus intravenous
      oxytocin.

      Hypothesis: The use of oral misoprostol will be cost effective in women presenting with PROM
      and an unfavorable cervix.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Primary Endpoint: Time from initial medication administration to vaginal delivery
time frame: Up to 72 hours
description: time from initiation of induction of labor to vaginal delivery in women with an unfavorable cervix with the use of oral misoprostol versus intravenous oxytocin
measure: Secondary endpoint 1: Rate of Postpartum Hemorrhage
time frame: up to 24 hours for immediate postpartum hemorrhage
description: the rate of postpartum hemorrhage in women with prelabor rupture of membranes with use of oral misoprostol for cervical ripening
measure: Secondary endpoint 2: Rate of Suspected or Confirmed Intrapartum Intramniotic Infection
time frame: Prior to delivery
description: Rates of infectious morbidity in peripartum women and neonates exposed to misoprostol versus oxytocin in prelabor rupture of membranes.
measure: Secondary endpoint 3: Rate of Suspected Endometritis
time frame: From delivery to 6 weeks postpartum
description: patient satisfaction surveys
measure: Secondary endpoint 4: Rate of Infectious Morbidity for Neonates
time frame: up to 6 weeks of life
description: Neonatal infection that is diagnosed within the first 6 weeks of life related to maternal infection diagnosed by positive blood cultures or fever.
measure: Secondary endpoint 5: Participant Satisfaction as Measured by modified Labour Agentry Scale
time frame: Postpartum day one with repeat instrument at 6 weeks postpartum
description: The modified labour agentry scale has scores that indicate satisfaction with the patient's experience in labor
arm group label: oral misoprostol
arm group type: Active Comparator
description: At time of delivery, participants randomly assigned to either oral misoprostol will receive 50 mcg of Misoprostol every 4 hours up to 6 doses, OR until simplified Bishop score >6 (whichever is achieved first).
arm group label: intravenous oxytocin
arm group type: Active Comparator
description: At time of delivery, participants randomly assigned to intravenous oxytocin, will be administered the drug per standard of labor and delivery titrations.
intervention type: Drug
intervention name: Misoprostol Oral Product
description: Misoprostol will be dosed using the preexisting UnityPoint Health-Meriter Protocol for oral misoprostol administration.
arm group label: oral misoprostol
other name: Oral Product
intervention type: Drug
intervention name: Intravenous Oxytocin
description: Intravenous oxytocin administration will also follow standard, UnityPoint Health-Meriter Protocol.
arm group label: intravenous oxytocin
other name: IV Product
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Jacquelyn Adams, MD
role: Principal Investigator
affiliation: University of Wisconsin, Madison
last name: Sharon E Blohowiak, MS
phone: 608-417-6957
email: sblohowiak@wisc.edu
last name: Jacquelyn Adams, MD
phone: (608) 417-7427
email: jadams@uwhealth.org
facility: 
status: Recruiting
contact: 
country: United States
responsible party type: Sponsor
mesh term: Fetal Membranes, Premature Rupture
mesh term: Rupture
mesh term: Misoprostol
mesh term: Oxytocin
sharing ipd: No