<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/NCT02997345</url>
  </required_header>
  <id_info>
    <org_study_id>tpr072013</org_study_id>
    <nct_id>NCT02997345</nct_id>
  </id_info>
  <brief_title>PPROM Registry (Preterm Premature Rupture of Membranes)</brief_title>
  <official_title>Patient Registry for Women Diagnosed With Preterm Premature Rupture of Membranes or PPROM During Pregnancy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>American Alliance for pProm Support</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>American Alliance for pProm Support</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Preterm Premature Rupture of Membranes (PPROM) before 37 weeks of pregnancy is responsible&#xD;
      for 40% of preterm births in the United States. The PPROM Registry aims to identify possible&#xD;
      causes of PPROM, evaluate trends in expectant management, measure maternal and fetal care,&#xD;
      and to review short term and long term outcomes of affected pregnancies and births.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Detailed Description&#xD;
&#xD;
      Preterm Premature Rupture of Membranes (pProm) is a factor in 40% of preterm births. The&#xD;
      earlier in pregnancy pProm occurs, the greater the potential latency period. Threats to the&#xD;
      pregnancy include placental abruption, umbilical cord prolapse, infection, and insufficient&#xD;
      pulmonary development, and preterm delivery. Management of pProm may include immediate&#xD;
      delivery, induction, or expectant management.&#xD;
&#xD;
      It is still unclear what is considered best practice for the course of treatment in pProm&#xD;
      pregnancies and post- delivery care of pProm babies in Neonatal Intensive Care Units (NICU),&#xD;
      as well as the long term outcomes of pProm survivors. Unfortunately, there are few recent&#xD;
      studies available for review and those that exist often do not reflect the current treatments&#xD;
      or innovations that have taken place, especially in neonatal care. Many of the studies&#xD;
      available focusing on pProm have very small sample sizes, as well as very short follow-up&#xD;
      post-delivery, resulting in a wide range of reported outcomes, especially regarding the&#xD;
      morbidity and mortality associated with pProm.&#xD;
&#xD;
      The pProm registry is the first of its kind and will provide a large cohort of data for&#xD;
      study. The purpose of this registry is to better understand pregnancies and births impacted&#xD;
      by pProm. This includes how pProm is managed in pregnancy and in how pProm neonates are cared&#xD;
      for in the NICU; identifying trends in expectant management, and to detect short term and&#xD;
      long term outcomes of those affected.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date>July 2013</start_date>
  <completion_date type="Anticipated">December 2025</completion_date>
  <primary_completion_date type="Anticipated">December 2025</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Ecologic or Community</observational_model>
    <time_perspective>Other</time_perspective>
  </study_design_info>
  <target_duration>1 Year</target_duration>
  <primary_outcome>
    <measure>Early Neonatal Mortality Rate</measure>
    <time_frame>28 days post delivery</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Stillbirth / Perinatal Mortality Rate</measure>
    <time_frame>Upon delivery</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Review of Socio-Economic Factors in pProm</measure>
    <time_frame>Single assessment (observational) at conclusion of pregnancy +30 days, monitored for up to 100 months</time_frame>
  </other_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">3000</enrollment>
  <condition>Fetal Membranes, Premature Rupture</condition>
  <condition>Preterm Premature Rupture of the Membranes</condition>
  <condition>Oligohydramnios</condition>
  <condition>Premature Birth</condition>
  <arm_group>
    <arm_group_label>PPROM (Preterm Premature Rupture of Membranes)</arm_group_label>
    <description>PPROM / Preterm Premature Rupture of Membranes &lt;37 weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>There is no intervention associated with this study.</intervention_name>
    <description>There is no intervention associated with this study.</description>
    <arm_group_label>PPROM (Preterm Premature Rupture of Membranes)</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Women diagnosed with Preterm Premature Rupture of Membranes (PPROM) prior to 37 weeks of&#xD;
        pregnancy&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Women diagnosed with Preterm Premature Rupture of Membranes (PPROM) prior to 37 weeks&#xD;
             of pregnancy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Those without a clinical diagnosis or confirmation of PPROM in pregnancy&#xD;
&#xD;
          -  Diagnosis of PROM beyond 37 weeks of pregnancy&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>14 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Erin Thatcher</last_name>
    <phone>(740) 837-7766</phone>
  </overall_contact>
  <location>
    <facility>
      <name>Www.Aapprom.Org/the-Registry</name>
      <address>
        <city>Denver</city>
        <state>Colorado</state>
        <zip>80202</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Erin</last_name>
      <phone>740-837-7766</phone>
      <email>erin@aapprom.org</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <removed_countries>
    <country>United Kingdom</country>
  </removed_countries>
  <link>
    <url>https://www.aapprom.org/the-registry</url>
    <description>PPROM Registry</description>
  </link>
  <verification_date>February 2022</verification_date>
  <study_first_submitted>October 18, 2016</study_first_submitted>
  <study_first_submitted_qc>December 15, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 20, 2016</study_first_posted>
  <last_update_submitted>February 14, 2022</last_update_submitted>
  <last_update_submitted_qc>February 14, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">March 2, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>American Alliance for pProm Support</investigator_affiliation>
    <investigator_full_name>Erin Thatcher</investigator_full_name>
    <investigator_title>Director</investigator_title>
  </responsible_party>
  <keyword>PPROM</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Premature Birth</mesh_term>
    <mesh_term>Fetal Membranes, Premature Rupture</mesh_term>
    <mesh_term>Oligohydramnios</mesh_term>
    <mesh_term>Rupture</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT02997345
org study id: tpr072013
nct id: NCT02997345
lead sponsor: 
has dmc: Yes
Preterm Premature Rupture of Membranes (PPROM) before 37 weeks of pregnancy is responsible
      for 40% of preterm births in the United States. The PPROM Registry aims to identify possible
      causes of PPROM, evaluate trends in expectant management, measure maternal and fetal care,
      and to review short term and long term outcomes of affected pregnancies and births.
Detailed Description

      Preterm Premature Rupture of Membranes (pProm) is a factor in 40% of preterm births. The
      earlier in pregnancy pProm occurs, the greater the potential latency period. Threats to the
      pregnancy include placental abruption, umbilical cord prolapse, infection, and insufficient
      pulmonary development, and preterm delivery. Management of pProm may include immediate
      delivery, induction, or expectant management.

      It is still unclear what is considered best practice for the course of treatment in pProm
      pregnancies and post- delivery care of pProm babies in Neonatal Intensive Care Units (NICU),
      as well as the long term outcomes of pProm survivors. Unfortunately, there are few recent
      studies available for review and those that exist often do not reflect the current treatments
      or innovations that have taken place, especially in neonatal care. Many of the studies
      available focusing on pProm have very small sample sizes, as well as very short follow-up
      post-delivery, resulting in a wide range of reported outcomes, especially regarding the
      morbidity and mortality associated with pProm.

      The pProm registry is the first of its kind and will provide a large cohort of data for
      study. The purpose of this registry is to better understand pregnancies and births impacted
      by pProm. This includes how pProm is managed in pregnancy and in how pProm neonates are cared
      for in the NICU; identifying trends in expectant management, and to detect short term and
      long term outcomes of those affected.
observational model: Ecologic or Community
time perspective: Other
measure: Early Neonatal Mortality Rate
time frame: 28 days post delivery
measure: Stillbirth / Perinatal Mortality Rate
time frame: Upon delivery
measure: Review of Socio-Economic Factors in pProm
time frame: Single assessment (observational) at conclusion of pregnancy +30 days, monitored for up to 100 months
arm group label: PPROM (Preterm Premature Rupture of Membranes)
description: PPROM / Preterm Premature Rupture of Membranes <37 weeks
intervention type: Other
intervention name: There is no intervention associated with this study.
description: There is no intervention associated with this study.
arm group label: PPROM (Preterm Premature Rupture of Membranes)
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 14 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Erin Thatcher
phone: (740) 837-7766
facility: 
status: Recruiting
contact: 
country: United States
country: United Kingdom
url: https://www.aapprom.org/the-registry
description: PPROM Registry
responsible party type: Principal Investigator
investigator affiliation: American Alliance for pProm Support
investigator full name: Erin Thatcher
investigator title: Director
mesh term: Premature Birth
mesh term: Fetal Membranes, Premature Rupture
mesh term: Oligohydramnios
mesh term: Rupture
sharing ipd: Undecided