<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/NCT01670929</url>
  </required_header>
  <id_info>
    <org_study_id>PPROURM</org_study_id>
    <nct_id>NCT01670929</nct_id>
  </id_info>
  <brief_title>Pr-conceptional Progesterone for Unexplained Recurrent Miscarriage</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Woman's Health University Hospital, Egypt</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Woman's Health University Hospital, Egypt</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      In women with unexplained recurrent miscarriages, progesterone (400 mg pessaries, twice&#xD;
      daily), started soon as possible at luteal phase and after a positive pregnancy test and&#xD;
      continued to 28 weeks of gestation, compared to placebo, ).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Progesterone improves secondary outcomes such as gestation at delivery, on-going pregnancy at&#xD;
      12 weeks, survival at 28 days of neonatal life.&#xD;
&#xD;
      . Progesterone, compared to placebo, does not incur substantial adverse effects to the mother&#xD;
      or the neonate.&#xD;
&#xD;
      Explore differential or subgroup effects of progesterone in prognostic subgroups.&#xD;
&#xD;
      . Perform an economic evaluation for cost-effectiveness.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">November 2015</completion_date>
  <primary_completion_date type="Actual">May 2015</primary_completion_date>
  <phase>Phase 4</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>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of patients continued the pregnancy beyond 20 weeks gestation.</measure>
    <time_frame>2 years</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of miscarriages</measure>
    <time_frame>2 years</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Number of Live Birth</measure>
    <time_frame>2 years</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Number of preterm delivery</measure>
    <time_frame>2 years</time_frame>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">700</enrollment>
  <condition>Abortion, Habitual</condition>
  <arm_group>
    <arm_group_label>Progesterone group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>progesterone (400 mg pessary, once daily)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo (pessary, once daily)</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Progesterone</intervention_name>
    <arm_group_label>Progesterone group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <arm_group_label>Placebo group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Women with unexplained recurrent miscarriages (2 or more consecutive first trimester&#xD;
             miscarriages).&#xD;
&#xD;
          2. Age 18-39 years at randomisation (likelihood of miscarriages due to chromosomal&#xD;
             aberrations is higher in older women; such miscarriages are unlikely to be prevented&#xD;
             by progesterone therapy).&#xD;
&#xD;
          3. Spontaneous conception (as confirmed by urinary pregnancy tests).&#xD;
&#xD;
          4. Willing and able to give informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Age less than twenty or above forty years old.&#xD;
&#xD;
          2. Antiphospholipid syndrome (lupus anticoagulant and/or anticardiolipin antibodies [IgG&#xD;
             or IgM]); other recognised thrombophilic conditions (testing according to usual clinic&#xD;
             practice)&#xD;
&#xD;
          3. Intrauterine abnormalities (as assessed by ultrasound, hysterosonography,&#xD;
             hysterosalpingogram, or hysteroscopy).&#xD;
&#xD;
          4. Fibroids distorting uterine cavity.&#xD;
&#xD;
          5. Abnormal parental karyotype.&#xD;
&#xD;
          6. Other identifiable causes of recurrent miscarriages (tests initiated only if&#xD;
             clinically indicated) e.g., diabetes, thyroid disease and systemic lupus erythematosus&#xD;
             (SLE).&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>39 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Alaa M Ismail, M D</last_name>
    <role>Principal Investigator</role>
    <affiliation>Faculity of medicine,Assiut university</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Women's Health Hospital</name>
      <address>
        <city>Assiut</city>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>April 2016</verification_date>
  <study_first_submitted>August 17, 2012</study_first_submitted>
  <study_first_submitted_qc>August 21, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 22, 2012</study_first_posted>
  <last_update_submitted>April 3, 2016</last_update_submitted>
  <last_update_submitted_qc>April 3, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">April 5, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Woman's Health University Hospital, Egypt</investigator_affiliation>
    <investigator_full_name>alaa eldeen mahmoud ismail</investigator_full_name>
    <investigator_title>M D</investigator_title>
  </responsible_party>
  <keyword>recurrent miscarriages</keyword>
  <keyword>progesterone</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Abortion, Habitual</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Progesterone</mesh_term>
  </intervention_browse>
  <!-- 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/NCT01670929
org study id: PPROURM
nct id: NCT01670929
lead sponsor: 
has dmc: Yes
In women with unexplained recurrent miscarriages, progesterone (400 mg pessaries, twice
      daily), started soon as possible at luteal phase and after a positive pregnancy test and
      continued to 28 weeks of gestation, compared to placebo, ).
Progesterone improves secondary outcomes such as gestation at delivery, on-going pregnancy at
      12 weeks, survival at 28 days of neonatal life.

      . Progesterone, compared to placebo, does not incur substantial adverse effects to the mother
      or the neonate.

      Explore differential or subgroup effects of progesterone in prognostic subgroups.

      . Perform an economic evaluation for cost-effectiveness.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Number of patients continued the pregnancy beyond 20 weeks gestation.
time frame: 2 years
measure: Number of miscarriages
time frame: 2 years
measure: Number of Live Birth
time frame: 2 years
measure: Number of preterm delivery
time frame: 2 years
arm group label: Progesterone group
arm group type: Active Comparator
description: progesterone (400 mg pessary, once daily)
arm group label: Placebo group
arm group type: Placebo Comparator
description: Placebo (pessary, once daily)
intervention type: Drug
intervention name: Progesterone
arm group label: Progesterone group
intervention type: Other
intervention name: Placebo
arm group label: Placebo group
criteria: 
gender: Female
minimum age: 20 Years
maximum age: 39 Years
healthy volunteers: No
last name: Alaa M Ismail, M D
role: Principal Investigator
affiliation: Faculity of medicine,Assiut university
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Woman's Health University Hospital, Egypt
investigator full name: alaa eldeen mahmoud ismail
investigator title: M D
mesh term: Abortion, Habitual
mesh term: Progesterone