<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/NCT03267771</url>
  </required_header>
  <id_info>
    <org_study_id>gehad elsherief</org_study_id>
    <nct_id>NCT03267771</nct_id>
  </id_info>
  <brief_title>Progesterone and Doppler in Recurrent Abortion</brief_title>
  <official_title>Role of Serum Progesterone and Doppler Ultrasound in Prediction of Pregnancy Outcome in Women With Recurrent Unexplained Abortion</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assiut University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assiut University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Recurrent pregnancy loss is classically defined as the occurrence of three or more&#xD;
      consecutive pregnancy loss. The American Society of Reproductive Medicine has recently&#xD;
      redefined recurrent pregnancy loss as two or more pregnancy losses. A pregnancy loss is&#xD;
      defined as a clinically-recognized pregnancy means that the pregnancy has been visualized on&#xD;
      an ultrasound or that pregnancy tissue was identified after a pregnancy loss.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Spontaneous pregnancy loss is a surprisingly common occurrence. Whereas approximately 15% of&#xD;
      all clinically recognized pregnancies result in spontaneous loss, there are many more&#xD;
      pregnancies that fail prior to being clinically recognized. Only 30% of all conceptions&#xD;
      result in a live birth.&#xD;
&#xD;
      Although no reliable published data have estimated the probability of finding an etiology for&#xD;
      recurrent pregnancy loss in a population with 2 versus 3 or more miscarriages, the best&#xD;
      available data suggest that the risk of miscarriage in subsequent pregnancies is 30% after 2&#xD;
      losses, compared with 33% after 3 losses among patients without a history of a live birth.&#xD;
      This strongly suggests a role for evaluation after just 2 losses in patients with no prior&#xD;
      live births. An earlier evaluation may be further indicated if fetal cardiac activity was&#xD;
      identified prior to a loss .&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">October 1, 2017</start_date>
  <completion_date type="Anticipated">December 5, 2019</completion_date>
  <primary_completion_date type="Anticipated">August 5, 2019</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>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>number of Live births after 28 weeks of gestation</measure>
    <time_frame>28 weeks gestation</time_frame>
    <description>Live births that survive and continue beyond 28 weeks of gestation</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of patients who Tolerable with the treatment</measure>
    <time_frame>12 weeks</time_frame>
    <description>efficacy of treatment on patients</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Abortion in First Trimester</condition>
  <arm_group>
    <arm_group_label>progesterone suppositories vaginal group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>vaginal micronized progesterone suppositories (prontogest®) 400 mg, one vaginal suppository twice daily through 18 weeks of gestation.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Dydrogesterone oral tablets group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>20 mg tablets (Duphaston ®), 2 tablets orally twice daily through 18 weeks of gestation.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Progesterone Suppositories Vaginal</intervention_name>
    <description>progesterone vaginal suppository</description>
    <arm_group_label>progesterone suppositories vaginal group</arm_group_label>
    <other_name>Prontogest</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dydrogesterone Oral Tablet</intervention_name>
    <description>oral progesterone drug</description>
    <arm_group_label>Dydrogesterone oral tablets group</arm_group_label>
    <other_name>Duphaston</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>doppler ultrasound</intervention_name>
    <description>pulsed doppler ultrasound</description>
    <arm_group_label>Dydrogesterone oral tablets group</arm_group_label>
    <arm_group_label>progesterone suppositories vaginal group</arm_group_label>
    <other_name>Gomez et al</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. pregnant 7-12 weeks documented by pregnancy test &amp;/or ultrasaound.&#xD;
&#xD;
          2. History of at least 2 prior spontaneous abortion before 12 weeks of gestation.&#xD;
&#xD;
          3. Age: 18-35 years&#xD;
&#xD;
          4. Willing and able to give informed consent.&#xD;
&#xD;
          5. Rh +ve patient&#xD;
&#xD;
          6. BMI: 18-32&#xD;
&#xD;
          7. Viable pregnancy through the detection of fetal pulsations by ultrasound&#xD;
&#xD;
          8. Singleton pregnancy&#xD;
&#xD;
          9. Apparently stable pregnancy (no history of vaginal bleeding in this current pregnancy&#xD;
             or signs of sac separation in ultrasound)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients diagnosed to have Anti-phospholipid syndrome or another recognised&#xD;
             thrombophilic or autoimmune conditions.&#xD;
&#xD;
          2. Pregnant &gt; 12 weeks.&#xD;
&#xD;
          3. Contraindication to progesterone use.&#xD;
&#xD;
          4. Diabetic patients, have glucose intolerance.&#xD;
&#xD;
          5. Multiple pregnancies.&#xD;
&#xD;
          6. Thyroid disorder&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>35 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Ahmed Ibrahim</last_name>
    <phone>01000024321</phone>
    <email>ahmedibrahimhas@yahoo.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Hesham Abu taleb</last_name>
    <phone>01003332139</phone>
    <email>Hishamaboutaleb1@yahoo.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Gehad Elsherief</name>
      <address>
        <city>Assiut</city>
        <country>Egypt</country>
      </address>
    </facility>
    <contact>
      <last_name>gehad elsherief</last_name>
    </contact>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <reference>
    <citation>Macklon NS, Geraedts JP, Fauser BC. Conception to ongoing pregnancy: the 'black box' of early pregnancy loss. Hum Reprod Update. 2002 Jul-Aug;8(4):333-43. doi: 10.1093/humupd/8.4.333.</citation>
    <PMID>12206468</PMID>
  </reference>
  <reference>
    <citation>Sotiriadis A, Papatheodorou S, Makrydimas G. Threatened miscarriage: evaluation and management. BMJ. 2004 Jul 17;329(7458):152-5. doi: 10.1136/bmj.329.7458.152. No abstract available.</citation>
    <PMID>15258071</PMID>
  </reference>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>June 5, 2017</study_first_submitted>
  <study_first_submitted_qc>August 29, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 30, 2017</study_first_posted>
  <last_update_submitted>September 6, 2017</last_update_submitted>
  <last_update_submitted_qc>September 6, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 8, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Assiut University</investigator_affiliation>
    <investigator_full_name>GKElsherief</investigator_full_name>
    <investigator_title>prinicipal investigator</investigator_title>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Progesterone</mesh_term>
    <mesh_term>Dydrogesterone</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/NCT03267771
org study id: gehad elsherief
nct id: NCT03267771
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
is us export: No
Recurrent pregnancy loss is classically defined as the occurrence of three or more
      consecutive pregnancy loss. The American Society of Reproductive Medicine has recently
      redefined recurrent pregnancy loss as two or more pregnancy losses. A pregnancy loss is
      defined as a clinically-recognized pregnancy means that the pregnancy has been visualized on
      an ultrasound or that pregnancy tissue was identified after a pregnancy loss.
Spontaneous pregnancy loss is a surprisingly common occurrence. Whereas approximately 15% of
      all clinically recognized pregnancies result in spontaneous loss, there are many more
      pregnancies that fail prior to being clinically recognized. Only 30% of all conceptions
      result in a live birth.

      Although no reliable published data have estimated the probability of finding an etiology for
      recurrent pregnancy loss in a population with 2 versus 3 or more miscarriages, the best
      available data suggest that the risk of miscarriage in subsequent pregnancies is 30% after 2
      losses, compared with 33% after 3 losses among patients without a history of a live birth.
      This strongly suggests a role for evaluation after just 2 losses in patients with no prior
      live births. An earlier evaluation may be further indicated if fetal cardiac activity was
      identified prior to a loss .
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: number of Live births after 28 weeks of gestation
time frame: 28 weeks gestation
description: Live births that survive and continue beyond 28 weeks of gestation
measure: Number of patients who Tolerable with the treatment
time frame: 12 weeks
description: efficacy of treatment on patients
arm group label: progesterone suppositories vaginal group
arm group type: Active Comparator
description: vaginal micronized progesterone suppositories (prontogest®) 400 mg, one vaginal suppository twice daily through 18 weeks of gestation.
arm group label: Dydrogesterone oral tablets group
arm group type: Experimental
description: 20 mg tablets (Duphaston ®), 2 tablets orally twice daily through 18 weeks of gestation.
intervention type: Drug
intervention name: Progesterone Suppositories Vaginal
description: progesterone vaginal suppository
arm group label: progesterone suppositories vaginal group
other name: Prontogest
intervention type: Drug
intervention name: Dydrogesterone Oral Tablet
description: oral progesterone drug
arm group label: Dydrogesterone oral tablets group
other name: Duphaston
intervention type: Device
intervention name: doppler ultrasound
description: pulsed doppler ultrasound
arm group label: Dydrogesterone oral tablets group
arm group label: progesterone suppositories vaginal group
other name: Gomez et al
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 35 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Ahmed Ibrahim
phone: 01000024321
email: ahmedibrahimhas@yahoo.com
last name: Hesham Abu taleb
phone: 01003332139
email: Hishamaboutaleb1@yahoo.com
facility: 
contact: 
country: Egypt
citation: Macklon NS, Geraedts JP, Fauser BC. Conception to ongoing pregnancy: the 'black box' of early pregnancy loss. Hum Reprod Update. 2002 Jul-Aug;8(4):333-43. doi: 10.1093/humupd/8.4.333.
PMID: 12206468
citation: Sotiriadis A, Papatheodorou S, Makrydimas G. Threatened miscarriage: evaluation and management. BMJ. 2004 Jul 17;329(7458):152-5. doi: 10.1136/bmj.329.7458.152. No abstract available.
PMID: 15258071
responsible party type: Principal Investigator
investigator affiliation: Assiut University
investigator full name: GKElsherief
investigator title: prinicipal investigator
mesh term: Progesterone
mesh term: Dydrogesterone
sharing ipd: No