<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/NCT03797508</url>
  </required_header>
  <id_info>
    <org_study_id>us laboratory miscarriage</org_study_id>
    <nct_id>NCT03797508</nct_id>
  </id_info>
  <brief_title>Biochemical Versus Ultrasound Findings as Predictors of Fetal Loss in Cases of First Trimester Threatened Miscarriage</brief_title>
  <official_title>Biochemical Versus Ultrasound Findings as Predictors of Fetal Loss in Cases of First Trimester Threatened Miscarriage</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ain Shams University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ain Shams University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Threatened miscarriage occurs in about one-fifth of pregnancies with an estimated miscarriage&#xD;
      rate of 3-16% after successful demonstration of fetal cardiac activity. Various biochemical&#xD;
      markers have been studied previously to predict the outcome of threatened miscarriage;&#xD;
      However, the results have been conflicting. Several studies have documented that a slow&#xD;
      embryonic heart rate at 6.0-7.0 Weeks' gestation is associated with a high rate of first&#xD;
      trimester fetal demise.&#xD;
&#xD;
      our aim: To evaluate the accuracy of ultrasound findings in comparison to serum CA125 and&#xD;
      progesterone in predicting fetal demise in cases of first trimester threatened miscarriage.&#xD;
&#xD;
      Will this pregnancy be continued after the first trimester or not?&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      we are comparing between the accuracy of vaginal ultra sound versus serum progesterone level&#xD;
      and serum CA 125 level in predicting of fetal demise in cases of threatened miscarriage three&#xD;
      vaginal ultrasounds will be done ) the first one will be done at six to eight weeks of&#xD;
      pregnancy to the patients who fulfill the criteria in this us we will make sure that the&#xD;
      cardiac pulsations are present and measure the following:&#xD;
&#xD;
        1. the fetal heart rate,&#xD;
&#xD;
        2. the crown rump length&#xD;
&#xD;
        3. gestational sac diameter&#xD;
&#xD;
        4. yolk sac diameter. b) The second ultra sound will be after two weeks from the first one&#xD;
           to follow up the patient for pregnancy survival, take the same measures again and&#xD;
           correlate them with the results of laboratory investigations to select the investigation&#xD;
           which is most accurate in anticipating outcome in cases of threatened abortion.&#xD;
&#xD;
      C) the third one will be at the end of first trimester (13 weeks) to ensure fetal viability.&#xD;
&#xD;
      . embryonic bradycardia and absence of yolk sac or smaller yolk sac than expected for any&#xD;
      given gestational age are prognostic factors of poor pregnancy outcome in the first 12 weeks&#xD;
      of pregnancy women with small for age gestational sac are more prone to have miscarriage we&#xD;
      will do laboratory investigation in the form of A) Serum progesterone: low maternal P levels&#xD;
      have been useful in predicting spontaneous abortion in threatened pregnancies with a&#xD;
      sensitivity of 80% (&lt;10 ng /mL) so, this will be our cutoff value. B) Serum CA 125 :we will&#xD;
      take a level of 51.5 as cut off value.this is the upper level of normal we will do them once&#xD;
      when the patient presents to us.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">December 1, 2018</start_date>
  <completion_date type="Anticipated">September 30, 2019</completion_date>
  <primary_completion_date type="Anticipated">May 31, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>ultra sound</measure>
    <time_frame>the 12th week of gestation</time_frame>
    <description>presence of fetal heart rate</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">42</enrollment>
  <condition>Abortion Threatened</condition>
  <arm_group>
    <arm_group_label>threatened miscarriage</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>ultrasound ,CA125,progesterone</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>ultrasound</intervention_name>
    <description>To evaluate the accuracy of ultrasound findings in comparison to serum CA125and progesterone in predicting fetal demise in cases of first trimester threatened miscarriage.</description>
    <arm_group_label>threatened miscarriage</arm_group_label>
    <other_name>progesterone</other_name>
    <other_name>CA125</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Singleton Pregnancy.&#xD;
&#xD;
          -  Age20-35years.&#xD;
&#xD;
          -  Gestational age between6 to 8weeks.&#xD;
&#xD;
          -  Threatened miscarriage is diagnosed by vaginal bleeding, closed cervix and positive&#xD;
             fetal life.&#xD;
&#xD;
          -  Patients who are sure of their dates (three regular menstrual cycles before conception&#xD;
             without the use of hormonal contraception.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Patients with recurrent miscarriage or pregnancy of unknown location (PUL).&#xD;
&#xD;
          -  Patients had ovulation induction medications or on progesterone treatment.&#xD;
&#xD;
          -  Patients with past medical history of diabetes mellitus or chronic hypertension.&#xD;
&#xD;
          -  Patients who are unsure of the last menstrual period date or with irregular menstrual&#xD;
             cycle.&#xD;
&#xD;
          -  Pregnancy associated with presence of ovarian cyst.&#xD;
&#xD;
          -  Molar pregnancy.&#xD;
&#xD;
          -  Those who had a history of maternal disease which would cause an increase in&#xD;
             CA-125level. These diseases include chronic pelvic infection, endometriosis, myoma&#xD;
             uteri, endometrioma and lung, kidney and hepatic diseases.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>35 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>amany a mahmoud</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ain Shams University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>mohamed k abdelwahab, master</last_name>
    <phone>01000849822</phone>
    <phone_ext>002</phone_ext>
    <email>m.k.ali1987@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Ain Shams University</name>
      <address>
        <city>Cairo</city>
        <country>Egypt</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>January 6, 2019</study_first_submitted>
  <study_first_submitted_qc>January 6, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 9, 2019</study_first_posted>
  <last_update_submitted>February 2, 2019</last_update_submitted>
  <last_update_submitted_qc>February 2, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 5, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ain Shams University</investigator_affiliation>
    <investigator_full_name>amany abdel monem mahmoud</investigator_full_name>
    <investigator_title>Egypt Cairo</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Abortion, Spontaneous</mesh_term>
    <mesh_term>Abortion, Threatened</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/NCT03797508
org study id: us laboratory miscarriage
nct id: NCT03797508
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Threatened miscarriage occurs in about one-fifth of pregnancies with an estimated miscarriage
      rate of 3-16% after successful demonstration of fetal cardiac activity. Various biochemical
      markers have been studied previously to predict the outcome of threatened miscarriage;
      However, the results have been conflicting. Several studies have documented that a slow
      embryonic heart rate at 6.0-7.0 Weeks' gestation is associated with a high rate of first
      trimester fetal demise.

      our aim: To evaluate the accuracy of ultrasound findings in comparison to serum CA125 and
      progesterone in predicting fetal demise in cases of first trimester threatened miscarriage.

      Will this pregnancy be continued after the first trimester or not?
we are comparing between the accuracy of vaginal ultra sound versus serum progesterone level
      and serum CA 125 level in predicting of fetal demise in cases of threatened miscarriage three
      vaginal ultrasounds will be done ) the first one will be done at six to eight weeks of
      pregnancy to the patients who fulfill the criteria in this us we will make sure that the
      cardiac pulsations are present and measure the following:

        1. the fetal heart rate,

        2. the crown rump length

        3. gestational sac diameter

        4. yolk sac diameter. b) The second ultra sound will be after two weeks from the first one
           to follow up the patient for pregnancy survival, take the same measures again and
           correlate them with the results of laboratory investigations to select the investigation
           which is most accurate in anticipating outcome in cases of threatened abortion.

      C) the third one will be at the end of first trimester (13 weeks) to ensure fetal viability.

      . embryonic bradycardia and absence of yolk sac or smaller yolk sac than expected for any
      given gestational age are prognostic factors of poor pregnancy outcome in the first 12 weeks
      of pregnancy women with small for age gestational sac are more prone to have miscarriage we
      will do laboratory investigation in the form of A) Serum progesterone: low maternal P levels
      have been useful in predicting spontaneous abortion in threatened pregnancies with a
      sensitivity of 80% (<10 ng /mL) so, this will be our cutoff value. B) Serum CA 125 :we will
      take a level of 51.5 as cut off value.this is the upper level of normal we will do them once
      when the patient presents to us.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Other
masking: None (Open Label)
measure: ultra sound
time frame: the 12th week of gestation
description: presence of fetal heart rate
arm group label: threatened miscarriage
arm group type: Other
description: ultrasound ,CA125,progesterone
intervention type: Diagnostic Test
intervention name: ultrasound
description: To evaluate the accuracy of ultrasound findings in comparison to serum CA125and progesterone in predicting fetal demise in cases of first trimester threatened miscarriage.
arm group label: threatened miscarriage
other name: progesterone
other name: CA125
criteria: 
gender: Female
minimum age: 20 Years
maximum age: 35 Years
healthy volunteers: No
last name: amany a mahmoud
role: Principal Investigator
affiliation: Ain Shams University
last name: mohamed k abdelwahab, master
phone: 01000849822
phone ext: 002
email: m.k.ali1987@gmail.com
facility: 
status: Recruiting
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Ain Shams University
investigator full name: amany abdel monem mahmoud
investigator title: Egypt Cairo
mesh term: Abortion, Spontaneous
mesh term: Abortion, Threatened
mesh term: Progesterone