xml: <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/NCT06011057</url>
    </required_header>
    <id_info>
      <org_study_id>Gyna._531</org_study_id>
      <nct_id>NCT06011057</nct_id>
    </id_info>
    <brief_title>Evaluation of Serum Levels of C Reactive Protein (CRP) and Its Correlation With Fetal Ultrasound Parameters in the Prediction of Threatened Miscarriage in the First Trimester</brief_title>
    <official_title>Evaluation of Serum Levels of C Reactive Protein (CRP) and Its Correlation With Fetal Ultrasound Parameters in the Prediction of Threatened Miscarriage in the First Trimester</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Al-Azhar University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Al-Azhar University</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The goal of this observational study is to evaluate and compare in pregnant women with&#xD;
        threatened miscarriage in the first trimester. The main questions it aims to answer are:&#xD;
  &#xD;
        What is the correlation between serum C reactive protein (CRP) levels and fetal ultrasound&#xD;
        parameters in predicting threatened miscarriage? How accurate are serum C reactive protein&#xD;
        (CRP) levels versus ultrasound in predicting pregnancy loss in threatened miscarriage?&#xD;
        Participants will have blood tests to measure C reactive protein (CRP) levels and fetal&#xD;
        ultrasound exams to assess parameters like crown-rump length.&#xD;
  &#xD;
        Researchers will compare serum C reactive protein (CRP) levels and fetal ultrasound findings&#xD;
        to see if either or both can accurately predict pregnancy loss in women with first trimester&#xD;
        threatened miscarriage.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This observational study will enroll 100 pregnant women, with 50 in the threatened&#xD;
        miscarriage group and 50 healthy controls, to compare serum C reactive protein (CRP) levels&#xD;
        and fetal ultrasound findings for predicting early pregnancy loss.&#xD;
  &#xD;
        Women presenting with first trimester bleeding and cramps concerning for threatened&#xD;
        miscarriage will undergo blood testing to measure C reactive protein (CRP) levels and fetal&#xD;
        ultrasound to assess parameters including crown-rump length, heartbeat, yolk sac size, and&#xD;
        embryonic motion.&#xD;
  &#xD;
        The control group will consist of 50 low-risk pregnant women without threatened miscarriage&#xD;
        matched for gestational age. Controls will undergo the same blood and ultrasound assessments.&#xD;
  &#xD;
        Researchers will compare serum C reactive protein (CRP) levels and ultrasound measurements&#xD;
        between the threatened miscarriage and control groups. They will analyze which parameters&#xD;
        differ significantly between groups and examine the predictive utility of C reactive protein&#xD;
        (CRP) levels versus ultrasound for determining pregnancy viability.&#xD;
  &#xD;
        Key outcomes will include correlation of C reactive protein (CRP) with ultrasound parameters,&#xD;
        and diagnostic accuracy of C reactive protein (CRP) levels versus ultrasound in predicting&#xD;
        pregnancy loss in threatened first trimester miscarriages.&#xD;
  &#xD;
        This study aims to help optimize early pregnancy loss prediction and counseling for women&#xD;
        with potential threatened miscarriage.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">July 1, 2022</start_date>
    <completion_date type="Anticipated">October 2023</completion_date>
    <primary_completion_date type="Anticipated">September 2023</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Case-Control</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Serum C reactive protein (CRP) levels in threatened miscarriage vs control groups</measure>
      <time_frame>At enrollment (6-14 weeks gestation)</time_frame>
      <description>Serum C-reactive protein (CRP) levels will be compared between the threatened miscarriage and control groups. CRP levels will be assessed from blood samples collected at the time of enrollment in the study (6-14 weeks gestation). The goal is to determine if CRP levels differ significantly between the threatened miscarriage and control groups and examine the correlation between C reactive protein (CRP) levels and threatened early pregnancy loss.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Ongoing pregnancy</measure>
      <time_frame>Ongoing pregnancy assessed at 24 weeks gestation</time_frame>
      <description>Ongoing pregnancy rates at 24 weeks gestation will be compared between the threatened miscarriage and control groups.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>miscarriage rates</measure>
      <time_frame>pregnancy loss before 20 weeks</time_frame>
      <description>Miscarriage rates, defined as pregnancy loss before 20 weeks, will also be compared between the two groups through completion of the study.</description>
    </secondary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Anticipated">100</enrollment>
    <condition>Threatened Miscarriage</condition>
    <arm_group>
      <arm_group_label>threatened miscarriage Group</arm_group_label>
      <description>This group will include 50 pregnant women presenting with vaginal bleeding and/or abdominal cramps concerning for possible miscarriage in the first trimester. Inclusion criteria will be gestational age between 6-14 weeks by last menstrual period and/or ultrasound dating, and clinical signs/symptoms suggestive of threatened miscarriage including:&#xD;
  Vaginal bleeding Abdominal cramps/pain Closed cervical os on exam Women with confirmed fetal demise on ultrasound will be excluded. Participants in this group will undergo blood testing to measure C reactive protein (CRP) level and fetal ultrasound to assess parameters like crown-rump length, heartbeat, yolk sac size, and embryonic motion. This group will provide data to assess C reactive protein (CRP) and ultrasound findings in women with threatened first trimester miscarriage.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control Group</arm_group_label>
      <description>The control group will include 50 low-risk pregnant women matched to the threatened miscarriage group based on gestational age. Inclusion criteria are normal pregnancy dating, no vaginal bleeding/cramping, normal prior ultrasounds, and no history of pregnancy complications. Controls will undergo the same CRP blood testing and fetal ultrasounds as the threatened miscarriage group. This will provide comparative normal pregnancy CRP and ultrasound data. Matching controls on demographics and gestation will allow analysis of differences in CRP and ultrasound parameters between groups to determine predictors of pregnancy viability.&#xD;
  Copy Retry</description>
    </arm_group>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>Serum C reactive protein (CRP) level</intervention_name>
      <description>An immunoturbidimetric method using a Modular P Analyzer will be used to carry out HSCRP assay, with a quantitation limit of 0.5 mg/L.</description>
      <arm_group_label>Control Group</arm_group_label>
      <arm_group_label>threatened miscarriage Group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>Ultrasound</intervention_name>
      <description>All examinations will be carried out by an experience operator with a transvaginal probe on high-resolution ultrasound machines. Pregnancies will be dated from the LMP. Other measurements will be obtained during the scan as the mean gestation sac diameter, volume of the gestation sac and the embryonic heart rate (FHR).</description>
      <arm_group_label>Control Group</arm_group_label>
      <arm_group_label>threatened miscarriage Group</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          The study population will consist of 100 pregnant women, including 50 with threatened&#xD;
          miscarriage and 50 healthy controls, recruited from obstetrics clinic at Al-Hussein&#xD;
          University Hospital&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  All pregnant women in the age group (20-35) between 7 and 13 weeks gestation in which&#xD;
               a singleton embryo with evident cardiac activity with sure last menstrual period (LMP)&#xD;
               constant with 1st trimester documented ultrasound&#xD;
  &#xD;
            -  The included subjects will be divided into two groups:-&#xD;
  &#xD;
                 1. Group 1 (control) will consist of 50 pregnant women with uneventful pregnancies&#xD;
                    without any problem.&#xD;
  &#xD;
                 2. Group 2 (patients) will consist of 50 pregnant women with threatened miscarriage,&#xD;
                    of them.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Multiple pregnancies.&#xD;
  &#xD;
            -  Women having received hormonal treatment or progesterone supplements.&#xD;
  &#xD;
            -  Pregnancies with a difference of more than 7 days between last menstrual period (LMP)&#xD;
               and crown- rump length.&#xD;
  &#xD;
            -  History of general medical disease e.g. diabetes, thyroid disease or antiphospholipid&#xD;
               syndrome, Presence of local (gynecological) disease e.g. fibroid or adnexal masses&#xD;
               verified by normal appearance of the uterus and ovaries by ultrasound.&#xD;
  &#xD;
            -  Presence of uterine malformations e.g. hypoplastic uterus or septate uterus diagnosed&#xD;
               by history of recurrent miscarriage, hysterosalpingography or 3D ultrasound, Intake of&#xD;
               natural or synthetic progesterone.&#xD;
  &#xD;
            -  Obesity.&#xD;
  &#xD;
            -  Ectopic pregnancy&#xD;
  &#xD;
            -  Vesicular mole&#xD;
  &#xD;
            -  Fetal demise by Ultrasound&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <gender_based>Yes</gender_based>
      <gender_description>This study will only enroll pregnant women whose gender identity and biological sex assigned at birth are both female. Individuals who identify as any gender other than female will not be eligible, as the study is specifically assessing threatened miscarriage and pregnancy outcomes in women based on their biological sex. Eligible participants must self-identify and be biologically classified as female to align with the research questions on CRP levels, ultrasound findings, and pregnancy loss risk in women with threatened first trimester miscarriage.</gender_description>
      <minimum_age>20 Years</minimum_age>
      <maximum_age>35 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Muhamed A Abdelmoaty, M.D.</last_name>
      <role>Principal Investigator</role>
      <affiliation>Al-Azhar University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Muhamed A Abdelmoaty, M.D.</last_name>
      <phone>00201017313413</phone>
      <email>MuhamedAhmed.216@azhar.edu.eg</email>
    </overall_contact>
    <location>
      <facility>
        <name>Al-Hussein University Hospital</name>
        <address>
          <city>Cairo</city>
          <zip>11633</zip>
          <country>Egypt</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Muhamed A Alhagrasy, M.D.</last_name>
        <phone>00201017313413</phone>
        <email>MuhamedAhmed.216@azhar.edu.eg</email>
      </contact>
    </location>
    <location_countries>
      <country>Egypt</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 21, 2023</study_first_submitted>
    <study_first_submitted_qc>August 23, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 25, 2023</study_first_posted>
    <last_update_submitted>August 23, 2023</last_update_submitted>
    <last_update_submitted_qc>August 23, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 25, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Al-Azhar University</investigator_affiliation>
      <investigator_full_name>Muhamed Ahmed Abdelmoaty Muhamed Alhagrasy</investigator_full_name>
      <investigator_title>lecturer and consultant at Obstetrics and Gynecology Department.</investigator_title>
    </responsible_party>
    <keyword>threatened miscarriage</keyword>
    <keyword>ultrasound parameters</keyword>
    <keyword>C reactive protein</keyword>
    <keyword>first trimester</keyword>
    <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>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>The sample size is small, so there is a risk of breaching participant privacy and identifiability even with de-identified data sets. We want to prioritize protecting patient confidentiality.&#xD;
  Participants were not consented for broad data sharing, only for use of their data specifically for this study. Additional consent processes would be needed to enable sharing.&#xD;
  There are logistical barriers around data de-identification, establishing a repository, and creating data use agreements which are beyond the scope of this study.&#xD;
  The research questions can be adequately answered through analysis of aggregated data and publication of results. Sharing individual-level data is not necessary to achieve the specific aims.&#xD;
  The sensitive nature of pregnancy loss data further underscores the need for confidentiality safeguards. Participants may not feel comfortable with their pregnancy information being shared widely.</ipd_description>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06011057
  org study id: Gyna._531
  nct id: NCT06011057
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this observational study is to evaluate and compare in pregnant women with
        threatened miscarriage in the first trimester. The main questions it aims to answer are:
  
        What is the correlation between serum C reactive protein (CRP) levels and fetal ultrasound
        parameters in predicting threatened miscarriage? How accurate are serum C reactive protein
        (CRP) levels versus ultrasound in predicting pregnancy loss in threatened miscarriage?
        Participants will have blood tests to measure C reactive protein (CRP) levels and fetal
        ultrasound exams to assess parameters like crown-rump length.
  
        Researchers will compare serum C reactive protein (CRP) levels and fetal ultrasound findings
        to see if either or both can accurately predict pregnancy loss in women with first trimester
        threatened miscarriage.
  This observational study will enroll 100 pregnant women, with 50 in the threatened
        miscarriage group and 50 healthy controls, to compare serum C reactive protein (CRP) levels
        and fetal ultrasound findings for predicting early pregnancy loss.
  
        Women presenting with first trimester bleeding and cramps concerning for threatened
        miscarriage will undergo blood testing to measure C reactive protein (CRP) levels and fetal
        ultrasound to assess parameters including crown-rump length, heartbeat, yolk sac size, and
        embryonic motion.
  
        The control group will consist of 50 low-risk pregnant women without threatened miscarriage
        matched for gestational age. Controls will undergo the same blood and ultrasound assessments.
  
        Researchers will compare serum C reactive protein (CRP) levels and ultrasound measurements
        between the threatened miscarriage and control groups. They will analyze which parameters
        differ significantly between groups and examine the predictive utility of C reactive protein
        (CRP) levels versus ultrasound for determining pregnancy viability.
  
        Key outcomes will include correlation of C reactive protein (CRP) with ultrasound parameters,
        and diagnostic accuracy of C reactive protein (CRP) levels versus ultrasound in predicting
        pregnancy loss in threatened first trimester miscarriages.
  
        This study aims to help optimize early pregnancy loss prediction and counseling for women
        with potential threatened miscarriage.
  observational model: Case-Control
  time perspective: Prospective
  measure: Serum C reactive protein (CRP) levels in threatened miscarriage vs control groups
  time frame: At enrollment (6-14 weeks gestation)
  description: Serum C-reactive protein (CRP) levels will be compared between the threatened miscarriage and control groups. CRP levels will be assessed from blood samples collected at the time of enrollment in the study (6-14 weeks gestation). The goal is to determine if CRP levels differ significantly between the threatened miscarriage and control groups and examine the correlation between C reactive protein (CRP) levels and threatened early pregnancy loss.
  measure: Ongoing pregnancy
  time frame: Ongoing pregnancy assessed at 24 weeks gestation
  description: Ongoing pregnancy rates at 24 weeks gestation will be compared between the threatened miscarriage and control groups.
  measure: miscarriage rates
  time frame: pregnancy loss before 20 weeks
  description: Miscarriage rates, defined as pregnancy loss before 20 weeks, will also be compared between the two groups through completion of the study.
  arm group label: threatened miscarriage Group
  description: This group will include 50 pregnant women presenting with vaginal bleeding and/or abdominal cramps concerning for possible miscarriage in the first trimester. Inclusion criteria will be gestational age between 6-14 weeks by last menstrual period and/or ultrasound dating, and clinical signs/symptoms suggestive of threatened miscarriage including:
  Vaginal bleeding Abdominal cramps/pain Closed cervical os on exam Women with confirmed fetal demise on ultrasound will be excluded. Participants in this group will undergo blood testing to measure C reactive protein (CRP) level and fetal ultrasound to assess parameters like crown-rump length, heartbeat, yolk sac size, and embryonic motion. This group will provide data to assess C reactive protein (CRP) and ultrasound findings in women with threatened first trimester miscarriage.
  arm group label: Control Group
  description: The control group will include 50 low-risk pregnant women matched to the threatened miscarriage group based on gestational age. Inclusion criteria are normal pregnancy dating, no vaginal bleeding/cramping, normal prior ultrasounds, and no history of pregnancy complications. Controls will undergo the same CRP blood testing and fetal ultrasounds as the threatened miscarriage group. This will provide comparative normal pregnancy CRP and ultrasound data. Matching controls on demographics and gestation will allow analysis of differences in CRP and ultrasound parameters between groups to determine predictors of pregnancy viability.
  Copy Retry
  intervention type: Diagnostic Test
  intervention name: Serum C reactive protein (CRP) level
  description: An immunoturbidimetric method using a Modular P Analyzer will be used to carry out HSCRP assay, with a quantitation limit of 0.5 mg/L.
  arm group label: Control Group
  arm group label: threatened miscarriage Group
  intervention type: Diagnostic Test
  intervention name: Ultrasound
  description: All examinations will be carried out by an experience operator with a transvaginal probe on high-resolution ultrasound machines. Pregnancies will be dated from the LMP. Other measurements will be obtained during the scan as the mean gestation sac diameter, volume of the gestation sac and the embryonic heart rate (FHR).
  arm group label: Control Group
  arm group label: threatened miscarriage Group
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: Female
  gender based: Yes
  gender description: This study will only enroll pregnant women whose gender identity and biological sex assigned at birth are both female. Individuals who identify as any gender other than female will not be eligible, as the study is specifically assessing threatened miscarriage and pregnancy outcomes in women based on their biological sex. Eligible participants must self-identify and be biologically classified as female to align with the research questions on CRP levels, ultrasound findings, and pregnancy loss risk in women with threatened first trimester miscarriage.
  minimum age: 20 Years
  maximum age: 35 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Muhamed A Abdelmoaty, M.D.
  role: Principal Investigator
  affiliation: Al-Azhar University
  last name: Muhamed A Abdelmoaty, M.D.
  phone: 00201017313413
  email: MuhamedAhmed.216@azhar.edu.eg
  facility: 
  status: Recruiting
  contact: 
  country: Egypt
  responsible party type: Principal Investigator
  investigator affiliation: Al-Azhar University
  investigator full name: Muhamed Ahmed Abdelmoaty Muhamed Alhagrasy
  investigator title: lecturer and consultant at Obstetrics and Gynecology Department.
  mesh term: Abortion, Spontaneous
  mesh term: Abortion, Threatened
  sharing ipd: No
  ipd description: The sample size is small, so there is a risk of breaching participant privacy and identifiability even with de-identified data sets. We want to prioritize protecting patient confidentiality.
  Participants were not consented for broad data sharing, only for use of their data specifically for this study. Additional consent processes would be needed to enable sharing.
  There are logistical barriers around data de-identification, establishing a repository, and creating data use agreements which are beyond the scope of this study.
  The research questions can be adequately answered through analysis of aggregated data and publication of results. Sharing individual-level data is not necessary to achieve the specific aims.
  The sensitive nature of pregnancy loss data further underscores the need for confidentiality safeguards. Participants may not feel comfortable with their pregnancy information being shared widely.