<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/NCT04400149</url>
  </required_header>
  <id_info>
    <org_study_id>amniotic fluid progesteron</org_study_id>
    <nct_id>NCT04400149</nct_id>
  </id_info>
  <brief_title>Progesterone Levels and Pregnancy Results</brief_title>
  <official_title>The Effect of Maternal Serum and Amniotic Fluid Progesterone Levels on Pregnancy Results</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ufuk University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ufuk University</source>
  <oversight_info>
    <has_dmc>No</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 aim of this study is to evaluate the amniotic fluid and serum progesterone level and&#xD;
      pregnancy outcome&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Studies have investigated the relationship between maternal serum progesterone level and low&#xD;
      birth weight baby birth, hypertensive disorders of pregnancy, and early pregnancy bleeding.&#xD;
      In some cases, patients are supported by oral or vaginal progesterone treatments during&#xD;
      pregnancy. We also measure the relationship between maternal serum progesterone by measuring&#xD;
      the level of amnion progesterone; We aimed to analyze the effects on pregnancy outcomes by&#xD;
      observing preterm birth, premature rupture of membranes, low birth weight, baby gender,&#xD;
      maternal problems that may occur during pregnancy, fetal problems.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Not yet recruiting</overall_status>
  <start_date type="Anticipated">December 1, 2021</start_date>
  <completion_date type="Anticipated">November 20, 2022</completion_date>
  <primary_completion_date type="Anticipated">June 20, 2022</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>pregnancy outcome</measure>
    <time_frame>starting from 16 weeks, ending at the delivery of the baby</time_frame>
    <description>premature membran rupture Web sonuçları&#xD;
Premature Rupture of Membranes</description>
  </primary_outcome>
  <primary_outcome>
    <measure>pregnancy outcome</measure>
    <time_frame>starting from 16 weeks, ending at the delivery of the baby</time_frame>
    <description>pregnancy loss</description>
  </primary_outcome>
  <primary_outcome>
    <measure>pregnancy outcome</measure>
    <time_frame>starting from 16 weeks, ending at the delivery of the baby</time_frame>
    <description>preeclampsia</description>
  </primary_outcome>
  <primary_outcome>
    <measure>pregnancy outcome</measure>
    <time_frame>starting from 16 weeks, ending at the delivery of the baby</time_frame>
    <description>gestational diabetes</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>fetal outcomes</measure>
    <time_frame>starting from 16 weeks, ending at the delivery of the baby</time_frame>
    <description>low birth weight</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>fetal outcomes</measure>
    <time_frame>starting from 16 weeks, ending at the delivery of the baby</time_frame>
    <description>preterm labor</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>fetal outcomes</measure>
    <time_frame>starting from 16 weeks, ending at the delivery of the baby</time_frame>
    <description>fetal gender</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Pregnancy Complications</condition>
  <condition>Pregnancy Preterm</condition>
  <condition>Pregnancy Loss</condition>
  <arm_group>
    <arm_group_label>1</arm_group_label>
    <description>amniotic fluid progesterone (this group will be evaluated by the amniotic fluid which was received via amniocentesis). This group consisted of pregnant women who had high risk in the antenal test and give consent to perform amniocentesis. Notwithstanding, amniocentesis detects chromosome abnormalities, neural tube defects, and genetic disorders for the fetuses. İn a routine amniocentesis, 1-2 ml amniotic fluid which was taken in the first place was discarded in order to prevent maternal contamination. Then 15-20 ml amniotic fluid was taken from all of the patients to diagnose genetic disorders of the fetuses. İn this study we evaluate the amniotic fluid progesterone in this 1-2 ml amniotic fluid which was discarded and throw away. Therefore, we are not performing an extra invasive procedure for pregnant women</description>
  </arm_group>
  <arm_group>
    <arm_group_label>2</arm_group_label>
    <description>serum progesterone (this group consisted of the pregnant women who have amniocentesis procedure and blood samples were taken in the same procedure )</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>amniocentesis</intervention_name>
    <description>amniocentesis will be performed to the pregnant women at 16-20 weeks who had a high-risk antenatal test. Furthermore, these women also give a blood sample (at 16-20 weeks) to compare the amniotic fluid and serum progesterone levels in association with pregnancy outcomes. We perform amniocentesis to evaluate genetic disorders in pregnant women who had his risk in the antenal test.</description>
    <arm_group_label>1</arm_group_label>
    <arm_group_label>2</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The study population consists of 18-45 years old pregnant women who had a high risk in the&#xD;
        antenatal screening test and give consent to perform amniocentesis.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Singleton pregnancy&#xD;
&#xD;
          -  Women who did not receive progesterone treatment during pregnancy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Women who receive progesterone treatment during pregnancy&#xD;
&#xD;
          -  multiple pregnancies&#xD;
&#xD;
          -  Diagnosed hypertension, diabetes mellitus, kidney disease, heart disease, liver&#xD;
             disease&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>tufan arslanca, M.D.</last_name>
    <phone>+905324580546</phone>
    <email>drtufanarslanca@hotmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>banu arslanca, M.D.</last_name>
    <phone>+90 532 253 80 13</phone>
    <email>dr.banubozkurt@hotmail.com</email>
  </overall_contact_backup>
  <link>
    <url>http://www.ncbi.nlm.nih.gov/pubmed/?term=Progesterone+levels+in+amniotic+fluid+and+plasma+from+women.+I.+Levels+during+normal+pregnancy</url>
    <description>Related Info</description>
  </link>
  <link>
    <url>http://www.ncbi.nlm.nih.gov/pubmed/?term=The+concentration+of+progesterone%2C+20%5Cg%3Da%5C-dihydroprogesterone%2C+testosterone%2C+oestrone+and+oestradiol-17%5Cg%3Db%5Cin+serum%2C+amniotic+fluid+and+placental+tissue+of+pregnant+rabbits</url>
    <description>Related Info</description>
  </link>
  <results_reference>
    <citation>Johansson ED, Jonasson LE. Progesterone levels in amniotic fluid and plasma from women. I. Levels during normal pregnancy. Acta Obstet Gynecol Scand. 1971;50(4):339-43. doi: 10.3109/00016347109157335. No abstract available.</citation>
    <PMID>5157500</PMID>
  </results_reference>
  <results_reference>
    <citation>Lau IF, Saksena SK, Salmonsen R. The concentration of progesterone, 20 alpha-dihydroprogesterone, testosterone, oestrone and oestradiol-17 beta in serum, amniotic fluid and placental tissue of pregnant rabbits. Acta Endocrinol (Copenh). 1982 Apr;99(4):605-11. doi: 10.1530/acta.0.0990605.</citation>
    <PMID>7072456</PMID>
  </results_reference>
  <verification_date>October 2021</verification_date>
  <study_first_submitted>May 19, 2020</study_first_submitted>
  <study_first_submitted_qc>May 19, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 22, 2020</study_first_posted>
  <last_update_submitted>October 31, 2021</last_update_submitted>
  <last_update_submitted_qc>October 31, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">November 2, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ufuk University</investigator_affiliation>
    <investigator_full_name>Tufan Arslanca</investigator_full_name>
    <investigator_title>M.D.</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pregnancy Complications</mesh_term>
  </condition_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/NCT04400149
org study id: amniotic fluid progesteron
nct id: NCT04400149
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim of this study is to evaluate the amniotic fluid and serum progesterone level and
      pregnancy outcome
Studies have investigated the relationship between maternal serum progesterone level and low
      birth weight baby birth, hypertensive disorders of pregnancy, and early pregnancy bleeding.
      In some cases, patients are supported by oral or vaginal progesterone treatments during
      pregnancy. We also measure the relationship between maternal serum progesterone by measuring
      the level of amnion progesterone; We aimed to analyze the effects on pregnancy outcomes by
      observing preterm birth, premature rupture of membranes, low birth weight, baby gender,
      maternal problems that may occur during pregnancy, fetal problems.
observational model: Cohort
time perspective: Prospective
measure: pregnancy outcome
time frame: starting from 16 weeks, ending at the delivery of the baby
description: premature membran rupture Web sonuçları
Premature Rupture of Membranes
measure: pregnancy outcome
time frame: starting from 16 weeks, ending at the delivery of the baby
description: pregnancy loss
measure: pregnancy outcome
time frame: starting from 16 weeks, ending at the delivery of the baby
description: preeclampsia
measure: pregnancy outcome
time frame: starting from 16 weeks, ending at the delivery of the baby
description: gestational diabetes
measure: fetal outcomes
time frame: starting from 16 weeks, ending at the delivery of the baby
description: low birth weight
measure: fetal outcomes
time frame: starting from 16 weeks, ending at the delivery of the baby
description: preterm labor
measure: fetal outcomes
time frame: starting from 16 weeks, ending at the delivery of the baby
description: fetal gender
arm group label: 1
description: amniotic fluid progesterone (this group will be evaluated by the amniotic fluid which was received via amniocentesis). This group consisted of pregnant women who had high risk in the antenal test and give consent to perform amniocentesis. Notwithstanding, amniocentesis detects chromosome abnormalities, neural tube defects, and genetic disorders for the fetuses. İn a routine amniocentesis, 1-2 ml amniotic fluid which was taken in the first place was discarded in order to prevent maternal contamination. Then 15-20 ml amniotic fluid was taken from all of the patients to diagnose genetic disorders of the fetuses. İn this study we evaluate the amniotic fluid progesterone in this 1-2 ml amniotic fluid which was discarded and throw away. Therefore, we are not performing an extra invasive procedure for pregnant women
arm group label: 2
description: serum progesterone (this group consisted of the pregnant women who have amniocentesis procedure and blood samples were taken in the same procedure )
intervention type: Diagnostic Test
intervention name: amniocentesis
description: amniocentesis will be performed to the pregnant women at 16-20 weeks who had a high-risk antenatal test. Furthermore, these women also give a blood sample (at 16-20 weeks) to compare the amniotic fluid and serum progesterone levels in association with pregnancy outcomes. We perform amniocentesis to evaluate genetic disorders in pregnant women who had his risk in the antenal test.
arm group label: 1
arm group label: 2
study pop: 
sampling method: Probability Sample
criteria: 
gender: Female
gender based: Yes
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
last name: tufan arslanca, M.D.
phone: +905324580546
email: drtufanarslanca@hotmail.com
last name: banu arslanca, M.D.
phone: +90 532 253 80 13
email: dr.banubozkurt@hotmail.com
url: http://www.ncbi.nlm.nih.gov/pubmed/?term=Progesterone+levels+in+amniotic+fluid+and+plasma+from+women.+I.+Levels+during+normal+pregnancy
description: Related Info
url: http://www.ncbi.nlm.nih.gov/pubmed/?term=The+concentration+of+progesterone%2C+20%5Cg%3Da%5C-dihydroprogesterone%2C+testosterone%2C+oestrone+and+oestradiol-17%5Cg%3Db%5Cin+serum%2C+amniotic+fluid+and+placental+tissue+of+pregnant+rabbits
description: Related Info
citation: Johansson ED, Jonasson LE. Progesterone levels in amniotic fluid and plasma from women. I. Levels during normal pregnancy. Acta Obstet Gynecol Scand. 1971;50(4):339-43. doi: 10.3109/00016347109157335. No abstract available.
PMID: 5157500
citation: Lau IF, Saksena SK, Salmonsen R. The concentration of progesterone, 20 alpha-dihydroprogesterone, testosterone, oestrone and oestradiol-17 beta in serum, amniotic fluid and placental tissue of pregnant rabbits. Acta Endocrinol (Copenh). 1982 Apr;99(4):605-11. doi: 10.1530/acta.0.0990605.
PMID: 7072456
responsible party type: Principal Investigator
investigator affiliation: Ufuk University
investigator full name: Tufan Arslanca
investigator title: M.D.
mesh term: Pregnancy Complications
sharing ipd: No