<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/NCT02979834</url>
  </required_header>
  <id_info>
    <org_study_id>E52332816/53</org_study_id>
    <nct_id>NCT02979834</nct_id>
  </id_info>
  <brief_title>When Will I Feel The First Movements of My Baby?</brief_title>
  <acronym>FFM</acronym>
  <official_title>A Frequently Asked Question: When Will I Feel The First Movements of My Baby?</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kayseri Education and Research Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Kayseri Education and Research Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study aims to investigate average gestational week in which mothers feel the&#xD;
      babies'movements for the first time and maternal-fetal factors affecting this time.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Most of the obstetricians face the question; &quot;When Will I Feel The First Movements of My&#xD;
      Baby?&quot;, in daily practice. It becomes a challenge for the obstetrician to answer this&#xD;
      question. Because, there is not a sufficient data in the current literature on this issue. A&#xD;
      broad range of weeks for fetal quickening are reported as 16th to 20th weeks, in round&#xD;
      figures. So, when a woman in the 21st gestational week , asks this question to the&#xD;
      obstetrician and informed according to aforementioned literature knowledge, the woman will&#xD;
      ask another question immediately after: &quot;What is the problem with my baby?&quot;. But, the&#xD;
      obstetrician will not be able to give an assuring answer because of the lack of knowledge in&#xD;
      the current literature.Thus, to cope with such a clinical situation, the investigators&#xD;
      decided to investigate the average week in which pregnant women in a low risk population,&#xD;
      felt the babies' movements for the first time and to find out the affects of probable factors&#xD;
      which may act on this time.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>June 2016</start_date>
  <completion_date type="Actual">October 2016</completion_date>
  <primary_completion_date type="Actual">October 2016</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>placental settlement via ultrasound</measure>
    <time_frame>5 minutes</time_frame>
    <description>Relationship between placental location obtained via sonography and fetal movement perception</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>maternal body mass index measurement</measure>
    <time_frame>3 minutes</time_frame>
    <description>Relationship between Maternal Body Mass Index calculated by dividing body weight to height and fetal movement perception</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>maternal age</measure>
    <time_frame>1 minute</time_frame>
    <description>Relationship between Maternal age according to questionnaire and fetal movement perception</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>parity</measure>
    <time_frame>1 minute</time_frame>
    <description>Relationship between Maternal parity according to questionnaire and fetal movement perception</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>educational status</measure>
    <time_frame>1 minute</time_frame>
    <description>Relationship between maternal education status according to questionnaire and fetal movement perception</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>smoking</measure>
    <time_frame>1 minute</time_frame>
    <description>Relationship between Maternal smoking according to questionnaire and fetal movement perception</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>tea and coffee consumption</measure>
    <time_frame>1 minute</time_frame>
    <description>Relationship between maternal tea and coffee conception according to questionnaire and fetal movement perception</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>fetal gender</measure>
    <time_frame>5 minutes</time_frame>
    <description>Relationship between fetal gender obtained via sonography and fetal movement perception</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>regular pregnancy follow ups</measure>
    <time_frame>1 minute</time_frame>
    <description>Relationship between regular pregnancy follow ups recorded on patient record system and fetal movement perception</description>
  </secondary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Actual">423</enrollment>
  <condition>Early Pregnancy</condition>
  <arm_group>
    <arm_group_label>Early perception group</arm_group_label>
    <description>The group with early perception of fetal movement (&lt;25th percentile)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Average perception group</arm_group_label>
    <description>The group with average perception of fetal movement (&gt;25th and &lt;75th percentile)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Late perception group</arm_group_label>
    <description>The group which late perception of fetal movement (&gt;75 percentile)</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Three groups were formed according to the gestational week in which fetal movements felt by&#xD;
        mother for the first time. 25th percentile, 50thand 75th percentile values were determined&#xD;
        .Participants who felt the babies' movements at or before 25th percentile value constituted&#xD;
        Group1 or early perception group, participants who felt the babies' movements between 25th&#xD;
        and 75th percentile value constituted Group 2 or average perception group and the&#xD;
        participants who felt the babies'movements at or beyond 75th value constituted Group 3 or&#xD;
        late perception group. Subsequently, these three groups were compared regarding maternal&#xD;
        age, gestational week of inclusion in the study, obstetric features, maternal body mass&#xD;
        index values, caffeine consumption, smoking status, maternal education status, placental&#xD;
        localization and fetal gender.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  The study population included spontaneous, singleton pregnancies at first and&#xD;
             second-trimester of their pregnancy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Multiple pregnancies, evidence of fetal or maternal infection, hypertensive disorders&#xD;
             of gestation, gestational and pregestational diabetes mellitus, maternal drug use,&#xD;
             evidence of fetal congenital abnormalities and amniotic fluid abnormalities were&#xD;
             stated as the exclusion criteria for the study group.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Hatice Akkaya, M.D</last_name>
    <role>Principal Investigator</role>
    <affiliation>Kayseri Education and Research Hospital</affiliation>
  </overall_official>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>November 26, 2016</study_first_submitted>
  <study_first_submitted_qc>November 29, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 2, 2016</study_first_posted>
  <last_update_submitted>November 29, 2016</last_update_submitted>
  <last_update_submitted_qc>November 29, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 2, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Kayseri Education and Research Hospital</investigator_affiliation>
    <investigator_full_name>Hatice Akkaya</investigator_full_name>
    <investigator_title>Principle investigator</investigator_title>
  </responsible_party>
  <keyword>fetal movement</keyword>
  <keyword>placenta site</keyword>
  <keyword>body mass index</keyword>
  <keyword>maternal education</keyword>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>The data belonging to participant will be available to any researcher or editorial review board if needed.</ipd_description>
  </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/NCT02979834
org study id: E52332816/53
nct id: NCT02979834
lead sponsor: 
has dmc: No
This study aims to investigate average gestational week in which mothers feel the
      babies'movements for the first time and maternal-fetal factors affecting this time.
Most of the obstetricians face the question; "When Will I Feel The First Movements of My
      Baby?", in daily practice. It becomes a challenge for the obstetrician to answer this
      question. Because, there is not a sufficient data in the current literature on this issue. A
      broad range of weeks for fetal quickening are reported as 16th to 20th weeks, in round
      figures. So, when a woman in the 21st gestational week , asks this question to the
      obstetrician and informed according to aforementioned literature knowledge, the woman will
      ask another question immediately after: "What is the problem with my baby?". But, the
      obstetrician will not be able to give an assuring answer because of the lack of knowledge in
      the current literature.Thus, to cope with such a clinical situation, the investigators
      decided to investigate the average week in which pregnant women in a low risk population,
      felt the babies' movements for the first time and to find out the affects of probable factors
      which may act on this time.
observational model: Cohort
time perspective: Prospective
measure: placental settlement via ultrasound
time frame: 5 minutes
description: Relationship between placental location obtained via sonography and fetal movement perception
measure: maternal body mass index measurement
time frame: 3 minutes
description: Relationship between Maternal Body Mass Index calculated by dividing body weight to height and fetal movement perception
measure: maternal age
time frame: 1 minute
description: Relationship between Maternal age according to questionnaire and fetal movement perception
measure: parity
time frame: 1 minute
description: Relationship between Maternal parity according to questionnaire and fetal movement perception
measure: educational status
time frame: 1 minute
description: Relationship between maternal education status according to questionnaire and fetal movement perception
measure: smoking
time frame: 1 minute
description: Relationship between Maternal smoking according to questionnaire and fetal movement perception
measure: tea and coffee consumption
time frame: 1 minute
description: Relationship between maternal tea and coffee conception according to questionnaire and fetal movement perception
measure: fetal gender
time frame: 5 minutes
description: Relationship between fetal gender obtained via sonography and fetal movement perception
measure: regular pregnancy follow ups
time frame: 1 minute
description: Relationship between regular pregnancy follow ups recorded on patient record system and fetal movement perception
arm group label: Early perception group
description: The group with early perception of fetal movement (<25th percentile)
arm group label: Average perception group
description: The group with average perception of fetal movement (>25th and <75th percentile)
arm group label: Late perception group
description: The group which late perception of fetal movement (>75 percentile)
study pop: 
sampling method: Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Hatice Akkaya, M.D
role: Principal Investigator
affiliation: Kayseri Education and Research Hospital
responsible party type: Principal Investigator
investigator affiliation: Kayseri Education and Research Hospital
investigator full name: Hatice Akkaya
investigator title: Principle investigator
sharing ipd: Yes
ipd description: The data belonging to participant will be available to any researcher or editorial review board if needed.