<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/NCT03246711</url>
  </required_header>
  <id_info>
    <org_study_id>AAMABDELKADER 2</org_study_id>
    <nct_id>NCT03246711</nct_id>
  </id_info>
  <brief_title>Can Fasting Ramadan in the Third Trimester in Pregnancy Affects the Fetal Growth.</brief_title>
  <official_title>The Effect of 3rd Trimester Ramdan Fasting on Obestetric Outcome</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ain Shams Maternity Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ain Shams Maternity Hospital</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>
      Prospective comparative cohort study including 159 pregnant women at the third trimester&#xD;
      recruited from the antenatal clinic at EL-Demerdash outpatient clinic, and followed up during&#xD;
      the holy month of Ramadan (from 18th June To 16th July 2015).&#xD;
&#xD;
      The patients recorded their pattern of fasting during Ramadan then grouped into three groups&#xD;
      A, B, C regarding fasting state A- Non fasting group B- Partially fasting group C- Totally&#xD;
      fasting group&#xD;
&#xD;
      .&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Many pregnant muslims women fast during Ramadan Since fasting during Ramadan is one of the&#xD;
      five pillars of Islam and is a central part of Muslim culture, many women may fear a loss of&#xD;
      connection with their communities or would feel guilty if they did not observe Ramadan. Each&#xD;
      year, about 400 million out of 1 billion Muslims do this duty. Such tasks like eating,&#xD;
      drinking, and smoking are forbidden from sunrise until sunset. Fasting during pregnancy has&#xD;
      been always considered as a debatable condition.&#xD;
&#xD;
      Many women ask their obstetricians if fasting is safe for their baby or not? There have been&#xD;
      many studies on metabolic changes and different aspects of human health during and after&#xD;
      Ramadan .but there have been few studies on the effect of fasting on pregnancy outcome and&#xD;
      there are also some controversies in the findings of different studies.&#xD;
&#xD;
      All mothers within the age range of 20 - 35 years and in the 3rd trimester pregnancy&#xD;
      (starting from 28 weeks) which is going to be calculated according to the date of the last&#xD;
      menstrual period &amp; confirmed ultrasonically, normal healthy women with average body mass&#xD;
      index (BMI) and Women included have no medical disorder.&#xD;
&#xD;
      Women who fulfilled the eligibility criteria were subjected an ultrasound fetal biometry&#xD;
      every 2 weeks till delivery and assess fetal weight after delivery.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 18, 2015</start_date>
  <completion_date type="Actual">July 1, 2016</completion_date>
  <primary_completion_date type="Actual">July 17, 2015</primary_completion_date>
  <study_type>Observational [Patient Registry]</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>
  <target_duration>3 Months</target_duration>
  <primary_outcome>
    <measure>Fetal growth</measure>
    <time_frame>through study completion ( from 28 weeks pregnancy till delivery)</time_frame>
    <description>assessment of the fetal growth biometry ( estimated fetal weight) every two weeks,</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>neonatal weight</measure>
    <time_frame>at the time of delivery of each participant</time_frame>
    <description>measured in grams after delivery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>mode of delivery</measure>
    <time_frame>at the time of delivery of each participant</time_frame>
    <description>percentages of emergency CS due to presumed fetal compromise</description>
  </secondary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Actual">159</enrollment>
  <condition>Fasting</condition>
  <condition>Fetal Growth Retardation, Antenatal (Disorder)</condition>
  <arm_group>
    <arm_group_label>Totally fasting</arm_group_label>
    <description>Fasting each day from sunrise to sunset the whole month</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Partially fasting</arm_group_label>
    <description>means fasting from sunrise to sunset part of the month</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Non fasting</arm_group_label>
    <description>women who did not fast at all</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Fasting</intervention_name>
    <description>Totally or partially fasting the holy month of ramadan for muslims</description>
    <arm_group_label>Partially fasting</arm_group_label>
    <arm_group_label>Totally fasting</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Prospective comparative cohort study including 159 pregnant women at the third trimester&#xD;
        recruited from the antenatal clinic at EL-Demerdash outpatient clinic, and followed up&#xD;
        during the holy month of Ramadan (from 18th June To 16th July 2015).&#xD;
&#xD;
        The patients recorded their pattern of fasting during Ramadan then grouped into three&#xD;
        groups A, B, C regarding fasting state A- Non fasting group B- Partially fasting group C-&#xD;
        Totally fasting group&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age from 20 - 35 years.&#xD;
&#xD;
          -  Third trimester pregnancy (starting from 28 weeks) which is going to be calculated&#xD;
             according to the date of the last menstrual period &amp; confirmed by ultrasonography.&#xD;
&#xD;
          -  Normal healthy women with average body mass index (BMI). Normal range (18.5 to 25).&#xD;
&#xD;
          -  Women included have no medical disorder.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of systemic disorder.&#xD;
&#xD;
          -  Smoking narcotics or alcohol use.&#xD;
&#xD;
          -  Have previous history of fetal loss.&#xD;
&#xD;
          -  Multiple pregnancies.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>35 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>July 22, 2017</study_first_submitted>
  <study_first_submitted_qc>August 9, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 11, 2017</study_first_posted>
  <last_update_submitted>August 9, 2017</last_update_submitted>
  <last_update_submitted_qc>August 9, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 11, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ain Shams Maternity Hospital</investigator_affiliation>
    <investigator_full_name>AYMAN ABDELKADER MOHAMED ABDELKADER</investigator_full_name>
    <investigator_title>doctor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fetal Growth Retardation</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>no confidential data will be shared</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_time_frame>december 2019</ipd_time_frame>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>January 1, 2015</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/11/NCT03246711/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>October 1, 2015</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/11/NCT03246711/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT03246711
org study id: AAMABDELKADER 2
nct id: NCT03246711
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Prospective comparative cohort study including 159 pregnant women at the third trimester
      recruited from the antenatal clinic at EL-Demerdash outpatient clinic, and followed up during
      the holy month of Ramadan (from 18th June To 16th July 2015).

      The patients recorded their pattern of fasting during Ramadan then grouped into three groups
      A, B, C regarding fasting state A- Non fasting group B- Partially fasting group C- Totally
      fasting group

      .
Many pregnant muslims women fast during Ramadan Since fasting during Ramadan is one of the
      five pillars of Islam and is a central part of Muslim culture, many women may fear a loss of
      connection with their communities or would feel guilty if they did not observe Ramadan. Each
      year, about 400 million out of 1 billion Muslims do this duty. Such tasks like eating,
      drinking, and smoking are forbidden from sunrise until sunset. Fasting during pregnancy has
      been always considered as a debatable condition.

      Many women ask their obstetricians if fasting is safe for their baby or not? There have been
      many studies on metabolic changes and different aspects of human health during and after
      Ramadan .but there have been few studies on the effect of fasting on pregnancy outcome and
      there are also some controversies in the findings of different studies.

      All mothers within the age range of 20 - 35 years and in the 3rd trimester pregnancy
      (starting from 28 weeks) which is going to be calculated according to the date of the last
      menstrual period & confirmed ultrasonically, normal healthy women with average body mass
      index (BMI) and Women included have no medical disorder.

      Women who fulfilled the eligibility criteria were subjected an ultrasound fetal biometry
      every 2 weeks till delivery and assess fetal weight after delivery.
observational model: Cohort
time perspective: Prospective
measure: Fetal growth
time frame: through study completion ( from 28 weeks pregnancy till delivery)
description: assessment of the fetal growth biometry ( estimated fetal weight) every two weeks,
measure: neonatal weight
time frame: at the time of delivery of each participant
description: measured in grams after delivery
measure: mode of delivery
time frame: at the time of delivery of each participant
description: percentages of emergency CS due to presumed fetal compromise
arm group label: Totally fasting
description: Fasting each day from sunrise to sunset the whole month
arm group label: Partially fasting
description: means fasting from sunrise to sunset part of the month
arm group label: Non fasting
description: women who did not fast at all
intervention type: Behavioral
intervention name: Fasting
description: Totally or partially fasting the holy month of ramadan for muslims
arm group label: Partially fasting
arm group label: Totally fasting
study pop: 
sampling method: Probability Sample
criteria: 
gender: Female
minimum age: 20 Years
maximum age: 35 Years
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Principal Investigator
investigator affiliation: Ain Shams Maternity Hospital
investigator full name: AYMAN ABDELKADER MOHAMED ABDELKADER
investigator title: doctor
mesh term: Fetal Growth Retardation
sharing ipd: Yes
ipd description: no confidential data will be shared
ipd info type: Study Protocol
ipd info type: Clinical Study Report (CSR)
ipd time frame: december 2019
provided document: 
provided document: 