<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/NCT03272282</url>
  </required_header>
  <id_info>
    <org_study_id>paperlesspartograph</org_study_id>
    <nct_id>NCT03272282</nct_id>
  </id_info>
  <brief_title>Paperless Parotograph in Evaluation of Labour</brief_title>
  <acronym>labourRecord</acronym>
  <official_title>Paperless Partograph Evaluation of Labour</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assiut University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assiut 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>
      Using Paperless partograph management of labour as simple tool to prevent obstructed labour&#xD;
      or prolonged labour or its complications at the mother or her fetus&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      WHO PARTOGRAPH is very work load need more time and more stuff in both treaning and learning&#xD;
      for plotting and for drowning but inside labour room needing simple partograph playing the&#xD;
      simple partograph beast role in management of labour and stand test against time for saving&#xD;
      live of labour women and her child Paperless parotograph can help obestitricianes to talk&#xD;
      decision about when to transferr the labourus women to higher centers on to make medical&#xD;
      intervention or what time to end labour by caesarian section&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">January 12, 2017</start_date>
  <completion_date type="Anticipated">September 12, 2017</completion_date>
  <primary_completion_date type="Anticipated">September 12, 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Crossover</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Progress of labour</measure>
    <time_frame>up to 5 months</time_frame>
    <description>Cervical dilatation 1 cm / hour</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Charcteristics of new_born</measure>
    <time_frame>up to 1 month</time_frame>
    <description>Apgar score at1minute and Apgar score at 5minutes</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time taken after ALERT EDT</measure>
    <time_frame>up to 2 months</time_frame>
    <description>Primgravida and Multipara</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Mode of delivery</measure>
    <time_frame>up to 9 weeks</time_frame>
    <description>Normal vaginal delivery or caesarean section</description>
  </other_outcome>
  <enrollment type="Anticipated">450</enrollment>
  <condition>Labor Complication</condition>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      By fellowing women during labour when cervical dilation reach 4cm in active phase of labour&#xD;
      all women with inclusion criteria are recorded all women with exclusion criteria are excluded&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        By following women during labour using well structured questions developed by researcher&#xD;
        and filling well designed Paperless partograph stumped THE collected data will be analysed&#xD;
        using special computer program SPSS tactical program for social science&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  women ln active phase of labour&#xD;
&#xD;
          -  With single pregnanncy&#xD;
&#xD;
          -  living fetus&#xD;
&#xD;
          -  cephalic presentation&#xD;
&#xD;
          -  occipt anterior&#xD;
&#xD;
          -  36 weak gestional age up to full term&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  preterm . .or women with antipartum hemorrhage .&#xD;
&#xD;
          -  or multipregnanncy&#xD;
&#xD;
          -  previous utrine surgery&#xD;
&#xD;
          -  or abnormal cardiotocograph(CTG )PATTERN&#xD;
&#xD;
          -  or any heart disease of mother or his fetus&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Women ln active phase of labour cerivical dilution 4cm or more</gender_description>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>42 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>mohamed khalaph</last_name>
    <role>Study Director</role>
    <affiliation>assiut universty faculity of medicine</affiliation>
  </overall_official>
  <overall_official>
    <last_name>ahmad abass</last_name>
    <role>Study Chair</role>
    <affiliation>assiut university faclity of meficibe</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>abobaker khalil</last_name>
    <phone>00201003568474</phone>
    <email>kotbnetw@hotmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>said mostafa</last_name>
    <phone>00201007599819</phone>
    <email>saidmostafy9@gmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Faculity of Medicine Assiut University</name>
      <address>
        <city>Asyūţ</city>
        <state>Assiut</state>
        <zip>71723</zip>
        <country>Egypt</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>abo baker, pro</last_name>
      <phone>00201003568474</phone>
      <email>kotbnetw@hotmail.com</email>
    </contact>
    <contact_backup>
      <last_name>said mostafa, pro</last_name>
      <phone>00201007599819</phone>
      <email>saidmostafy9@gmail.com</email>
    </contact_backup>
    <investigator>
      <last_name>ayman darder, dr</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Faculity of Medicine</name>
      <address>
        <city>Assiut</city>
        <zip>71723</zip>
        <country>Egypt</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>abobaker khalil abass metwally, professor</last_name>
      <phone>002010033568474</phone>
      <email>kotbnetw@hotmail.com</email>
    </contact>
    <contact_backup>
      <last_name>said mohamed mostafy, profossor</last_name>
      <phone>00201007599819</phone>
      <email>saidmostafy9@gmail.com</email>
    </contact_backup>
    <investigator>
      <last_name>ayman darder abed algwad mohamed, specialest</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <link>
    <url>http://www.iiste.org/journals</url>
    <description>more information can present in thishomepage</description>
  </link>
  <results_reference>
    <citation>Fatehi F, Gray LC, Wootton R. How to improve your PubMed/MEDLINE searches: 3. advanced searching, MeSH and My NCBI. J Telemed Telecare. 2014 Mar;20(2):102-12. doi: 10.1177/1357633X13519036.</citation>
    <PMID>24614997</PMID>
  </results_reference>
  <results_reference>
    <citation>Jadad AR, McQuay HJ. Searching the literature. Be systematic in your searching. BMJ. 1993 Jul 3;307(6895):66. doi: 10.1136/bmj.307.6895.66-a. No abstract available.</citation>
    <PMID>8343701</PMID>
  </results_reference>
  <results_reference>
    <citation>Chang AA, Heskett KM, Davidson TM. Searching the literature using medical subject headings versus text word with PubMed. Laryngoscope. 2006 Feb;116(2):336-40. doi: 10.1097/01.mlg.0000195371.72887.a2.</citation>
    <PMID>16467730</PMID>
  </results_reference>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>August 23, 2017</study_first_submitted>
  <study_first_submitted_qc>August 31, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 5, 2017</study_first_posted>
  <last_update_submitted>September 1, 2017</last_update_submitted>
  <last_update_submitted_qc>September 1, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 6, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Assiut University</investigator_affiliation>
    <investigator_full_name>ayman darder</investigator_full_name>
    <investigator_title>principal investigator</investigator_title>
  </responsible_party>
  <keyword>WHO PARTOGRAPG.OBSTRUCTED LABOUR. managment of labour</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Obstetric Labor Complications</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <study_docs>
    <study_doc>
      <doc_id>prospective auther of journals</doc_id>
      <doc_type>Study Protocol</doc_type>
      <doc_url>http://www.iiste.org/journals/</doc_url>
      <doc_comment>All the journals articles are amiable online to the reader all over the world without financially legal barriers</doc_comment>
    </study_doc>
  </study_docs>
  <!-- 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/NCT03272282
org study id: paperlesspartograph
nct id: NCT03272282
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Using Paperless partograph management of labour as simple tool to prevent obstructed labour
      or prolonged labour or its complications at the mother or her fetus
WHO PARTOGRAPH is very work load need more time and more stuff in both treaning and learning
      for plotting and for drowning but inside labour room needing simple partograph playing the
      simple partograph beast role in management of labour and stand test against time for saving
      live of labour women and her child Paperless parotograph can help obestitricianes to talk
      decision about when to transferr the labourus women to higher centers on to make medical
      intervention or what time to end labour by caesarian section
observational model: Case-Crossover
time perspective: Prospective
measure: Progress of labour
time frame: up to 5 months
description: Cervical dilatation 1 cm / hour
measure: Charcteristics of new_born
time frame: up to 1 month
description: Apgar score at1minute and Apgar score at 5minutes
measure: Time taken after ALERT EDT
time frame: up to 2 months
description: Primgravida and Multipara
measure: Mode of delivery
time frame: up to 9 weeks
description: Normal vaginal delivery or caesarean section
By fellowing women during labour when cervical dilation reach 4cm in active phase of labour
      all women with inclusion criteria are recorded all women with exclusion criteria are excluded
study pop: 
sampling method: Probability Sample
criteria: 
gender: Female
gender based: Yes
gender description: Women ln active phase of labour cerivical dilution 4cm or more
minimum age: 20 Years
maximum age: 42 Years
healthy volunteers: Accepts Healthy Volunteers
last name: mohamed khalaph
role: Study Director
affiliation: assiut universty faculity of medicine
last name: ahmad abass
role: Study Chair
affiliation: assiut university faclity of meficibe
last name: abobaker khalil
phone: 00201003568474
email: kotbnetw@hotmail.com
last name: said mostafa
phone: 00201007599819
email: saidmostafy9@gmail.com
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
country: Egypt
url: http://www.iiste.org/journals
description: more information can present in thishomepage
citation: Fatehi F, Gray LC, Wootton R. How to improve your PubMed/MEDLINE searches: 3. advanced searching, MeSH and My NCBI. J Telemed Telecare. 2014 Mar;20(2):102-12. doi: 10.1177/1357633X13519036.
PMID: 24614997
citation: Jadad AR, McQuay HJ. Searching the literature. Be systematic in your searching. BMJ. 1993 Jul 3;307(6895):66. doi: 10.1136/bmj.307.6895.66-a. No abstract available.
PMID: 8343701
citation: Chang AA, Heskett KM, Davidson TM. Searching the literature using medical subject headings versus text word with PubMed. Laryngoscope. 2006 Feb;116(2):336-40. doi: 10.1097/01.mlg.0000195371.72887.a2.
PMID: 16467730
responsible party type: Principal Investigator
investigator affiliation: Assiut University
investigator full name: ayman darder
investigator title: principal investigator
mesh term: Obstetric Labor Complications
sharing ipd: No
study doc: 