<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/NCT03276117</url>
  </required_header>
  <id_info>
    <org_study_id>paperless partograph</org_study_id>
    <nct_id>NCT03276117</nct_id>
  </id_info>
  <brief_title>Wide Use of Paperless Partograph in Evaluation of Labour</brief_title>
  <acronym>labourRecord</acronym>
  <official_title>Wide Using of Paperless Partograph in 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>
      Paperless partograph wide using in labour room as simple tool in evaluation of labour&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Both world health organization ( WHO) PARTOGRAPH and modified world heath organization&#xD;
      (WHO)PARTOGRAPH are too long labour tools in evaluation of labour so we need simple tool in&#xD;
      evaluation of labour&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 2, 2017</start_date>
  <completion_date type="Actual">August 26, 2017</completion_date>
  <primary_completion_date type="Actual">August 21, 2017</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>Progress of labour</measure>
    <time_frame>up to 2 month</time_frame>
    <description>Cervical dilated 1 cm each hour</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>New born</measure>
    <time_frame>up to 1 month</time_frame>
    <description>Apgar scor at 1 minute and Apgar scor at 5 minutes</description>
  </secondary_outcome>
  <enrollment type="Actual">200</enrollment>
  <condition>Labor Complication</condition>
  <condition>Labor Pain</condition>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Inside labour room we record that when the labour women in active phase as cervical&#xD;
      dilatation 4cm or more&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        the collected data wail be analyzed using the statistical package for social science&#xD;
        (version 10.0 for windows,SPSS.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Spontaneous labour&#xD;
&#xD;
          -  cephalic presentation&#xD;
&#xD;
          -  pregnant 37 weeks up to full term&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  mail_presentation&#xD;
&#xD;
          -  induced labour&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>25 Years</minimum_age>
    <maximum_age>35 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>mohamed khalaph, professor</last_name>
    <role>Study Chair</role>
    <affiliation>assiut universty faculity of medicine</affiliation>
  </overall_official>
  <overall_official>
    <last_name>ahmad abass, professor</last_name>
    <role>Principal Investigator</role>
    <affiliation>assiut university faclity of meficibe</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Faculity of Medicine ,in Assiut,Egypt</name>
      <address>
        <city>Assiut</city>
        <zip>71723</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Faculity of Medicine Assiut University</name>
      <address>
        <city>Assiut</city>
        <zip>71723</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Faculity of Medicine in Assiut,Egypt</name>
      <address>
        <city>Assiut</city>
        <zip>71723</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Faculity of Medicine,in Assiut ,Egypt</name>
      <address>
        <city>Assiut</city>
        <zip>71723</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Faculity of Medicine,in Assiut,Egypt</name>
      <address>
        <city>Assiut</city>
        <zip>71723</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Faculity of Medicine</name>
      <address>
        <city>Assiut</city>
        <zip>71723</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <link>
    <url>http://www.iiste.org/journals/</url>
    <description>all the journals articles are available online to the readers all over the world without legal barriers</description>
  </link>
  <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>
  <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>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>September 4, 2017</study_first_submitted>
  <study_first_submitted_qc>September 6, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 8, 2017</study_first_posted>
  <last_update_submitted>September 6, 2017</last_update_submitted>
  <last_update_submitted_qc>September 6, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 8, 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>pregnancy.obstructed labour</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Obstetric Labor Complications</mesh_term>
    <mesh_term>Labor Pain</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03276117
org study id: paperless partograph
nct id: NCT03276117
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Paperless partograph wide using in labour room as simple tool in evaluation of labour
Both world health organization ( WHO) PARTOGRAPH and modified world heath organization
      (WHO)PARTOGRAPH are too long labour tools in evaluation of labour so we need simple tool in
      evaluation of labour
observational model: Cohort
time perspective: Prospective
measure: Progress of labour
time frame: up to 2 month
description: Cervical dilated 1 cm each hour
measure: New born
time frame: up to 1 month
description: Apgar scor at 1 minute and Apgar scor at 5 minutes
Inside labour room we record that when the labour women in active phase as cervical
      dilatation 4cm or more
study pop: 
sampling method: Probability Sample
criteria: 
gender: Female
minimum age: 25 Years
maximum age: 35 Years
healthy volunteers: Accepts Healthy Volunteers
last name: mohamed khalaph, professor
role: Study Chair
affiliation: assiut universty faculity of medicine
last name: ahmad abass, professor
role: Principal Investigator
affiliation: assiut university faclity of meficibe
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Egypt
url: http://www.iiste.org/journals/
description: all the journals articles are available online to the readers all over the world without legal barriers
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
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
responsible party type: Principal Investigator
investigator affiliation: Assiut University
investigator full name: ayman darder
investigator title: principal investigator
mesh term: Obstetric Labor Complications
mesh term: Labor Pain
sharing ipd: Undecided