<?xml version="1.0" encoding="utf-8"?>
<!DOCTYPE trials [
<!ELEMENT trials (trial+)>

<!ELEMENT trial (main,contacts,countries,criteria,health_condition_code,health_condition_keyword,intervention_code,
          intervention_keyword,primary_outcome,secondary_outcome,secondary_sponsor,secondary_ids,source_support,ethics_reviews)>

<!ELEMENT main (trial_id,utrn?,reg_name,date_registration,primary_sponsor,public_title,acronym?,scientific_title,scientific_acronym?,
          date_enrolment,type_enrolment,target_size,recruitment_status,url?,study_type,study_design,phase,hc_freetext?,i_freetext?,results_actual_enrolment,results_date_completed,results_url_link,results_summary,           results_date_posted,results_date_first_publication,results_baseline_char,results_participant_flow,results_adverse_events,results_outcome_measures,results_url_protocol,results_IPD_plan, results_IPD_description)>
<!ELEMENT trial_id (#PCDATA)>
<!ELEMENT utrn (#PCDATA)>
<!ELEMENT reg_name (#PCDATA)>
<!ELEMENT date_registration (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT primary_sponsor (#PCDATA)>
<!ELEMENT public_title (#PCDATA)>
<!ELEMENT acronym (#PCDATA)>
<!ELEMENT scientific_title (#PCDATA)>
<!ELEMENT scientific_acronym (#PCDATA)>
<!ELEMENT date_enrolment (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT type_enrolment (#PCDATA)>
<!ELEMENT target_size (#PCDATA)>
<!ELEMENT recruitment_status (#PCDATA)><!-- Pending,Recruiting,Suspended,Complete,Other -->
<!ELEMENT url (#PCDATA)>
<!ELEMENT study_type (#PCDATA)><!-- interventional,observational -->
<!ELEMENT study_design (#PCDATA)>
<!ELEMENT phase (#PCDATA)>
<!ELEMENT hc_freetext (#PCDATA)>
<!ELEMENT i_freetext (#PCDATA)>
<!ELEMENT results_actual_enrolment (#PCDATA)>
<!ELEMENT results_date_completed (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_url_link (#PCDATA)>
<!ELEMENT results_summary (#PCDATA)>
<!ELEMENT results_date_posted (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_date_first_publication (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_baseline_char (#PCDATA)>
<!ELEMENT results_participant_flow (#PCDATA)>
<!ELEMENT results_adverse_events (#PCDATA)>
<!ELEMENT results_outcome_measures (#PCDATA)>
<!ELEMENT results_url_protocol (#PCDATA)>
<!ELEMENT results_IPD_plan (#PCDATA)>
<!ELEMENT results_IPD_description (#PCDATA)>


<!ELEMENT contacts (contact+)>
<!ELEMENT contact (type,firstname,middlename,lastname,address,city,country1,zip,telephone,email,affiliation)>
<!ELEMENT type (#PCDATA)><!-- Public,Scientific -->
<!ELEMENT firstname (#PCDATA)>
<!ELEMENT middlename (#PCDATA)>
<!ELEMENT lastname (#PCDATA)>
<!ELEMENT address (#PCDATA)>
<!ELEMENT city (#PCDATA)>
<!ELEMENT country1 (#PCDATA)>
<!ELEMENT zip (#PCDATA)>
<!ELEMENT telephone (#PCDATA)>
<!ELEMENT email (#PCDATA)>
<!ELEMENT affiliation (#PCDATA)>

<!ELEMENT countries (country2+)>
<!ELEMENT country2 (#PCDATA)>

<!ELEMENT criteria (inclusion_criteria,agemin,agemax,gender,exclusion_criteria)>
<!ELEMENT inclusion_criteria (#PCDATA)>
<!ELEMENT agemin (#PCDATA)>
<!ELEMENT agemax (#PCDATA)>
<!ELEMENT gender (#PCDATA)>
<!ELEMENT exclusion_criteria (#PCDATA)>

<!ELEMENT health_condition_code (hc_code+)>
<!ELEMENT hc_code (#PCDATA)>

<!ELEMENT health_condition_keyword (hc_keyword+)>
<!ELEMENT hc_keyword (#PCDATA)>

<!ELEMENT intervention_code (i_code+)>
<!ELEMENT i_code (#PCDATA)>

<!ELEMENT intervention_keyword (i_keyword+)>
<!ELEMENT i_keyword (#PCDATA)>

<!ELEMENT primary_outcome (prim_outcome+)>
<!ELEMENT prim_outcome (#PCDATA)>

<!ELEMENT secondary_outcome (sec_outcome+)>
<!ELEMENT sec_outcome (#PCDATA)>

<!ELEMENT secondary_sponsor (sponsor_name+)>
<!ELEMENT sponsor_name (#PCDATA)>

<!ELEMENT secondary_ids (secondary_id+)>
<!ELEMENT secondary_id (sec_id,issuing_authority)>
<!ELEMENT sec_id (#PCDATA)>
<!ELEMENT issuing_authority (#PCDATA)>

<!ELEMENT source_support (source_name+)>
<!ELEMENT source_name (#PCDATA)>

<!ELEMENT ethics_reviews (ethics_review+)>
<!ELEMENT ethics_review (status,approval_date,contact_name,contact_address,contact_phone,contact_email)>
<!ELEMENT status (#PCDATA)><!-- Not approved,Approved,NA -->
<!ELEMENT approval_date (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT contact_name (#PCDATA)>
<!ELEMENT contact_address (#PCDATA)>
<!ELEMENT contact_phone (#PCDATA)>
<!ELEMENT contact_email (#PCDATA)>
]>
<trials>
  <trial>
    <main>
      <trial_id>IRCT20170203032374N3</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-10-10</date_registration>
      <primary_sponsor>Vice Chancellor for Research and Technology of Guilan University of Medical Sciences</primary_sponsor>
      <public_title>Investigating  The Effect Of Olea Ointment On Cesarean Incision Local Pain And Healing In Mothers After Cesarian Cection</public_title>
      <acronym>ندارد</acronym>
      <scientific_title>Investigating  The Effect Of Olea Ointment On Cesarean Incision Local Pain And Healing In Mothers After Cesarian Cection</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-10-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>92</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/59199</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: Not, Randomization description: In This Study, By The Number Of Sample Volumes Required, Block Randomization With 4 And 6 Block Sizes Will Be Used To Randomize Sample In The Two Groups Of Olea Ointment And Placebo, Blinding description: The Present Study Will Be a Double-Blind, Randomized, Placebo-Controlled Clinical Trial. The Researcher And Research Units Will Be Unaware Of The Content Of Ointments Used. A Person Outside The Group Will Know The Content Of Ointments Used And Will Classify The Ointments According To A And B, Which Represent (Intervention And Placebo Group) And According To The Pre-Determined Random List, It Will Be Labeled On Ointments A And B And Packed In A Non-Transparent Envelope In The Order And Sequence, And Will Be Provided To The Researcher Inside The Box. Then, If They Are Satisfied, They Will Be Selected To Participate In The Study In An Accessible And Gradual Manner, And All Eligible Individuals Will Be Divided Into Two Groups Of Olea Ointment And Placebo According To The Specified Sequence, Using A Block Randomization Method With 4 And 6 Block Sizes. The Contents Of The Ointments Will Be Provided To The Research Units In Clean Containers Of One Shape and One Color And Free Of Charge.</study_design>
      <phase>N/A</phase>
      <hc_freetext>The Extent of Local Pain and Repair of Cesarean Section in Referring Mothers.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: The Intervention Group Will Be The Group Receiving Olea Ointment. First, The Researcher Will Be Taught How To Use The Ointment For The First Time, And Then The Samples Of The Intervention Group Will Be Asked To Place A Layer Of Olea Ointment On The Abdominal Cesarean Section Every 12 Hours And For At Least Two Minutes. Remain On The Skin And Then Cover The Wound With Sterile Gauze And Bandage. The First Intervention Will Be Performed By The Researcher 24 Hours After The Operation And The Next Interventions Will Be Performed By The Researcher During The Hospital Stay and After Discharging The Samples From The Hospital. It Will Be Done By The Person Himself. Intervention 2: Control group: The Placebo Group Will Receive A Placebo Ointment. First, The Researcher Is Taught How To Use The Ointment For The First Time, And Then The Samples Of The Intervention Group Are Asked To Put A Layer Of Ointment On The Abdominal Cesarean Section Every 12 Hours And On The Cesarean Section For At Least Two Minutes. The Skin Remains And Then The Wound Is Covered With Sterile Gauze AndThe First Intervention Will Be Performed By The Researcher 24 Hours After The Operation And The Next Interventions Will Be Performed By The Researcher During The Hospital Stay And After Discharge Of The Samples From The Hospital By The Person Will Do It Himself.</i_freetext>
      <results_actual_enrolment></results_actual_enrolment>
      <results_date_completed></results_date_completed>
      <results_url_link></results_url_link>
      <results_summary></results_summary>
      <results_date_posted></results_date_posted>
      <results_date_first_publication></results_date_first_publication>
      <results_baseline_char></results_baseline_char>
      <results_participant_flow></results_participant_flow>
      <results_adverse_events></results_adverse_events>
      <results_outcome_measures></results_outcome_measures>
      <results_url_protocol></results_url_protocol>
      <results_IPD_plan>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
The results of the data and the main consequences will be shared after the study in format of knowledge translation and exchange report to the university, presentation of reports in domestic or foreign conferences and seminars and publication of article in domestic or foreign scientiﬁc-research journals

When:
It is possible to access the study results after the defense and scientiﬁc conﬁrmation of the dissertation In a 3 months period

To whom:
if requested, results will be available to other academic investigators and Vice Chancellor for Research and Technology of Guilan University of Medical Sciences

Conditions:
The collected data is conﬁdential and will not be disclosed to other persons without the awareness of the Vice Chancellor for Research and Technology of the relevant university

Where to obtain:
To receive the documentation, send the email for update manager

How to obtain:
After the necessary checks, the desired documentary will be sent by email within one month period

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Fatemeh Jafarzadeh kenarsari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Nursing and Midwifery School of Shahid Dr. Beheshti, Hamidyan shahrak, Shahid Dr. Beheshti Ave., Rast, Guilan,Iran</address>
        <city>Rasht City</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>41469-39841</zip>
        <telephone>+98 13 3355 5058</telephone>
        <email>f.kenarsari2013@gmail.com</email>
        <affiliation>Nursing and Midwifery School of Shahid Dr. Beheshti</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Fatemeh Jafarzadeh kenarsari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Nursing and Midwifery School of Shahid Dr. Beheshti, Hamidyan shahrak, Shahid Dr. Beheshti Ave., Rasht, Guilan, IRAN</address>
        <city>Rasht</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>39841-41469</zip>
        <telephone>13 33555058,  13 33555056</telephone>
        <email>f.kenarsari2013@gmail.com</email>
        <affiliation>Shahid Beheshti School of Nursing and Midwifery</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Willingness And Satisfaction To Enter The Study
Cesarean Delivery In Al-Zahra Educational-Medical Center In Rasht and Langroud Shahid Hosseinpour Hospital
Primary And Multi-par Mothers With A History Of Two Cesarean Sections
Gestational Age 37 to 42 Weeks Depending On The Ultrasound Or The First Day Of The Last Period
Abdominal Incision Of Transverse Type
Maximum Rupture Time Of Membran Less Than 12 Hours
Minimum Literacy, Have A phone number To follow
Absence Of Systemic Diseases Including Diabetes And Cardiovascular Disease
Blood Pressure Coagulation Disorders During Or Before Pregnancy
No Postpartum Hemorrhage
No Blood Transfusion In Surgery
Do Not Take Certain Medications That Increase The Risk Of Postpartum Infection</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Misuse Of Olea Ointment By Research Units
Allergy To Ointment During the Study
Concomitant Use Of Other Ointments Or Topical Medications</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>090.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>•  O85-O92 Complications Predominantly Related To the PuerperiumO86.0 Infection of Obstetric Surgical Wound. Infected	Caesarean Section Wound Followimg Delivery</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: The Intervention Group Will Be The Group Receiving Olea Ointment. First, The Researcher Will Be Taught How To Use The Ointment For The First Time, And Then The Samples Of The Intervention Group Will Be Asked To Place A Layer Of Olea Ointment On The Abdominal Cesarean Section Every 12 Hours And For At Least Two Minutes. Remain On The Skin And Then Cover The Wound With Sterile Gauze And Bandage. The First Intervention Will Be Performed By The Researcher 24 Hours After The Operation And The Next Interventions Will Be Performed By The Researcher During The Hospital Stay and After Discharging The Samples From The Hospital. It Will Be Done By The Person Himself</i_keyword>
      <i_keyword>Control group: The Placebo Group Will Receive A Placebo Ointment. First, The Researcher Is Taught How To Use The Ointment For The First Time, And Then The Samples Of The Intervention Group Are Asked To Put A Layer Of Ointment On The Abdominal Cesarean Section Every 12 Hours And On The Cesarean Section For At Least Two Minutes. The Skin Remains And Then The Wound Is Covered With Sterile Gauze AndThe First Intervention Will Be Performed By The Researcher 24 Hours After The Operation And The Next Interventions Will Be Performed By The Researcher During The Hospital Stay And After Discharge Of The Samples From The Hospital By The Person Will Do It Himself.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The Extent of Local Pain and Repair of Cesarean Section in The Referring Mothers. Timepoint: The Severity of Pain Before With the Visual Scale of Pain Ruler and The Condition of Abdominal Incision Improvement Are Also Evaluated And Recorded By The Researcher Using The Reeda Scale Before The Intervention, 24 Hours After The First Intervention And On Days 5 And 10 After Cesarean Section. Method of measurement: Visual Analogue Scale (VAS) and Reeda.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name></sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Vice Chancellor for Research and Technology of Guilan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-09-29</approval_date>
        <contact_name>Ethics committee of Guilan University of Medical Sciences</contact_name>
        <contact_address>Deputy of Research and Technology of Gilan University of Medical Sciences, in front of 17 Shahrivar Hospital, Shahid Siadati Ave., Namjoo St. Rasht Guilan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
