<?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>IRCT2017020332374N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2017-10-05</date_registration>
      <primary_sponsor>Guilan University of Medical Sciences</primary_sponsor>
      <public_title>The effect of  Olea ointment and  Lidocaine Gel 2 % on pain relieving and episiotomy wound healing</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of Olea ointment and 2 % Lidocaine Gel on pain relieving and episiotomy wound healing in primiparous women</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-09-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>123</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/25248</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>2-3</phase>
      <hc_freetext>Episiotomy.</hc_freetext>
      <i_freetext>Intervention 1: Olea Ointment (First intervention group): This ointment is made in Farateb Company, Yazd,Iran. Its ingredients are:10 g Olive Oil, 10g Sesame, and 10 g honey.This ointment is available in 30 gram tubes.Four hours after episiotomy, the first intervention will be applied by the researcher. After that, the intervention groups will be asked to put some Olea ointment on the sutures at bedtime and use a sanitary pad after 1-2 minutes, and then repeat it every 24 h till 10th day after childbirth. Intervention 2: Lidocaine gel 2% (Second intervention Group) is made in Razi Drug Company, Tehran, Iran. Four hours after episiotomy, the first intervention will be applied by the researcher. After that, the intervention groups will be asked to put some  Lidocaine gel 2% on the sutures at bedtime and use a sanitary pad after 1-2 minutes, and then repeat it every 24 h till 10th day after childbirth. Both intervention groups will also use routine care (use of Normal Saline twice a day). Intervention 3: Normal Saline 0.9 % (Control Group), non-injectable, made in Parsdaro Co, Tehran,Iran. The Control group will only use Normal Saline twice a day till 10th day after childbirth.</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></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr. FATEMEH JAFARZADEH-KENARSARI</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>East Guilan Nursing and Midwifery -Langroud-Guilan-Iran</address>
        <city>Langroud</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>98</zip>
        <telephone>+98 13 4256 5058</telephone>
        <email>f.kenarsari2013@gmail.com</email>
        <affiliation>GUILAN UNIVERSITY OF MEDICAL SCIENCES</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Fatemeh Jafarzadeh-Kenarsari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Rasht-Guilan-Iran</address>
        <city>Rasht</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>98</zip>
        <telephone>+98 13 4256 5058</telephone>
        <email>f.kenarsari2013@gmail.com</email>
        <affiliation>Guilan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criterias: Iranian patients;  Primiparous;  18-35 years old; Literate; Volunteer; Term pregnancy with single fetus; Cephalic presentation; Mediolateral episiotomy; Newborn weight about 2500-4000 g; Absence of diseases affecting wound healing; Lack of PROM longer than 18 hours; The maternal BMI range between 19/8 and 30.&#13;
Exclusion criteria: Unwillingness to continue to participate in the study; The use of other effective drugs for wound healing during the study; Inappropriate use of medications (more than two nights); Allergy to the Olea ointment or Lidocaine gel 2%; Failure to go to hospital on days 5 and 10 after delivery; Having a sexual relationship in the first five days after childbirth.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>35 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>O70.0, O70</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>First degree perineal laceration during delivery,Second degree perineal laceration during delivery</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Olea Ointment (First intervention group): This ointment is made in Farateb Company, Yazd,Iran. Its ingredients are:10 g Olive Oil, 10g Sesame, and 10 g honey.This ointment is available in 30 gram tubes.Four hours after episiotomy, the first intervention will be applied by the researcher. After that, the intervention groups will be asked to put some Olea ointment on the sutures at bedtime and use a sanitary pad after 1-2 minutes, and then repeat it every 24 h till 10th day after childbirth.</i_keyword>
      <i_keyword>Lidocaine gel 2% (Second intervention Group) is made in Razi Drug Company, Tehran, Iran. Four hours after episiotomy, the first intervention will be applied by the researcher. After that, the intervention groups will be asked to put some  Lidocaine gel 2% on the sutures at bedtime and use a sanitary pad after 1-2 minutes, and then repeat it every 24 h till 10th day after childbirth. Both intervention groups will also use routine care (use of Normal Saline twice a day).</i_keyword>
      <i_keyword>Normal Saline 0.9 % (Control Group), non-injectable, made in Parsdaro Co, Tehran,Iran. The Control group will only use Normal Saline twice a day till 10th day after childbirth.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Severity of episiotomy pain. Timepoint: Before intervention; 2 h and 24 h after first intervention; 5th and 10th days of postpartum. Method of measurement: pain visual scale.</prim_outcome>
      <prim_outcome>Episiotomy wound healing. Timepoint: Before intervention; 2 h and 24 h after first intervention; 5th and 10th days of postpartum. Method of measurement: REEDA Scale.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Drug side effects. Timepoint: 2h after first intervention; 24h after first intervention; 5th and 10th days of postpartum. Method of measurement: Drug side effects Form.</sec_outcome>
      <sec_outcome>Maternal health condition. Timepoint: 2h after first intervention; 24h after first intervention; 5th and 10th days of postpartum. Method of measurement: Maternal health condition Form.</sec_outcome>
      <sec_outcome>Used analgesic. Timepoint: 2h after first intervention; 24h after first intervention; 5th and 10th days of postpartum. Method of measurement: Used analgesic Form.</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>Guilan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-08-05</approval_date>
        <contact_name>Guilan University of Medical Sciences</contact_name>
        <contact_address>Guilan University of Medical Sciences-Rasht-Iran Rasht  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
