<?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>IRCT201405318801N8</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2014-09-10</date_registration>
      <primary_sponsor>ْShahid Beheshti University of Medical Sciences</primary_sponsor>
      <public_title>Comparison of the effect of  phenytoin Cream and Honey Cream  on episiotomy pain and healing of episiotomy</public_title>
      <acronym>-</acronym>
      <scientific_title>Compare the effect phenytoin cream and  honey  cream on pain and healing of episiotomy in nulliparous women</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2014-02-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>120</target_size>
      <recruitment_status>Other</recruitment_status>
      <url>https://irct.ir/trial/9289</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: -.</study_design>
      <phase>2-3</phase>
      <hc_freetext>Episiotomy pain and wound healing.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: phenytoin sodium, 1% Topical Cream, Once a day.&#13;
Mothers were asked the night before sleep, after washing and drying the perineal area once a phalanx of ointment on the affected area is sutured So that it covers the particularity and after 1-2 minutes and do a clean pad and  every 24 hours until the tenth day after delivery. Intervention 2: Intervention group: Honey cream, 30%. Once a day. Mothers were asked the night before sleep, after washing and drying the perineal area once a phalanx of ointment on the affected area is sutured So that it covers the particularity and after 1-2 minutes and do a clean pad and  every 24 hours until the tenth day after delivery. Intervention 3: Control group: Placebo, the cream base color and odor as similar to the intervention group. Once a day. Mothers were asked the night before sleep, after washing and drying the perineal area once a phalanx of ointment on the affected area is sutured So that it covers the particularity and after 1-2 minutes and do a clean pad and  every 24 hours until the tenth day after delivery.</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>Masoumeh Simbar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Research Council, Third Floor, School of Nursing and Midwifery Shahid Beheshti, front of Rajaii Hospital, Intersections of Vali Asr and Niayesh, above of Mirdamad, Vali Asr Street, Tehran.  code post: 1996835119, tel: 88202516.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1996835119</zip>
        <telephone>+98 21 8820 2516</telephone>
        <email>msimbar@sbmu.ac.ir</email>
        <affiliation>School of Nursing and Midwifery Shahid Beheshti</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Masoumeh Simbar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Research Council, Third Floor, School of Nursing and Midwifery Shahid Beheshti, front of Rajaii Hospital, Intersections of Vali Asr and Niayesh, above of Mirdamad, Vali Asr Street, Tehran.  code post: 1996835119, tel: 88202516.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1996835119</zip>
        <telephone>+98 21 8820 2516</telephone>
        <email>sbnmf@sbmu.ac.irmsimbar@sbmu.ac.ir</email>
        <affiliation>School of Nursing and Midwifery Shahid  Beheshti</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: &#13;
Term and Nulliparous Pregnancy; A literate, between 18-35 of age; race  Persia; Living in Kashan; a live singleton fetus with cephalic presentation; birth weight between 2500-4000 grams; BMI  In the range of 19.8 to 30; The lack of effect on wound healing drugs (anticoagulants, antidepressants, anticonvulsants, alcohol, glucocorticoids, suppression of the immune system, antibiotics and chemotherapy); narcotics and psychotropic drugs; Disturbing lack of healing diseases (chronic, systemic, cardiac, renal, pulmonary, coagulation disorders, immune deficiency, connective tissue disorders, diabetes, anemia, psychiatric disease, hemophilia, depression, malnutrition) and no history of injury, or previous surgery of lesions visible in the perineum (genital warts, hemorrhoids), persistent constipation; Lack PROM more than 18 hours;  lack a history of reactions to local anesthetics or lidocaine; absence of bleeding after childbirth; lack of manual removal of the placenta; the absence of perineal hematoma; No manipulation of the perineum after delivery; failure or anomaly NICU baby; for more than 14 hours not take delivery of the first stage, second stage of labor greater than 2 hours to not take, the third stage of labor not take more than half an hour. Exclusion Criteria: &#13;
Drugs affecting the healing of wounds (anticoagulants, antidepressants, anticonvulsants, alcohol Glkvkvrtykvyydha, suppressing the immune system, antibiotics and chemotherapy) during the study; Not used regularly and as directed cream; creams desired sensitivity; lack of desire to continue participating in the study; having sex in the first five days after birth; coming to the clinic.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>35 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>o70.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>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>Intervention group: phenytoin sodium, 1% Topical Cream, Once a day.&#13;
Mothers were asked the night before sleep, after washing and drying the perineal area once a phalanx of ointment on the affected area is sutured So that it covers the particularity and after 1-2 minutes and do a clean pad and  every 24 hours until the tenth day after delivery</i_keyword>
      <i_keyword>Intervention group: Honey cream, 30%. Once a day. Mothers were asked the night before sleep, after washing and drying the perineal area once a phalanx of ointment on the affected area is sutured So that it covers the particularity and after 1-2 minutes and do a clean pad and  every 24 hours until the tenth day after delivery.</i_keyword>
      <i_keyword>Control group: Placebo, the cream base color and odor as similar to the intervention group. Once a day. Mothers were asked the night before sleep, after washing and drying the perineal area once a phalanx of ointment on the affected area is sutured So that it covers the particularity and after 1-2 minutes and do a clean pad and  every 24 hours until the tenth day after delivery.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain Intensity. Timepoint: First 24 hours after delivery (baseline value) - Seven days after the intervention - fourteen days after the intervention. Method of measurement: Pain ruler.</prim_outcome>
      <prim_outcome>Episiotomy wound healing. Timepoint: First 24 hours after delivery (baseline value) - Seven days after the intervention - fourteen days after the intervention. Method of measurement: Control by improving the perineum (the scale Reeda).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Stiffness. Timepoint: First 24 hours after childbirth, the postpartum seventh day, the fourteenth day after delivery. Method of measurement: Questionnaire.</sec_outcome>
      <sec_outcome>Irritation. Timepoint: First 24 hours after childbirth, the postpartum seventh day, the fourteenth day after delivery. Method of measurement: Questionnaire.</sec_outcome>
      <sec_outcome>Itching. Timepoint: First 24 hours after childbirth, the postpartum seventh day, the fourteenth day after delivery. Method of measurement: Questionnaire.</sec_outcome>
      <sec_outcome>Dryness. Timepoint: First 24 hours after childbirth, the postpartum seventh day, the fourteenth day after delivery. Method of measurement: Questionnaire.</sec_outcome>
      <sec_outcome>Discharge from the wound. Timepoint: First 24 hours after childbirth, the postpartum seventh day, the fourteenth day after delivery. Method of measurement: Questionnaire.</sec_outcome>
      <sec_outcome>Fever and chills. Timepoint: First 24 hours after childbirth, the postpartum seventh day, the fourteenth day after delivery. Method of measurement: Questionnaire.</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>ْShahid Beheshti University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2013-12-30</approval_date>
        <contact_name>Shahid Beheshti University for Medical Sciences</contact_name>
        <contact_address>tehran,shahid  chamran high way, yaman street, next of taleghani hospitol, Nursing and Midwifery of  Shahid Beheshti  univercity Tehran  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
