<?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>IRCT20181007041267N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-08-07</date_registration>
      <primary_sponsor>Ahvaz University of Medical Sciences</primary_sponsor>
      <public_title>Effect of raspberry on episiotomy</public_title>
      <acronym></acronym>
      <scientific_title>Effect of raspberry ointment on epistolary ulcer in Primal woman</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-01-11</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>120</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/34515</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The sampling method is targeted to female patients referring to Al Hadi hospital in Shoushtar. After reviewing the criteria for entering the study, allocation of individuals to groups is done using random block assignment, Blinding description: Blinding is related to research and analysis. In order to blindness, the random allocation of the units study will be done in two groups of control and intervention and will be followed by the midwife.</study_design>
      <phase>3</phase>
      <hc_freetext>episiotomy sore.</hc_freetext>
      <i_freetext>Intervention 1: "Intervention group:" The raspberry ointment was after the pharmaceutical stages prepared and selected as an intervention medicine. It will be in empty tubes. After washing and drying the perineum, phalange ointment put on the perina area, So that they cover it and use a clean sanitary pad after 1-2 minutes, and continue to do this 2 times a day, morning and night before bedtime until the 14th day after childbirth. Exit from the wound, severe pain in the perineum, excessive periosteum, perineal area, burning, itching, stiffness and dandruff in the wound area with the researcher to investigate and take necessary action. Also, in the form of the registration of side effects, based on the questions asked, Note the complication. The status of mothers' episiotomy improvement during the 7th, 10th and 14th days after delivery will be investigated by the researcher based on the objective evaluation of the REEDA wound and the VAZE visual inspection tool. Intervention 2: control group: Use of routine hospital practice And without any additional action(washed with diluted iodine) twice a day for 1 week and The status of mothers' episiotomy improvement during the 7th, 10th and 14th days after delivery will be investigated by the researcher based on the objective evaluation of the REEDA wound and the VAZE visual inspection t.</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>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is After printing the article</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Forough Boustani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shoushtar faculty Medical of Sciences. Al Hadi hospital. BLV Rajaee</address>
        <city>Shoushtar</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6451675943</zip>
        <telephone>+98 61 3622 9325</telephone>
        <email>stu.boostani72@gmail.com</email>
        <affiliation>Shoushtar School of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Forough Boustani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shoushtar faculty Medical of Sciences. Al Hadi hospital. BLV Rajaee</address>
        <city>Shoushtar</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6451675943</zip>
        <telephone>+98 61 3622 9325</telephone>
        <email>stu.boostani72@gmail.com</email>
        <affiliation>Shoushtar School of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Iranian race and resident of Shushtar                                                 Primipara with age between 18-35 years                                                      Have a reading and writing literacy                                                                                                       Term pregnancy with live birth defects                                            Baby weight between 4000-2500 grams                                           Body mass index ranging from 29.9 to 19.9                                      No use of effective medications for mother's wound healing          No rupture of the bag for more than 18 hours                                   No postpartum hemorrhage                                                            No pairing out of hand                                                                                                                        The lack of perineal hematoma                                                         Failure to reintroduce perineal after delivery                                    Absence of newborn bedridden or neonatal anomalies                   Not having cystocele and severe rectus in the vagina                                                No history of reconstructive surgery on the vagina and midwifery</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>35 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Disturbances in the progress of labor                                                            The length of the second stage of delivery is more than 2 hours               Abnormal vaginal bleeding                                                                        Perform curettage or anesthesia in the first 24 hours after delivery                                                                                                  Presence of fever                                                                               Episiotomy site infection                                                                     Need to suture again with episiotomy                                               Use of drugs that affect wound healing during the study                 Do not use ointment regularly and in accordance with instructions                                                                                                                 Sensitization to the desired ointment                                                            Unwillingness to continue to participate in the study                       Have sex during the first five days after delivery                              Failure to go to the clinic of the hospital or the nearest clinic to the person's home on the seventh, tenth and fourteenth day after childbirth                                                                                             Existence of extension of cutting length                                           Abnormal vaginal bleeding                                                                Shoulder Dystopia</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>o90.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Disruption of perineal obstetric wound</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 raspberry ointment was after the pharmaceutical stages prepared and selected as an intervention medicine. It will be in empty tubes. After washing and drying the perineum, phalange ointment put on the perina area, So that they cover it and use a clean sanitary pad after 1-2 minutes, and continue to do this 2 times a day, morning and night before bedtime until the 14th day after childbirth. Exit from the wound, severe pain in the perineum, excessive periosteum, perineal area, burning, itching, stiffness and dandruff in the wound area with the researcher to investigate and take necessary action. Also, in the form of the registration of side effects, based on the questions asked, Note the complication. The status of mothers' episiotomy improvement during the 7th, 10th and 14th days after delivery will be investigated by the researcher based on the objective evaluation of the REEDA wound and the VAZE visual inspection tool.</i_keyword>
      <i_keyword>control group: Use of routine hospital practice And without any additional action(washed with diluted iodine) twice a day for 1 week and The status of mothers' episiotomy improvement during the 7th, 10th and 14th days after delivery will be investigated by the researcher based on the objective evaluation of the REEDA wound and the VAZE visual inspection t</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Effect of raspberry ointment on episiotomy ulcer. Timepoint: On days 7.10.14 after delivery. Method of measurement: Questionnaire by Rida and Lazar Waz.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>The effect of raspberry ointment on the reduction of episiotomy redness                    Effect of raspberry ointment on decreasing episiotomy size Reduction of episiotomy bruises of raspberry ointment on reducing the amount of secretion from episiotomy ulcer Ointment of raspberry on reducing the amount of two-edges of episiotomy ulcer of raspberry ointment on reducing the degree of score of the pain of episiotomy ulcers. Timepoint: On days 7.10.14 after delivery. Method of measurement: Visual Analogue Scale and analyse the Redness, Oedema, Ecchymosis, Discharge, Approximation.</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>Ahvaz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2016-11-05</approval_date>
        <contact_name>Ethics committee of shoushtar faculty medical of sciences</contact_name>
        <contact_address>shoushtar faculty medical of sciences shoushtar Khouzestan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
