<?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>IRCT20231007059638N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2024-01-28</date_registration>
      <primary_sponsor>Shahid Beheshti University of Medical Sciences</primary_sponsor>
      <public_title>Evaluation the effect of of ostrich oil on pain intensity and episiotomy wound healing</public_title>
      <acronym></acronym>
      <scientific_title>Evaluation the effect of of ostrich oil on pain intensity and episiotomy wound healing in primiparous women</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2024-02-09</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>112</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/72987</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Factorial, Purpose: Treatment, Randomization description: The function of random numbers is used to randomize and assign people to groups. The samples will be randomly entered into two intervention and control groups by three-blind random allocation method using Excel software, Blinding description: In this intervention, the researcher, the statistical analyst and the participants (primiparous mothers) are kept blind to the allocation of the study groups (triple-blind). In this way, the oils will be prepared and coded by the doctor of pharmacology in the same shape, color and smell, the researcher will not know the nature of the package and will receive the packages. After obtaining informed consent from the samples and explaining the research to them, the packages will be provided to the samples. After collecting the data, the statistical analyst is also unaware of which group (control or intervention) each of the samples is in.</study_design>
      <phase>3</phase>
      <hc_freetext>Episiotomy.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Ostrich oil will be prepared in 30 gram oil tubes containing ostrich oil to be used twice a day for two centimeters on the episiotomy suture for ten days after delivery. In this way, ostrich oil will be purchased from the pharmaceutical market and these tubes will be filled and autoclaved by the respected pharmaceutical consultant. Intervention 2: Control group: Placebo oil contains an oil-based material (oserin) that is identical in shape, color, and consistency to the drug, in 30-gram oil tubes to be applied twice daily two centimeters across the episiotomy suture for ten days postpartum. will be prepared. Oserin oil will be purchased from the pharmaceutical market and these tubes will be filled and autoclaved by the respected pharmaceutical consultant.</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 Its release schedule is not yet known.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Seyyede Zahra Mousavi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Nursing and Midwifery, in front of Shahid Rajaee Heart Hospital, intersection of Ayat Ah... Hashemi Rafsanjani Highway, Vali Asr Ave, Tehran,</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1996835119</zip>
        <telephone>+98 21 8865 5366</telephone>
        <email>szahra.mousavi@sbmu.ac.ir</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Seyyede Zahra Mousavi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Nursing and Midwifery, in front of Shahid Rajaee Heart Hospital, intersection of Ayat Ah... Hashemi Rafsanjani Highway, Vali Asr Ave, Tehran,</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1996835119</zip>
        <telephone>+98 21 8865 5366</telephone>
        <email>szahra.mousavi@sbmu.ac.ir</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>The mother to be primiparous.
Be in 18 to 35 age range.
Be literate in reading and writing.
Be a resident of Tehran.
Be Iranian.
Mother's Body Mass Index(BMI) be in 18.5 to 25 range in the beginning of pregnancy.
Gestational age be 37 to 42 full weeks.
Fetus be live singleton with cephalic presentation.
Neonatal weight be 2500 to 4000 gr.
Vaginal delivery with mediolateral episiotomy and without assisting tools(forceps, vacuum).
Be 1 and 2 grade episiotomy.
Do not consume cigarettes, alcohol or drugs.
The episiotomy incision site be repaired by chromic cut-coat thread.
free of any underlying disease that interferes with wound healing (chronic systemic, cardiopulmonary, connective tissue diseases, anemia, diabetes, malnutrition, hemophilia, mental disorders, and kidney failure) and obstetric problems such as diabetes in pregnancy, preeclampsia, eclampsia, coagulation disorders, Decollement, chorioamnionitis and immune system defects according to the person's statements and the medical/midwifery record.
She has not used any drugs effective on wound healing, such as corticosteroids, anticoagulants, antiepileptics, immunosuppressants, broad-spectrum antibiotics, and chemotherapy.
Rupture of membrane should not last more than 24 hours.
Do not have severe anemia during pregnancy (hemoglobin less than 7).
Disruption in the progress of labor and prolongation of the stages of labor (the duration of the first stage of labor more than 14 hours, the duration of the second stage more than 2 hours and the duration of the third stage more than half an hour) have not occurred.
There is no history of allergy to topical and herbal medicines according to the person's statement.
Don't have family conflicts and severe financial problems in the last 1 month.
Don't have any history or current illness of mental disorders such as depression according to the mother's statement.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>35 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>The person does not want to continue participating in the research.
On the designated days (the fifth day and the tenth day) after delivery, he has not returned for care.
Allergic to ostrich oil.
He has not used the oil regularly and for more than 2 times.
Having a hematoma at the episiotomy site in the first 24 hours after delivery.
Having fever and puerperal infection.
Having abnormal bleeding in the first 24 hours after delivery.
Having severe constipation after delivery and during the study.
Having hemorrhoids or anal fissure after childbirth.
The baby was hospitalized during the study.
Have sex in the first 10 days after giving birth.
If the samples need placenta curettage.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Ostrich oil will be prepared in 30 gram oil tubes containing ostrich oil to be used twice a day for two centimeters on the episiotomy suture for ten days after delivery. In this way, ostrich oil will be purchased from the pharmaceutical market and these tubes will be filled and autoclaved by the respected pharmaceutical consultant.</i_keyword>
      <i_keyword>Control group: Placebo oil contains an oil-based material (oserin) that is identical in shape, color, and consistency to the drug, in 30-gram oil tubes to be applied twice daily two centimeters across the episiotomy suture for ten days postpartum. will be prepared. Oserin oil will be purchased from the pharmaceutical market and these tubes will be filled and autoclaved by the respected pharmaceutical consultant.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Wound healing score. Timepoint: 1st, 5th and 10th day after delivery. Method of measurement: Perineal healing control form (REEDA).</prim_outcome>
      <prim_outcome>Maternal pain intensity score. Timepoint: 1st, 5th and 10th day after delivery. Method of measurement: Visual Analog Scale (VAS).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>-. Timepoint: -. Method of measurement: -.</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>2024-02-09</approval_date>
        <contact_name>Ethics committee of Shahid Beheshti University of Medical Sciences</contact_name>
        <contact_address>Valiasr Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
