<?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>IRCT20190308042971N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-08-24</date_registration>
      <primary_sponsor>Gonabad University of Medical Sciences</primary_sponsor>
      <public_title>The effect of Rosemary cream on pain intensity and wound healing of episiotomy</public_title>
      <acronym></acronym>
      <scientific_title>The effect of Rosemary cream on pain intensity and wound healing of episiotomy in nulliparous women</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-07-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>92</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/40092</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Other, Purpose: Treatment, Randomization description: To randomly assign samples to each of the two intervention and control groups, four variable blocks are used. In this way, six of the possible blocks (BBAA, BABA, ABBA, BAAB AABB, ABAB) are first listed, and each one is assigned a number from one to six. Then, randomly, a number is selected from one to six, followed by individuals assigned to the test group (A) and control (B), based on the corresponding block. This will continue until the sample size is completed, Blinding description: In order to blindness, the drugs prepared with codes A and B were prepared by the pharmacist's assistant, and only themselves knew about their content, the researcher and consultant of statistics and patients did not know the type  of cream.</study_design>
      <phase>3</phase>
      <hc_freetext>episiotomy.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group:  Rosemary Cream 30 grams twice a day for 10 days (prepared at the Pharmacological Research Center of Mashhad Medicinal Plants) will be applied to the amount of a fingertip locally on the episiotomy site. Intervention 2: Control group: Placebo cream 30 grams twice a day for 10 days (prepared at the Pharmacological Research Center of Mashhad Medicinal Plants) will be applied to the amount of a fingertip locally on the episiotomy site.</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:
Only part of the data such as information about the main outcome or the like can be shared.

When:
6 months after printing the results

To whom:
Medical researchers

Conditions:
Available at the reasonable request of researchers.

Where to obtain:
Corresponding author of the published article

How to obtain:
Send email to the Corresponding  author

Comments:
----------</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Fatemeh Hadizadeh Talasaz</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Asian Roadside , Gonabad University of Medical Sciences</address>
        <city>Gonabad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۹۶۹۱۷۹۳۷۱۸</zip>
        <telephone>+98 517223028</telephone>
        <email>shahnazhadizadeh@yahoo.com</email>
        <affiliation>Gonabad University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Fatemeh Hadizadeh Talasaz</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Asian Roadside , Gonabad University of Medical Sciences</address>
        <city>Gonabad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۹۶۹۱۷۹۳۷۱۸</zip>
        <telephone>+98 517223028</telephone>
        <email>shahnazhadizadeh@yahoo.com</email>
        <affiliation>Gonabad University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria:Completion of informed consent form
Gestational age Between 37-42 weeks
The age of the mother Between 18-35 years old
Single baby
Cephalic
Natural vaginal delivery and Middle lateral episiotomy
Baby weight between 2500-4000 grams
Iranian-Resident of Marvdasht city and The villages around it
Minimum fifth grade primary education
Mother in active phase of labor (dilatation 3-4 cm and regular uterine contractions)و
BMI is 18/5-24/9 kg / m2
Mother lives  with hers husband
nulliparous</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>35 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>indication for cesarean section(Distress fetal, umbilical cord prolapse, diagnosis of the Tight pelvis by the doctor)
having midwifery problems at admission(placenta previa،Polyhydramnios، Oligo Hydramnios)
amniotic membrane rupture for more than 12 hours
clear symptoms of perineal and vaginal infection at the time of admission
anemia  or thrombocytopenia
having diabetes, anemia,Immune system disorders,...
use effective medication for wound healing(Glucocorticoids, anticoagulants, immunosuppressants, chemotherapy, alcohol and benzodiazepines)
use of drugs and tobacco
anal lesions, Perineum or history of  surgery on Perineum and cystocel and severe rectus</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>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group:  Rosemary Cream 30 grams twice a day for 10 days (prepared at the Pharmacological Research Center of Mashhad Medicinal Plants) will be applied to the amount of a fingertip locally on the episiotomy site</i_keyword>
      <i_keyword>Control group: Placebo cream 30 grams twice a day for 10 days (prepared at the Pharmacological Research Center of Mashhad Medicinal Plants) will be applied to the amount of a fingertip locally on the episiotomy site</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Wound healing of episiotomy. Timepoint: 1-4-10 days after childbirth. Method of measurement: Perineal Improvement Assessment Scale (REEDA).</prim_outcome>
      <prim_outcome>Pain intensity. Timepoint: 1-4-10 days after childbirth. Method of measurement: Visual Analogue Scale.</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>Gonabad University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-12-03</approval_date>
        <contact_name>Research Ethics Committee of Gonabad University of Medical Sciences</contact_name>
        <contact_address>Asian Roadside،Gonabad University of Medical Sciences Gonabad Razavi Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
