<?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>IRCT2015102624712N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2015-12-11</date_registration>
      <primary_sponsor>Vice chancellor for Research, School of Nursing and Midwifery, Iran University of Medical Scienc</primary_sponsor>
      <public_title>The effect of combination of Chamomile and Calendula oficinalis on Episiotomy wound healing and pain in nulliparous women</public_title>
      <acronym></acronym>
      <scientific_title>The effect of combination of Chamomile and Calendula oficinalis on Episiotomy wound healing and pain in nulliparous women</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2015-12-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>99</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/20802</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive.</study_design>
      <phase>2</phase>
      <hc_freetext>wound healing of episiotomy , pain of episiotomy.</hc_freetext>
      <i_freetext>Intervention 1: The intervention group: Combined ointment 3 times a day(each 8 hours) for 10 days as much as one finger (equivalent to about 20 mlligrams) to be applied topically on the site of episiotomy. Intervention 2: The placebo group: Placebo ointment 3 times a day(each 8 hours) for 10 days as much as one finger (equivalent to about 20 mlligrams) to be applied topically on the site of episiotomy. Intervention 3: Control group follow the routine of the hospital.</i_freetext>
      <results_actual_enrolment></results_actual_enrolment>
      <results_date_completed></results_date_completed>
      <results_url_link></results_url_link>
      <results_summary> Investigating the Effect of Chamomile-Marigold Combination Ointment on Episiotomy Wound Recovery in Nulliparous Women &lt;br /&gt;&#13;
Abstract&lt;br /&gt;&#13;
Aim: Episiotomy, which was first presented in 1920, is one of the most common obstetrics interventions proposed as a way to prevent injuries to pelvic floor and the head of the fetus during labor. Marigold, with the scientific name of Calendula Officinalis, has pharmacological and therapeutic effects, such as wound healing, anti-inflammatory, antibacterial, immune stimulation, anti-tumor, anti-AIDS, and etc. chamomile is also one of those plants which are anti-inflammatory, antibacterial, and antioxidant. Therefore, the present study was done to investigate the effect of chamomile-marigold combination ointment on episiotomy wound recovery in nulliparous women.&lt;br /&gt;&#13;
Methods:The present randomized clinical study was conducted on 99 women who met the inclusion criteria in Shahid Akbar Abadi hospital from January 2015 to June 2016. The samples were divided in three groups of chamomile-marigold combination ointment, placebo, and control using random number table. Then, samples were collected 4 hours after labor and episiotomy wounds were started to get cured using 20mg of prescribed ointment, the equivalent of a knuckle, for 8 hours during 10 days. REEDA instrument was used to measure the degree of episiotomy sound recovery 1, 5, and 10 days after labor. Data analysis was performed through SPSS statistical software, Version 20, Fisher exact tests, analysis of variance, Chi-square, and non-parametric tests of Kruskal-Wallis, median, and Friedman. Less than 0.05 P value was considered significant.&lt;br /&gt;&#13;
Findings:Based on variance analysis, three under study groups did not have statistically significant difference in terms of sound healing prior to intervention (p=0.964); however, comparison of wound healing scores 1, 5, and 10 days after intervention showed statistically significant difference among three groups. (P&lt; 0.001)&lt;br /&gt;&#13;
Conclusion:Due to healing, anti-inflammatory, and antibacterial properties, chamomile-marigold combination ointment increases episiotomy wound recovery significantly and it can be recommended for nulliparous women which are afflicted with mentioned injury.&lt;br /&gt;&#13;
Keyword: Episiotomy, Chamomile, Marigold, Wound Recovery &lt;br /&gt;&#13;
    </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>Bahare Davami</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Next to the Mottahari hospital, Rashid Yasmi street, Valiasr avenue, Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>00</telephone>
        <email>ba.davami@gmail.com</email>
        <affiliation>School of Nursing and Midwifery, Iran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Homa Sadeghi Aval Shahr</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Next to the Mottahari hospital, Rashid yasmi street, Valiasr avenue, Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>00</telephone>
        <email>sadeghi.ho.46@iums.ac.ir</email>
        <affiliation>School of Nursing and Midwifery, Iran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: being primiparous women with age range 18-35 years; gestational age 37-42 weeks; single pregnancy; cephalic presentation;ability to read and write; living with his wife's; insensitivity to special herbal drugs in past; non-smoking and no drug dependence; no history of disease impaired wound healing; Lack PROM more than 18 hours; absence of reconstructive surgery on the vagina and perineum; No rectocel, cystocele severe (grade 2 or higher), wall or mass in the vagina; mediolateral episiotomy without rupture and spread with same amount of Lidocaine; lack of volvo and vaginal inflammation at the beginning of research; body mass index less than 30;. Exclusion criteria: there interfere with the progress of labor; prolonged second stage of labor longer than 2 hours; extend the length of the incision or there tear except episiotomy tear; abnormal vaginal bleeding; shoulder dystocia (leading to the maneuvers other than Robert Mack); manual removal of placenta; hematoma; having intercourse to the end of the study (10 days postpartum); curettage procedure the first 24 hours after birth; not use the ointment on a regular; puerperal fever; an infection of episiotomy; need to re-stitch the episiotomy.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>35 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria></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>Placebo</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>The intervention group: Combined ointment 3 times a day(each 8 hours) for 10 days as much as one finger (equivalent to about 20 mlligrams) to be applied topically on the site of episiotomy</i_keyword>
      <i_keyword>The placebo group: Placebo ointment 3 times a day(each 8 hours) for 10 days as much as one finger (equivalent to about 20 mlligrams) to be applied topically on the site of episiotomy.</i_keyword>
      <i_keyword>Control group follow the routine of the hospital</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Episiotomy wound healing. Timepoint: 4 hours after delivery, 1 days after delivery, 5 days after delivery ,and 10 days after delivery. Method of measurement: REEDA Scale of wound healing.</prim_outcome>
      <prim_outcome>Pain in episiotomy. Timepoint: 4 hours after delivery, 1 days after delivery, 5 days after delivery ,and 10 days after delivery. Method of measurement: Visual analog scale.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Sedative tablets counting. Timepoint: Tenth 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>Vice chancellor for Research, School of Nursing and Midwifery, Iran University of Medical Scienc</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2015-11-11</approval_date>
        <contact_name>Ethics committee Vice chancellor for Research Iran University of Medical Sciences</contact_name>
        <contact_address>Hemmat freeway (beside Milad Tower), Tehran Tehran  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
