<?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>IRCT20200721048154N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-08-24</date_registration>
      <primary_sponsor>Ahvaz University of Medical Sciences</primary_sponsor>
      <public_title>The effect of lubricating vaginal with natural animal fat on the second stage of labor, frequency of episiotomy and preineal laceration in primiparous women</public_title>
      <acronym></acronym>
      <scientific_title>The effect of lubricating vaginal with natural animal fat on the second stage of labor, frequency of episiotomy and preineal laceration in primiparous women</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-03-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>129</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/49761</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Simple randomization method and using a table of random numbers in such a way that in case of unit number 1-2-3 samples in the control group, 4-5-6 samples in the intervention group 1 (gel), 7-8-9 samples in the group Intervention 2 (oil), Blinding description: Participants after admission to the hospital and having all the inclusion criteria after completing the informed consent form are completely randomly placed in one of the control groups, intervention 1 (gel), intervention 2 (oil) and participants are unaware of the allocation of study.</study_design>
      <phase>3</phase>
      <hc_freetext>Duration of the second stage of labor and birth canal injuries.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group 1 (gel): The intervention in the intervention group will be performed during labor after dilation is complete. During the second stage of labor, after wearing sterile gloves by the midwife, gently massage with two index and middle fingers impregnated with lubricant gel purchased from Razak Laboratories in the amount of 5 ml from one wall to another wall of the vagina (in the form of movement and Return (letter U) will be done by gently pushing the rectum up and down so that each part lasts at least a minute. The massage will continue during and between pushing the mother. Intervention 2: Group 2 Intervention (oil): The intervention in the intervention group will be performed during labor after dilatation is complete. During the second stage of labor, after wearing sterile gloves by a midwife, gently massage with two index and middle fingers dipped in duck tallow oil, from one wall to another wall of the vagina (in the form of a reciprocating motion, the letter U in English) with pressure. Gently move up and down the rectum so that each part lasts at least a minute. The massage will continue during and between pushing the mother. The intervention group will be given a perineal massage with tallow for 5-10 minutes. Intervention 3: Control group: The control group will receive non-drug massage and routine care during hospitalization.</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 There is no more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mona Matori Abdollahi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No.415/6,Nine Bahar street, Abadan</address>
        <city>Ahwaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6315733653</zip>
        <telephone>+98 61 5332 9401</telephone>
        <email>Mona.2017.sh00@gmail.com</email>
        <affiliation>Ahvaz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>dr.Mojgan Javadnoori</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Golestan</address>
        <city>Ahvaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6315733653</zip>
        <telephone>+98 61 5332 9401</telephone>
        <email>Javadnoori-m@ajums.ac.ir</email>
        <affiliation>Ahvaz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age 18-35 years
single and primiparous pregnancy
Gestational age 37-42 weeks according to ultrasound of the first 3 months of pregnancy or last menstrual period
Cephalic presentation
Perineal length 5-3 cm</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>35 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Occurrence of any obstetric complication including high fever, prolonged rupture of the membranes,placental abruption, decreased FHR, vaginal bleeding, and complications that endanger the health of the mother or her baby.
participated delivery.
Posterior occipital position.
Contraindications to natural vaginal delivery and episiotomy.
Vaginal infections and genital herpes and chronic disease in the mother.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>O94</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>sequelae of complication of pregnancy childbirth and the puerperium</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 1 (gel): The intervention in the intervention group will be performed during labor after dilation is complete. During the second stage of labor, after wearing sterile gloves by the midwife, gently massage with two index and middle fingers impregnated with lubricant gel purchased from Razak Laboratories in the amount of 5 ml from one wall to another wall of the vagina (in the form of movement and Return (letter U) will be done by gently pushing the rectum up and down so that each part lasts at least a minute. The massage will continue during and between pushing the mother.</i_keyword>
      <i_keyword>Group 2 Intervention (oil): The intervention in the intervention group will be performed during labor after dilatation is complete. During the second stage of labor, after wearing sterile gloves by a midwife, gently massage with two index and middle fingers dipped in duck tallow oil, from one wall to another wall of the vagina (in the form of a reciprocating motion, the letter U in English) with pressure. Gently move up and down the rectum so that each part lasts at least a minute. The massage will continue during and between pushing the mother. The intervention group will be given a perineal massage with tallow for 5-10 minutes.</i_keyword>
      <i_keyword>Control group: The control group will receive non-drug massage and routine care during hospitalization.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Time of The second stage of labor. Timepoint: The second phase of labor. Method of measurement: The length of the second stage of labor will be measured through a researcher-made questionnaire.</prim_outcome>
      <prim_outcome>Episiotomy. Timepoint: The fourth stage of labor. Method of measurement: recorded through a researcher-made questionnaire during delivery.</prim_outcome>
      <prim_outcome>Perineal laceration. Timepoint: The fourth stage of labor. Method of measurement: recorded through a researcher-made questionnaire during delivery.</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>Ahvaz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-06-29</approval_date>
        <contact_name>Ethics Committee of Ahwaz Jundishapur University of Medical Sciences</contact_name>
        <contact_address>No.415/6, Nine Bahar street, Abadan Abadan Khouzestan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
