<?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>IRCT20120718010324N50</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-06-28</date_registration>
      <primary_sponsor>Tabriz University of Medical Sciences</primary_sponsor>
      <public_title>The effect of supportive interventions on birth experience</public_title>
      <acronym></acronym>
      <scientific_title>The effect of supportive interventions on birth experience: Randomized Controlled Trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-08-02</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/38227</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Randomization will be conducted using the website www.random.org and through blocking with block sizes of four and six and an allocation ratio of 1: 1 to the two groups of intervention and control.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Birth experience.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: The intervention group will receive interventions during labor, delivery, and postpartum. Interventions during labor and delivery include the provision of latent and active labor definitions, duration of labor, answering questions from women, respectful care, caring with empathy, management of labor pain (use of pharmacological pain relief methods such as remifentanil or pethidine or non-pharmacological such as teaching visualization techniques, breathing techniques, progressive muscle relaxation, massage or use a warm bag according to the woman's preference), providing a hygienic room, private, presence of doula, the possibility of telephone conversation with her family, woman's participation in decision-making, not doing unnecessary interventions such as connecting the bladder catheter, frequent vaginal examinations, pushing during delivery, women's inactivity, lack of nutrition,  continuous heartbeat auscultation and recording cardiotocography, use of early onset of oxytocin, perineal/pubic shaving, privacy and confidentiality (using a separate room, no vaginal examination in the presence of women or other providers, the absence of a male student, access to a suitable cover for keeping hijab during transfer to other parts of the hospital), getting different positions such as upright position during labor, doing exercise during labour, encouraging the woman to follow their own urge to push, no routine use of episiotomy, choosing the delivery position according to the woman choice, delayed umbilical cord clamping, controlled cord traction, no nasal or oral suction baby in case of clear amniotic fluid, and during postpartum included use of uterotonics for the prevention of postpartum haemorrhage, sufficient analgesia during episiotomy repair, skin to skin contact during the first hour after birth, breastfeeding during the first hour after birth, uterine tonus assessment, regular assessment of vaginal bleeding, uterine contraction, fundal height, temperature and heart rate during the first 24 hours starting from the first hour after birth, no antibiotics prophylaxis for uncomplicated vaginal birth and follow up and responding to postpartum maternity problems by telephone and, if necessary, attending in person will be provided. Intervention 2: The control group will receive routine maternity care.</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is Participants' data is confidential.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Solmaz Ghanbari Homayi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Nursing &amp; Midwifery, South Shariati street</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5155884818</zip>
        <telephone>+98 41365706391</telephone>
        <email>homayisolmaz@gmail.com</email>
        <affiliation>Tabriz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mojgan Mirghafourvand</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Nursing &amp; Midwifery Faculty, South Shariati Street</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5138947977</zip>
        <telephone>+98 41 3479 6770</telephone>
        <email>mirg1385@yahoo.com</email>
        <affiliation>Tabriz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age older than 18 years
Gestational age of 37 to 42 weeks</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Having complications during pregnancy or childbirth such as preeclampsia, diabetes, placenta abruption
Having a cesarean section indication such as history of cesarean section and ...
Having mental-psychological problems, according to mother's report</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>Z39.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Encounter for care and examination of mother immediately after delivery</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Behavior</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: The intervention group will receive interventions during labor, delivery, and postpartum. Interventions during labor and delivery include the provision of latent and active labor definitions, duration of labor, answering questions from women, respectful care, caring with empathy, management of labor pain (use of pharmacological pain relief methods such as remifentanil or pethidine or non-pharmacological such as teaching visualization techniques, breathing techniques, progressive muscle relaxation, massage or use a warm bag according to the woman's preference), providing a hygienic room, private, presence of doula, the possibility of telephone conversation with her family, woman's participation in decision-making, not doing unnecessary interventions such as connecting the bladder catheter, frequent vaginal examinations, pushing during delivery, women's inactivity, lack of nutrition,  continuous heartbeat auscultation and recording cardiotocography, use of early onset of oxytocin, perineal/pubic shaving, privacy and confidentiality (using a separate room, no vaginal examination in the presence of women or other providers, the absence of a male student, access to a suitable cover for keeping hijab during transfer to other parts of the hospital), getting different positions such as upright position during labor, doing exercise during labour, encouraging the woman to follow their own urge to push, no routine use of episiotomy, choosing the delivery position according to the woman choice, delayed umbilical cord clamping, controlled cord traction, no nasal or oral suction baby in case of clear amniotic fluid, and during postpartum included use of uterotonics for the prevention of postpartum haemorrhage, sufficient analgesia during episiotomy repair, skin to skin contact during the first hour after birth, breastfeeding during the first hour after birth, uterine tonus assessment, regular assessment of vaginal bleeding, uterine contraction, fundal height, temperature and heart rate during the first 24 hours starting from the first hour after birth, no antibiotics prophylaxis for uncomplicated vaginal birth and follow up and responding to postpartum maternity problems by telephone and, if necessary, attending in person will be provided.</i_keyword>
      <i_keyword>The control group will receive routine maternity care.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Birth experience. Timepoint: Four weeks postpartum. Method of measurement: Childbirth Experience Questionnaire version 2.0.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Duration of childbirth stages. Timepoint: During the labor and childbirth stages. Method of measurement: Partograph.</sec_outcome>
      <sec_outcome>Frequency of oxytocin use. Timepoint: After childbirth. Method of measurement: Postpartum checklist.</sec_outcome>
      <sec_outcome>Frequency of Cesarean childbirth. Timepoint: After childbirth. Method of measurement: Postpartum checklist.</sec_outcome>
      <sec_outcome>Apgar score. Timepoint: 5 minutes and 10 minutes after baby's birth. Method of measurement: Postpartum checklist.</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>Tabriz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-12-03</approval_date>
        <contact_name>Ethics committee of Tabriz University of Medical Sciences</contact_name>
        <contact_address>Research department, third floor, central construction number 2, Tabriz University of Medical Sciences, Golgasht Street, Azadi Avenue, Tabriz, East Azerbaijan Tabriz East Azarbaijan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
