<?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>IRCT20181214041963N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-02-03</date_registration>
      <primary_sponsor>Ahvaz University of Medical Sciences</primary_sponsor>
      <public_title>Design, Implementation and Evaluation of a plan for Labor and Normal Delivery</public_title>
      <acronym></acronym>
      <scientific_title>Design, Implementation and Evaluation of a plan for Labor and Normal Delivery Based on Evidence-Based Clinical Practice: A mixed methods evaluation design</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-04-04</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>256</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/68372</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Sampling will be done by the available method.
  In this way, since the beginning of the study, all mothers who meet the entry criteria and do not meet the exit criteria have been selected as samples, and this work will continue until the final sample size is reached.
  allocation to random groups:
Research units will be assigned to intervention and control groups using random block method (six blocks).
In this way, first 6 possible states of blocks (AABB, ABAB, BBAA, BABA, ABBA, BAAB) are listed and a number from one to six will be assigned to each block.
  Then a number between one and six is randomly selected using the random number table, and then people are selected based on the block corresponding to the number.
will be assigned to the intervention (A) and control (B) groups.
  This work will continue until the sample volume is completed, Blinding description: The statistical analyst is unaware of the type of intervention and control groups.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Design, Implementation and Evaluation of a plan for Labor and Normal Delivery.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: In the intervention group of the Department of Labor and Natural Birth, it will be performed by trained midwives based on the evidence-based designed program. Intervention 2: Control group: In the control group, the Department of Labor and Natural Delivery will be performed according to the routine care of the hospital by providers other than trained people.</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:
The reviewed data can be shared without mentioning the names of people

When:
The access period starts 6 months after the results are published

To whom:
Policymakers, researchers in academic and scientific institutions

Conditions:
If you have an official letter from the scientific center

Where to obtain:
Request from the printed magazine and indexed sites, request via e-mail of the project manager

How to obtain:
6 months after completing the study of the application, the data will be sent to the project manager, if the conditions are met, up to two months.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>mina iravani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Golestan Boulevard</address>
        <city>Ahvaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>15794 - 61357</zip>
        <telephone>+98 61 3311 0000</telephone>
        <email>minairavani2004@gmail.com</email>
        <affiliation>Ahvaz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>mina iravani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Golestan Boulevard</address>
        <city>Ahvaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>15794 - 61357</zip>
        <telephone>+98 61 3311 0000</telephone>
        <email>minairavani2004@gmail.com</email>
        <affiliation>Ahvaz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Consent to participate in the study
primiparous women
singleton pregnancy
live fetus
maternal age 15-49 years
gestational age 37 to 42 weeks (based on the first day of the last menstrual period or first trimester ultrasound)
cephalic presentation
normal fetal heart rate (110 -160)</inclusion_criteria>
      <agemin>15 years</agemin>
      <agemax>49 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>history of any incision on the uterus
- detection of abnormal dimensions of the pelvis through vaginal examination and examination of ischial spines, obstetric conjugation, sacrum concavity, condition of pelvic wall(s) and pubic arch angle
abnormal bleeding
epidural anesthesia
presence of any abnormalities in soft tissue or Bony birth canal (diagnosed through vaginal examination)
having an abnormal fetus or intrauterine growth restriction
indication for cesarean section (fetal distress, prolapse of the umbilical cord, diagnosis of absolute pelvic stenosis by the doctor)
known medical diseases based on the patient's file including history or current suffering from any systemic disease such as diabetes, high blood pressure, heart disease, kidney disease, nervous disease, liver disease, digestive disease, respiratory disease, thyroid disease)
Fetal membranes that have been ruptured for more than 8 hours
High-risk pregnancy (preeclampsia, placenta previa, Placental abruption, chorioamnionitis, placenta accreta)</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>N/A</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: In the intervention group of the Department of Labor and Natural Birth, it will be performed by trained midwives based on the evidence-based designed program.</i_keyword>
      <i_keyword>Control group: In the control group, the Department of Labor and Natural Delivery will be performed according to the routine care of the hospital by providers other than trained people.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Type of delivery. Timepoint: after the study. Method of measurement: Questionnaire.</prim_outcome>
      <prim_outcome>Satisfaction with childbirth. Timepoint: after the study. Method of measurement: Mackey questionnaire.</prim_outcome>
      <prim_outcome>Childbirth Experience. Timepoint: after the study. Method of measurement: Childbirth Experience  Questionnaire.</prim_outcome>
      <prim_outcome>The pain of childbirth. Timepoint: During the study. Method of measurement: Visual Analogue Scale.</prim_outcome>
      <prim_outcome>The length of labor stages. Timepoint: During the study. Method of measurement: Check list.</prim_outcome>
      <prim_outcome>Apgar first and fifth minutes. Timepoint: After the intervention. Method of measurement: check list.</prim_outcome>
      <prim_outcome>Hospitalization in the neonatal intensive care unit. Timepoint: After the intervention. Method of measurement: check list.</prim_outcome>
      <prim_outcome>Postpartum bleeding. Timepoint: During the study. Method of measurement: check list.</prim_outcome>
      <prim_outcome>Genital lacerations. Timepoint: During the study. Method of measurement: check list.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Early breastfeeding. Timepoint: During the study. Method of measurement: check list.</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>2023-01-28</approval_date>
        <contact_name>Research Ethics Committees of Ahvaz Jundishapur University of Medical Sciences</contact_name>
        <contact_address>Golestan Ahvaz Khouzestan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
