<?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>IRCT20200415047087N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-08-21</date_registration>
      <primary_sponsor>Jeeroft University of Medical Sciences</primary_sponsor>
      <public_title>Evaluation of the effect of prostration on pain and delivery time</public_title>
      <acronym></acronym>
      <scientific_title>The Effect of knee chest Decubitus - position on the length and duration of labor pain in nulliparous women   first- women referred to Ayatollah Kashani Hospital in Jiroft</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-08-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>40</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/49831</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Health service research, Other design features: Samples will be selected based on inclusion criteria and will be placed in two groups of control and intervention by simple random allocation method; In this way, first the goals of the project for pregnant women are stated and after obtaining written consent and ensuring the confidentiality of their patients' information, the samples will be placed in groups of two, the first person inside the bag containing balls A, B, C was D, select one of the balls and according to it, if ball A or C is taken out, it is in the intervention group and if ball B or D is taken out, it is placed in the control group, Randomization description: Samples will be placed in groups of two, the first person from the bag that contained balls A, B, C, D, select one of the balls and based on that if the ball A or C comes out in the group Intervention and if the ball B or D is taken out, it is in the control group. One of the advantages of simple randomization is that it is easy to use. In order to keep the number of people in the two groups the same, if people leave the study, the ball of the removed sample is put back in the bag so that the sample size does not decrease.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Duration of labor and pain intensity in nulliparous women.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: In addition to the usual care, in the intervention group, the prostration position will start at the beginning of the active phase in dilatation of 4 cm. Alternately (every hour, for 15 minutes) they will be in the prostration position until the end of complete cervical dilatation. Intervention 2: Control group: receive only routine care during labor.</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:
After completing the data collection and after analyzing the information related to the main variables of the study, they will be published in the form of a report on the end of the project and the article.

When:
After the article is published and as long as the article is online

To whom:
The data published in the form of an article will be accessible to anyone who searches for the article.

Conditions:
In order to increase the information in the field of midwifery care during labor and in the form of a printed article, the data will be usable

Where to obtain:
To the site of the journal where the article will be published

How to obtain:
Search databases and find a published article from this study

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Sareh Mehni</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Imam Reza Blvd., Sabzevaran Sq., Vice Chancellor for Education, Jiroft University of Medical Sciences</address>
        <city>Jiroft</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7861763730</zip>
        <telephone>+98 34 4331 4418</telephone>
        <email>sa.mehni@jmu.ac.ir</email>
        <affiliation>Jeeroft University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Sareh Mehni</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Imam Reza Boulevard, Sabzevaran Square, Vice Chancellor for Education, Jiroft University of Medical Sciences</address>
        <city>Jiroft</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7861763730</zip>
        <telephone>+98 34 4331 4418</telephone>
        <email>sa.mehni@jmu.ac.ir</email>
        <affiliation>Jeeroft University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Single pregnant women with fetal cephalic screening,
Term and low-risk pregnancies
No rupture of the bladder for more than 12 hours
Having spontaneous contractions and dilation of 4 cm of the cervix
Estimated fetal weight between 4000-2500 grams
Evidence of fetal health based on ultrasound findings
Not attending childbirth preparation classes
No known chronic diseases
No mental and anatomical disorders</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Exclude if you use painkillers or labor stimulants
Withdrawal from labor and natural childbirth such as decolonization, umbilical cord prolapse and fetal distress</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>Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: In addition to the usual care, in the intervention group, the prostration position will start at the beginning of the active phase in dilatation of 4 cm. Alternately (every hour, for 15 minutes) they will be in the prostration position until the end of complete cervical dilatation.</i_keyword>
      <i_keyword>Control group: receive only routine care during labor</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain intensity: The score that a person expresses according to the visual scale of pain, the intensity of her pain. Timepoint: Measure the severity of pain twice: before the intervention and after the intervention. Method of measurement: By asking the mother and using the visual pain scale.</prim_outcome>
      <prim_outcome>Duration of labor: Based on the standard partograph form in the women's file, the progress and duration of labor are determined. Timepoint: After the intervention. Method of measurement: Partograph form.</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>Jeeroft University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-02-04</approval_date>
        <contact_name>Ethics committee of jiroft University of Medical Sciences</contact_name>
        <contact_address>Imam Reza blv, Sabzevaran Square, Vice Chancellor for Education, Jiroft University of Medical Sciences Jiroft Kerman Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
