<?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>IRCT20171111037380N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-09-11</date_registration>
      <primary_sponsor>Qazvin University of Medical Sciences</primary_sponsor>
      <public_title>Comparison of theAccompanying Midwife with Non-Obstetrician at Birth</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the Effect of Accompanying Midwife and Non-Midwife on the degree of Aanxiety and Labor Pain in Primipara Women</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-11-16</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>120</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/28003</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: The first-stage sampling method is available from among primiparous women who come to the hospital for delivery. In the second stage, randomly assigned blocks were divided into three intervention groups 1 and 2 and control group. To select the samples, the sealed envelopes used by the statistic consultant and the researcher and those who do the sampling do not know the contents of the envelopes, on the envelopes numbered from one to twenty six. At each sampling time, each sample picks up a number, which, after opening the envelope, is based on the contents of the envelope, the sample is in one of the intervention groups 1 and 2, or controlled.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: Anxiety. Condition 2: Labor Pain.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group 1: Intervention group 1 with Midwife. In this group, a Midwife who has completed a Physiological Delivery and is a member of the Midwifery Counseling and Counseling Center Provides Supportive Care from the Pregnant Mother. These behaviors include: Emotional Support [Encouraging the Mother to Make Statements such as the Nature of the Pain, the Effect of Pain intensity on the progress of Labor and the touch, and Maternal Massage, answers to Mothers' questions about the progress and Delivery success, Essential Education During Labor and Delivery (Breathing, Correct Positioning at different stages, ...), Physical Support (Help to Change Position, Accompaniment The Person has been in need of Moving and getting out of bed). This Midwife has no Involvement in Labor Control and Delivery. Intervention 2: Intervention group2: The intervention group 2 is associated with Non-Emergency. In this group, a Companion who has at least One Successful Natural Delivery has the choice of Mother at All Stages of Labor, Childbirth, and Postpartum Birth, and Emotional and Physical Supportive Behaviors such as Speaking and Encouraging, Moving, and Massage Back. Intervention 3: Control group: The Control group has No Companions and Routine Care is Provided by Doctors and Obstetricians.</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 total potential data can be shared after unidentifiable people

When:
Start the access period from 1398

To whom:
For researchers working in academic institutions, applied applications in medical universities

Conditions:
For scientific research and for use in hospitals

Where to obtain:
Qazvin University of Medical Sciences

How to obtain:
With reference to the scientific site of Qazvin University of Medical Sciences

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr. Zainat Jorabchi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Qazvin University of Medical Sciences</address>
        <city>Qazvin</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3419759811</zip>
        <telephone>+98 28 3333 6001</telephone>
        <email>zjourabchi@yahoo.com</email>
        <affiliation>Qazvin University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Zainat Jorabchi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Qazvin University of Medical Sciences</address>
        <city>Qazvin</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3419759811</zip>
        <telephone>+98 28 3333 6001</telephone>
        <email>zjourabchi@yahoo.com</email>
        <affiliation>Qazvin University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Iranian Native-Born Women
Sunnis 15-40 Years Old
The Pregnancy is between 37 Weeks and 42 Weeks
Have a Live Embryo, Monocular and without major Anomalies
Cephalic display and Normal weight 4000- 2500
Presence of Labor Contractions, Dilatation 3-4 cm, proper Pelvic Position</inclusion_criteria>
      <agemin>15 years</agemin>
      <agemax>40 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>- The Presence of Acute and Chronic Psychiatric Neuropsychiatric and Anxiety Recorded in the case and use of a Special Psychic disorder
- Having a History of Acute and Chronic Pain, such as Migraine and Appendix, etc. Recorded in the case
Having an Indication of Cesarean Section such as history of Surgery on the Uterus, Placenta Pervia, Head and Pelvic Misalignment, Preeclampsia, Cervicellacae Cervix, Fetal Distress and Partial ٍEarly Retirement
Use of Analgesic in the last 8 hours
- History of Blood Pressure, Gestational Diabetes and Other Underlying  Illnesses  Recorded in the case
- History of Alcohol Addiction, Smoking and Drug use
- Unwilling to Participate in Research</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>O99.3</hc_code>
      <hc_code>047.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Mental disorders and diseases of the nervous system complicating pregnancy, childbirth and the puerperium</hc_keyword>
      <hc_keyword>-Complications of labour and delivery</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Behavior</i_code>
      <i_code>Behavior</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group 1: Intervention group 1 with Midwife. In this group, a Midwife who has completed a Physiological Delivery and is a member of the Midwifery Counseling and Counseling Center Provides Supportive Care from the Pregnant Mother. These behaviors include: Emotional Support [Encouraging the Mother to Make Statements such as the Nature of the Pain, the Effect of Pain intensity on the progress of Labor and the touch, and Maternal Massage, answers to Mothers' questions about the progress and Delivery success, Essential Education During Labor and Delivery (Breathing, Correct Positioning at different stages, ...), Physical Support (Help to Change Position, Accompaniment The Person has been in need of Moving and getting out of bed). This Midwife has no Involvement in Labor Control and Delivery.</i_keyword>
      <i_keyword>Intervention group2: The intervention group 2 is associated with Non-Emergency. In this group, a Companion who has at least One Successful Natural Delivery has the choice of Mother at All Stages of Labor, Childbirth, and Postpartum Birth, and Emotional and Physical Supportive Behaviors such as Speaking and Encouraging, Moving, and Massage Back.</i_keyword>
      <i_keyword>Control group: The Control group has No Companions and Routine Care is Provided by Doctors and Obstetricians.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Improve Satisfaction. Timepoint: At the end of the Intervention. Method of measurement: Checklist.</prim_outcome>
      <prim_outcome>Duration of the Active Phase First and Second Stages of Labor. Timepoint: From the onset of the Active Phase (3-4 cent) to Baby Delivery. Method of measurement: Partograph.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Anxiety. Timepoint: Before Entering the Study, After Entering the Study in Dilatation 3-4, 8-10 and Postpartum. Method of measurement: Spilberger's Explicit and Secret Anxiety Questionnaire.</sec_outcome>
      <sec_outcome>Labuor Pain. Timepoint: Before Entering the Study, After Entering the Study in 3-4 centuries Dilatation, 5-7 cm and the Second Stage of Labor. Method of measurement: Visual Analogue Scale.</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>Qazvin University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-10-25</approval_date>
        <contact_name>Ethics Committee in Biomedical Research of Qazvin University of Medical Sciences</contact_name>
        <contact_address>Qazvin University of Medical Sciences،  Bahonar Blvd Qazvin Qazvin Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
