<?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>IRCT2015112225051N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2017-08-27</date_registration>
      <primary_sponsor>Shahid Beheshti University of Medical Sciences</primary_sponsor>
      <public_title>The effect of using  admission protocol in labour on labour process, interventions and maternal and infant outcome</public_title>
      <acronym></acronym>
      <scientific_title>The effect of using admission protocol in normal childbirth on labour process, interventions and maternal  and infant outcome</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2015-12-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>200</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/21028</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Health service research.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Relationship between use of protocol of admission process in labor and labor process, interventions and maternal and infant outcom.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: A protocol for admission in labour will be used for the intervention group. The protocol consisted of the following key information for diagnosing of active phase: a.Existence regular uterine contractions (3-5 contractions in 10 minutes takes 40-60- seconds) b. Dilation of cervix ≥ 4 cm c. Existence of rupture of membrane, or bloody show. d. Women who did not have these signs will be returned to their home. Women will be given awareness regarding danger signs. They will contact the hospital in the case of any problem. e. If there is a long distance problem or mother has intense anxiety, women will be stayed in a special place in hospital which has been designed for this purpose. The emotional support will be given to them. Intervention 2: Control group:  The admission of this group of participant women in labour will be solely based on the clinical judgment of midwives or doctors.</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></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Freshteh Abasian kasegary</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahid Beheshti University of Medical Sciences, Velenjak St,  Shahid Chamran Highway</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1985717443</zip>
        <telephone>+98 21 2243 9888</telephone>
        <email>abasianfreshteh@gmail.com</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Farzaneh Pazandeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Nursing and Midwifery faculty of Shahid Behshti, Research Department, Valiasr Ave</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1985717443</zip>
        <telephone>+98 21 8865 5366</telephone>
        <email>pazandehz@gmail.com</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: low risk pregnant women without know medical condition; maternal age: 18-35 years old; first pregnancy; singleton pregnancy; gestational age 38-42 weeks; vertex presentation; regular fetal heart rate; normal BMI (25-19); normal implantation of placenta; no CPD; no history of surgical treatment on uterus; no substance abuse (tobacco, alcohol, heroin, glass); Newborns have no known medical conditions; no congenital abnormalities; no IUGR and macrosomia.&#13;
Exclusion criterion: Vaginal bleeding more than normal and temperature up to 37/8 °  in admission</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>35 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>080</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Single spontaneous delivery</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: A protocol for admission in labour will be used for the intervention group. The protocol consisted of the following key information for diagnosing of active phase: a.Existence regular uterine contractions (3-5 contractions in 10 minutes takes 40-60- seconds) b. Dilation of cervix ≥ 4 cm c. Existence of rupture of membrane, or bloody show. d. Women who did not have these signs will be returned to their home. Women will be given awareness regarding danger signs. They will contact the hospital in the case of any problem. e. If there is a long distance problem or mother has intense anxiety, women will be stayed in a special place in hospital which has been designed for this purpose. The emotional support will be given to them.</i_keyword>
      <i_keyword>Control group:  The admission of this group of participant women in labour will be solely based on the clinical judgment of midwives or doctors.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Method of birth. Timepoint: After of delivery. Method of measurement: Observation and record in check list.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Number of hospital visits. Timepoint: Site visits to admission. Method of measurement: Of enter to hospital to discharge or admission.</sec_outcome>
      <sec_outcome>Number of vaginal examinations. Timepoint: During first stage of normal labour. Method of measurement: Observation, record in check list.</sec_outcome>
      <sec_outcome>Use of continuous electronic fetal monitoring. Timepoint: During first stage of normal labor. Method of measurement: Observation, record in check list.</sec_outcome>
      <sec_outcome>Medication and analgesics used during labor. Timepoint: During first and second stage of normal labor. Method of measurement: Observation, record in check list.</sec_outcome>
      <sec_outcome>Use of fundal pressure. Timepoint: During second stage of normal labor. Method of measurement: Observation, record in check list.</sec_outcome>
      <sec_outcome>Length of  Postnatal Stay. Timepoint: During the fourth stage of labo. Method of measurement: Measurement by Digital chronometer, to record in check list.</sec_outcome>
      <sec_outcome>Perineal and vaginal tears. Timepoint: After of delivery. Method of measurement: Observation, clinical examination, record in check list.</sec_outcome>
      <sec_outcome>Unplanned out-of-Hospital Birth. Timepoint: After of delivery. Method of measurement: Observation, record in check list.</sec_outcome>
      <sec_outcome>Apgar score. Timepoint: 1 and 5 minute after of delivery. Method of measurement: Observation, record in check list.</sec_outcome>
      <sec_outcome>Newborn admission to NICU. Timepoint: After of delivery. Method of measurement: Observation, record in check list.</sec_outcome>
      <sec_outcome>Postpartum hemorrhage. Timepoint: After childbirth. Method of measurement: Measurement of HG and HCT level by blood sampling 24 h after childbirth.</sec_outcome>
      <sec_outcome>Mother’s satisfaction of childbirth. Timepoint: Before discharging of hospital. Method of measurement: Macky satisfaction questionnaire.</sec_outcome>
      <sec_outcome>Artificial rupture of membrane. Timepoint: In Latent phase before complete of dilatation. Method of measurement: Observation,  record in check list.</sec_outcome>
      <sec_outcome>Length of labour. Timepoint: admission time to delivery. Method of measurement: Measurement by Digital chronometer, to record in check list.</sec_outcome>
      <sec_outcome>Length of  first stage of labor. Timepoint: Since the onset of labor pains to full dilation of the cervix. Method of measurement: Clinical examination, Measurement by digital chronometer, record in check list.</sec_outcome>
      <sec_outcome>Length of second stage of labor. Timepoint: Complete dilatation to full embryo excretion. Method of measurement: Clinical examination,  Measurement by digital chronometer, record in check list.</sec_outcome>
      <sec_outcome>Length of the third stage of labor. Timepoint: full embryo excretion to full placenta excretion. Method of measurement: Observation, clinical examination, record in check list.</sec_outcome>
      <sec_outcome>Use of oxytocin during labor. Timepoint: During first and second stage. Method of measurement: Observation, record in 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>Shahid Beheshti University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2015-11-03</approval_date>
        <contact_name>Ethical commitee of Shahid Beheshti University of Medical Sciences</contact_name>
        <contact_address>Medical Sciences University of Shahid Beheshti Nursing and Midwifery faculty of Shahid Behshti, Vali Asr intersection prayer in front of the Rajai Hospital Beheshti Department of Nursing and Midwifery Tehran  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
