<?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>IRCT201110153027N15</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2011-10-27</date_registration>
      <primary_sponsor>Tabriz University of Medical Sciences, Department Scholarships</primary_sponsor>
      <public_title>comparison of delivery outcomes between 2 methods of physiologic and traditional delivery</public_title>
      <acronym></acronym>
      <scientific_title>Title of proposal: comparison of delivery outcomes between 2 methods of physiologic and traditional delivery in women referred to norani shahid hospital in talesh in 2011-12</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2011-10-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size></target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/2997</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Other.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Delivery.</hc_freetext>
      <i_freetext>Intervention 1: Physiological childbirth:&#13;
  according to the Country Guideline, it’s a  method of natural childbirth, and Treatment approaches to alleviate include Non-medical Pain relievers: &#13;
Aromatherapy is a way in which You can rub lavender oil between your palms , and massage the  parturient woman’s waist and hips  during  all stages of labor ; she can use birth ball and there is no limitation during labor as well as she can freely choose any position ; serum and oxytocin  is not injected her in  routine way; oxytocin  injection is based on partograph. cardiac monitoring  is not continuously; Episiotomy can be performed immediately if needed(according to method in proposal).it is notable that if it is necessary , I will be trained by an expert instructor who helps me getting my Birth certificate. Intervention 2: Traditional childbirth: During the study, traditional childbirth is defined as : birth mother's hospitalization based on Obstetric Indications, continuous fetal heart rate monitoring(FHR), amniotomy is not performed (unless placental abruption is suspected), oxytocin should not be used (unless partograph-based intervention is necessary),using serum and branol, episiotomy was definded for women having their first pregnancy .it It should be noted that in traditional childbirth Everything is consistent with what is being done in the country.</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></firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address></address>
        <city></city>
        <country1></country1>
        <zip></zip>
        <telephone></telephone>
        <email></email>
        <affiliation></affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Fahimeh Shafaie</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Tabriz University of Medical Sciences, Central's No. 2, Research</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>347-51745</zip>
        <telephone>+98 41 1335 7314</telephone>
        <email>sehhatief@tbzmed.ac.ir</email>
        <affiliation>Tabriz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria&#13;
1-	Women aged between 18-35 years&#13;
2-	Gestational age 37-42 weeks based on the first day of the last menstrual period or based on ultrasound  in Gestational age prior to12 weeks.&#13;
3-	singleton pregnancy with cephalic presentation&#13;
4-	Having low-risk pregnancy (absence of chronic illness like heart disease, hypertension, lung disease, diabetes, anemia, urinary tract infection (UTI), thyroid disease, Epilepsy, no spontaneous abortion, Bleeding or any abnormal cases .&#13;
5-	 No specific or Unauthorized drug  is used during pregnancy&#13;
6-	primiparous pregnancy&#13;
7-	normal fetus-baby weigh less than 4000 grams by using Johnson's formula [W=( -N 155], Fundal height (cm) above the pubic symphysis minus 12 if Vertex above Ischial Spine or minus 11 if below Ischial Spines.&#13;
8-	no history of infertility&#13;
9-	normal pelvis diameters (based on vaginal examination),height  should not be under 145cm&#13;
10-	absence of mental illness or any other disorder that makes her unable to communicate(deafness – blindness)&#13;
11-	Interesting  to participate in  research study&#13;
&#13;
&#13;
Exclusion criteria&#13;
1-	maternal-fetal emergency intervention is required (Bleeding, like placental abruption, emergency cesarean for any reason) during labor&#13;
2-	withdraw from the partnership</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>35 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>O80</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>Physiological childbirth:&#13;
  according to the Country Guideline, it’s a  method of natural childbirth, and Treatment approaches to alleviate include Non-medical Pain relievers: &#13;
Aromatherapy is a way in which You can rub lavender oil between your palms , and massage the  parturient woman’s waist and hips  during  all stages of labor ; she can use birth ball and there is no limitation during labor as well as she can freely choose any position ; serum and oxytocin  is not injected her in  routine way; oxytocin  injection is based on partograph. cardiac monitoring  is not continuously; Episiotomy can be performed immediately if needed(according to method in proposal).it is notable that if it is necessary , I will be trained by an expert instructor who helps me getting my Birth certificate.</i_keyword>
      <i_keyword>Traditional childbirth: During the study, traditional childbirth is defined as : birth mother's hospitalization based on Obstetric Indications, continuous fetal heart rate monitoring(FHR), amniotomy is not performed (unless placental abruption is suspected), oxytocin should not be used (unless partograph-based intervention is necessary),using serum and branol, episiotomy was definded for women having their first pregnancy .it It should be noted that in traditional childbirth Everything is consistent with what is being done in the country.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Neonatal outcomes: Apgar scor. Timepoint: After intervention. Method of measurement: Cheklist/ examination/ observation.</prim_outcome>
      <prim_outcome>Neonatal outcomes:ABG. Timepoint: After intervention. Method of measurement: Cheklist/ examination/ observation.</prim_outcome>
      <prim_outcome>Neonatal outcomes: NICU. Timepoint: After intrevention. Method of measurement: Cheklist/ examination/ observation.</prim_outcome>
      <prim_outcome>Maternal outcomes: Post partum infection. Timepoint: After intervention. Method of measurement: Cheklist/ examination/ observation.</prim_outcome>
      <prim_outcome>Average lenghth of the second Stage of labor. Timepoint: Lenghth of intervention. Method of measurement: Partograph.</prim_outcome>
      <prim_outcome>Average lenghth of the third stage of labor. Timepoint: Lenghth of intervention. Method of measurement: Partograph.</prim_outcome>
      <prim_outcome>Maternal outcomes: Type of delivery. Timepoint: One month after intervention. Method of measurement: Cheklist/ examination/ observation.</prim_outcome>
      <prim_outcome>Average lenghth of the first stage of labor. Timepoint: Lenghth of intervention. Method of measurement: Partograph.</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>Tabriz University of Medical Sciences, Department Scholarships</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2011-10-11</approval_date>
        <contact_name>Tabriz University of Medical Sciences</contact_name>
        <contact_address>Tabriz University of Medical Sciences, 2 central Research Organization Tabriz  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
