<?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>IRCT2015111725002N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2016-01-12</date_registration>
      <primary_sponsor>Vice Chancellor for Research ,Hormozgan University of Medical Sciences.Mother &amp; Child Welfare resear</primary_sponsor>
      <public_title>The impact of water birth on childbirth</public_title>
      <acronym></acronym>
      <scientific_title>Effect of water immersion during the first stage of labor on pain and the outcome of labor of primipara women attending to Khaleej-e- fars hospital in Bandar Abbas</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2015-11-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>200</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/20988</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive.</study_design>
      <phase>2</phase>
      <hc_freetext>Labor pain.</hc_freetext>
      <i_freetext>Intervention 1: In the intervention group, mother in the active phase of labor will enter into the tub full of water with the appropriate temperature in order to investigate the effects of immersion in water on the duration and intensity of labor. Labor pain intensity will evaluate by using the VAS before entering the water and then every hour until exiting from water. Mother will remain in water all of the first stage of labor. The duration of first stage of labor will calculate in minutes from 4 cm cervical dilatation to fully cervical dilatation.Mother will have no restrictions on eating and drinking. Finally, the results will be compared with the control group. Intervention 2: In the control group: routine care, labor control will perform and will not use any method of pain reduction during labor. Mother will have no limitation on choice of positions during labor. Labor pain intensity will evaluate by using the VAS every hour until full dilatation of cervix. The duration of first stage of labor will calculate in minutes from 4 cm cervical dilatation to fully cervical dilatation. Mother will have no restrictions on eating and drinking. Finally, the results will be compared with the intervention group.</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>Fatemeh Dabiri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Nursing &amp; Midwifery collage,Resalat Ave,</address>
        <city>Bandar Abbas</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 76 3366 6367</telephone>
        <email>fatemehdabiri@sbmu.ac.ir; fateme.dabiri@hums.ac.ir; fateme.dabiri @gmail.com</email>
        <affiliation>Hormozgan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Fatemeh Dabiri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Nursing &amp; midwifery collage,Resalat Avenue</address>
        <city>Bandar Abbas</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 76 3366 6367</telephone>
        <email>fatemehdabiri@sbmu.ac.ir; fateme.dabiri@hums.ac.ir; fateme.dabiri@gmail.com</email>
        <affiliation>Hormozgan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: &#13;
Nulliparous women; Age 35-18 years;Height over 150 cm; BMI 18.5-24.9; Singleton pregnancy; Gestational age 37-40;  Participation in preparation for childbirth classes; Vertex presentation; Alive fetus; Not having risk factors (abnormal vital signs of mother- of mother underlying disease- prolonged rupture of membrane- vaginal bleeding, oligo or polyhydramnios- placenta previa-  placental abruption-  meconium-stained- intrauterine growth restriction- fetal macrosomia- abnormal fetus- History of infertility); Regular uterine contractions; &#13;
4 cm cervical dilatation; Normal NST;Mother's consent to participate in research. &#13;
&#13;
 Exclusion criteria:&#13;
 Abnormal fetal heart rate changes; abnormal changes in vital signs of mother; Abnormal vaginal bleeding during labor;  meconium passage by fetus during labor; requirement to  any medical intervention for pregnant of mother during labor; unwillingness to continue to participate in research</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>Spontaneous vertex delivery</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>In the intervention group, mother in the active phase of labor will enter into the tub full of water with the appropriate temperature in order to investigate the effects of immersion in water on the duration and intensity of labor. Labor pain intensity will evaluate by using the VAS before entering the water and then every hour until exiting from water. Mother will remain in water all of the first stage of labor. The duration of first stage of labor will calculate in minutes from 4 cm cervical dilatation to fully cervical dilatation.Mother will have no restrictions on eating and drinking. Finally, the results will be compared with the control group.</i_keyword>
      <i_keyword>In the control group: routine care, labor control will perform and will not use any method of pain reduction during labor. Mother will have no limitation on choice of positions during labor. Labor pain intensity will evaluate by using the VAS every hour until full dilatation of cervix. The duration of first stage of labor will calculate in minutes from 4 cm cervical dilatation to fully cervical dilatation. Mother will have no restrictions on eating and drinking. Finally, the results will be compared with the intervention group.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Labor pain intensity. Timepoint: before intervention then every hour until get out of water. Method of measurement: Visual Analog Scale.</prim_outcome>
      <prim_outcome>The duration first stage of labor. Timepoint: The time from 4 cm cervical dilatation to complete dilation of the cervix. Method of measurement: Time in Minutes.</prim_outcome>
      <prim_outcome>The length of second stage of labor. Timepoint: The time between full dilatation of cervix and fetal expulsion. Method of measurement: Time in minute.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Perineum status. Timepoint: after delivery. Method of measurement: Intact/episiotomy/laceration.</sec_outcome>
      <sec_outcome>Apgar Score. Timepoint: 1 and 5 minutes after birth. Method of measurement: numeric.</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>Vice Chancellor for Research ,Hormozgan University of Medical Sciences.Mother &amp; Child Welfare resear</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2015-11-18</approval_date>
        <contact_name>Ethics Committee of Hormozgan University of Medical Sciences</contact_name>
        <contact_address>Hormozgan University of Medical Sciences,Shahid Chamran BLV. Bandar Abbas, Iran Bandar Abbas  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
