<?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>IRCT20190415043283N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-12-07</date_registration>
      <primary_sponsor>Ahvaz University of Medical Sciences</primary_sponsor>
      <public_title>The implementation of birth plan and childbirth preparation classes plan on  maternal satisfaction and delivery outcomes</public_title>
      <acronym></acronym>
      <scientific_title>The effect of implementation of birth plan and childbirth preparation classes    maternal satisfaction and delivery outcomes: a randomized controlled clinical trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-12-05</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>300</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/52287</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Health service research, Randomization description: Pregnant mothers  participating in childbirth preparation classes will be randomly assigned into one of with the birth plan or with not birth plan (routine) using www.random.org, Blinding description: The outcome assessor will not know how the intervention and control groups are assigned and will review data on outcome variables without considering groups of individuals.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Vaginal delivery.</hc_freetext>
      <i_freetext>First, the topic of birth plan is integrated into the educational content of childbirth preparation classes.Then, the subjects participating in session 5 of the childbirth preparation classes write the birth plan and their childbirth will be scheduled base on their's birth plan..</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 data of this study will be accessible upon the request form the corresponding author after publication, or we may deposit our data in the “Figshare” for sharing with other researchers after the publication of the manuscript.

When:
The data will be accessible upon the request from the corresponding author or in the Figshare” after publication of the manuscript (we anticipate this time by the end of 2021)

To whom:
Our data will be accessible upon the request from faculty members who interested to use our data with the research purpose (with acknowledgement of authors in our study).

Conditions:
Interested researchers can send an e-mail to the corresponding author and request our data. In case of if we deposited our data in the “Figshare” cite, they will be accessible from the cite

Where to obtain:
Mojgan Javadnoori Ahvaz, Golestan Ave, Ahvaz Jundishapur University of Medical Sciences, Nursing &amp; Midwifery School, Midwifery Department

How to obtain:
The requested information will be sent at the most up to one week after receiving the email.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mojgan Javadnoori</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Golestan Ave</address>
        <city>Ahvaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>61357-15794</zip>
        <telephone>+98 61 3373 8331</telephone>
        <email>mojganjavadnoori@gmail.com</email>
        <affiliation>Ahvaz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mojgan Javadnoori</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Golestan Ave</address>
        <city>Ahvaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>61357-15794</zip>
        <telephone>+98 61 3373 8331</telephone>
        <email>mojganjavadnoori@gmail.com</email>
        <affiliation>Ahvaz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Singleton pregnancy
Low risk pregnancy without medical or medwifery history such as  history of abortion, infertility and preterm labour
Gestational age of 32–33 weeks
participation in 5 session of the childbirth preparation classes
Willingness to undergo vaginal delivery
Literacy (reading and writing in Persian)
Previous cesarean section with willingness to undergo vaginal delivery</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Reluctance to continue attending the study
Change of decision to C-section</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>Behavior</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>First, the topic of birth plan is integrated into the educational content of childbirth preparation classes.Then, the subjects participating in session 5 of the childbirth preparation classes write the birth plan and their childbirth will be scheduled base on their's birth plan.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Frequency of vaginal delivery. Timepoint: After delivery. Method of measurement: Maternal and neonatal outcomes checklist.</prim_outcome>
      <prim_outcome>Duration of labor stages. Timepoint: At the beginning of the active phase until one hour after postpartum. Method of measurement: Recorded time(minute).</prim_outcome>
      <prim_outcome>Frequency of labor induction. Timepoint: During labor. Method of measurement: Maternal  outcomes checklist.</prim_outcome>
      <prim_outcome>Maternal satisfaction with childbirth. Timepoint: 24 hours after postpartum. Method of measurement: McKay Questionnaire.</prim_outcome>
      <prim_outcome>Initiation of breastfeeding within 30 minutes after birth. Timepoint: After postpartum. Method of measurement: Neonatal outcomes checklist.</prim_outcome>
      <prim_outcome>Delivery fear scale. Timepoint: During labor. Method of measurement: Delivery fear scale.</prim_outcome>
      <prim_outcome>Frequency of fulfilling mother's  wishes. Timepoint: After postpartum. Method of measurement: Maternal outcomes checklist.</prim_outcome>
      <prim_outcome>Frequency of perineal lacerations. Timepoint: After postpartum. Method of measurement: Maternal outcomes checklist.</prim_outcome>
      <prim_outcome>Frequency of episiotomy. Timepoint: After postpartum. Method of measurement: Maternal outcomes checklist.</prim_outcome>
      <prim_outcome>Frequency of hospitalization in the neonatal intensive care NICU. Timepoint: After postpartum. Method of measurement: Neonatal outcomes checklist.</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>Ahvaz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-10-19</approval_date>
        <contact_name>Ethics Research Committee Ahvaz Jundishapur University of Medical Sciences</contact_name>
        <contact_address>Golestan Ave Ahvaz Khouzestan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
