<?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>IRCT20260808070572N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2026-08-14</date_registration>
      <primary_sponsor>Esfahan University of Medical Sciences</primary_sponsor>
      <public_title>The Effect of a Technology‑Based Childbirth Preparation Program on Childbirth Outcomes</public_title>
      <acronym></acronym>
      <scientific_title>Comparing the Effect of a Technology-Based Late-Pregnancy Childbirth Preparation Program on Childbirth Readiness, Fear of Childbirth, Childbirth Experience, and Mode of Delivery in Pregnant Women</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2026-09-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>70</target_size>
      <recruitment_status>Recruiting</recruitment_status>
      <url>https://irct.ir/trial/92351</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Random block randomization using RAS (Random Allocation Software) with blocks of sizes 4 and 6 and a 1:1 allocation ratio. The unit of randomization is the individual. The allocation sequence is generated by a person not involved in recruitment and placed in sequentially numbered opaque sealed envelopes (allocation concealment). Envelopes are opened in the order of participant enrollment.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: Childbirth Readiness. Condition 2: Fear of Childbirth. Condition 3: Childbirth Experience. Condition 4: Mode of Delivery.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Mothers in the intervention group receive a technology-based childbirth preparation program specifically designed for late pregnancy (from 36 weeks of gestation onward until the onset of labor). The program is delivered through an interactive online educational-supportive environment based on mothers’ preferences (extracted from the qualitative phase). It includes multimedia content (short 3- to 5-minute videos with downloadable Persian subtitles, audio podcasts, and infographics), self-care tools (smart calendar and reminders), a counseling system (text chat and discussion forum), and an intelligent chatbot that uses artificial intelligence to personalize the content and educational pathway according to each mother’s needs, preferences, and pregnancy status.The educational content covers physical exercises, breathing techniques, relaxation training, psychological support, and non-pharmacological methods for labor pain management. Eighty percent of the main content is made available within the first five days, with the remaining content provided gradually until the time of birth. The researcher also continuously offers online educational, supportive, and counseling support and reminds mothers to use the content via telephone calls and SMS. The aim of the intervention is to enhance childbirth preparedness and promote safe natural childbirth. Intervention 2: Control group: Receive routine pregnancy care according to the national protocol (including periodic prenatal visits at comprehensive health centers or clinics, physical examinations, routine laboratory tests, necessary ultrasounds, general prenatal education, and referral if needed). This group does not receive any additional technology-based educational-supportive intervention or childbirth preparation program.</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>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is No more information available.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Maryam Khalili</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 119, 1st Floor, Shahid Ali Akbari Alley, Modares Boulevard, Borujen, Chaharmahal and Bakhtiari Province, Iran</address>
        <city>Broujen</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8871853775</zip>
        <telephone>+98 38 3423 2020</telephone>
        <email>maryamkhalili68@yahoo.com</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Maryam Khalili</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 119, 1st Floor, Shahid Ali Akbari Alley, Modares Boulevard, Borujen, Chaharmahal and Bakhtiari Province, Iran</address>
        <city>Broujen</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8871853775</zip>
        <telephone>+98 38 3423 2020</telephone>
        <email>maryamkhalili68@yahoo.com</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Desire for Natural Vaginal Delivery
Pregnant women aged 20-49
Gestational age 36 weeks and 6 days and above
Iranian and resident of Isfahan
Consent to participate in the study
Single  pregnancy
Access to a smartphone, Internet, Desire to use it
No mental or chronic illnesses (heart disease, lung disease, etc.) based on information from the Sib system(Apple Integrated System)
Mental health screening (with the DASS questionnaire)
Use of the desired content and program for at least 5 days</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>49 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Presence of contraindications to normal (vaginal) delivery, as assessed by the attending physician
Severe hearing or visual impairment that prevents the use of the program’s audio and visual content
High-risk pregnancy (such as preeclampsia, placenta previa, active bleeding, etc.)</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
      <hc_code></hc_code>
      <hc_code></hc_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
      <hc_keyword></hc_keyword>
      <hc_keyword></hc_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Mothers in the intervention group receive a technology-based childbirth preparation program specifically designed for late pregnancy (from 36 weeks of gestation onward until the onset of labor). The program is delivered through an interactive online educational-supportive environment based on mothers’ preferences (extracted from the qualitative phase). It includes multimedia content (short 3- to 5-minute videos with downloadable Persian subtitles, audio podcasts, and infographics), self-care tools (smart calendar and reminders), a counseling system (text chat and discussion forum), and an intelligent chatbot that uses artificial intelligence to personalize the content and educational pathway according to each mother’s needs, preferences, and pregnancy status.The educational content covers physical exercises, breathing techniques, relaxation training, psychological support, and non-pharmacological methods for labor pain management. Eighty percent of the main content is made available within the first five days, with the remaining content provided gradually until the time of birth. The researcher also continuously offers online educational, supportive, and counseling support and reminds mothers to use the content via telephone calls and SMS. The aim of the intervention is to enhance childbirth preparedness and promote safe natural childbirth.</i_keyword>
      <i_keyword>Control group: Receive routine pregnancy care according to the national protocol (including periodic prenatal visits at comprehensive health centers or clinics, physical examinations, routine laboratory tests, necessary ultrasounds, general prenatal education, and referral if needed). This group does not receive any additional technology-based educational-supportive intervention or childbirth preparation program.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Fear of childbirth. Timepoint: Before the intervention and immediately after the intervention. Method of measurement: (Wijma Delivery Expectancy/Experience Questionnaire - WDEQ) A and B.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Childbirth Readiness. Timepoint: Before the intervention and immediately after the intervention. Method of measurement: Childbirth Readiness Scale.</sec_outcome>
      <sec_outcome>Childbirth Experience. Timepoint: Immediately after delivery. Method of measurement: Childbirth Experience Questionnaire (CEQ).</sec_outcome>
      <sec_outcome>Mode of delivery. Timepoint: Immediately after delivery. Method of measurement: By referring to the medical record.</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>Esfahan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2026-08-04</approval_date>
        <contact_name>Ethics committee of Isfahan University of Medical Sciences</contact_name>
        <contact_address>Secretariat of the Biomedical Research Ethics Committee Isfahan University of Medical Sciences Administrative Building No. 4, 2nd Floor Hezarjerib Street, University Campus, Isfahan, Iran Isfahan Isfehan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
