<?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>IRCT20260712070138N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2026-09-17</date_registration>
      <primary_sponsor>Bagheiat-allah University of Medical Sciences</primary_sponsor>
      <public_title>Investigating the effect of education based on needs assessment of pregnant mothers on infant health indicators and unplanned hospitalization of mother and infant up to six weeks after delivery</public_title>
      <acronym></acronym>
      <scientific_title>Investigating the effect of education based on needs assessment of pregnant mothers on infant health indicators and unplanned hospitalization of mother and infant up to six weeks after delivery</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2026-10-12</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>186</target_size>
      <recruitment_status>Recruiting</recruitment_status>
      <url>https://irct.ir/trial/91878</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Other, Purpose: Education/Guidance, Randomization description: A random number table will be designed using Random Allocation Software.
Write the group assignment on cards and place in opaque, sealed, numbered envelopes - the envelopes will be prepared by someone other than the principal investigator (e.g., a midwifery education expert).
After the mother enters the study, the next envelope will be opened and her group will be determined.</study_design>
      <phase>2-3</phase>
      <hc_freetext>Pregnancy.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: In addition to regular group and individual care, participants in this group will receive four monthly sessions of pregnancy, childbirth preparation, breastfeeding, and newborn care education. They will also be provided with a booklet and contact number for potential questions, and weekly educational text messages (short text with key points) will be sent. A counseling hotline will be provided to answer mothers' questions. Intervention 2: Control group: Participants in this group receive only routine health center care (periodic checkups, general education) - they do not receive any additional intervention from the researcher.</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>Vajihe Biniaz</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>18 Mofateh St., Vahid 5, Health Education Clinic, Imam Hossein Hospital</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9155966736</zip>
        <telephone>+98 915 883 1467</telephone>
        <email>v.biniaz@gmail.com</email>
        <affiliation>Bagheiat-allah University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Vajihe Biniaz</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>18 Mofateh St., Vahid 5, Health Education Clinic, Imam Hossein Hospital</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9155966736</zip>
        <telephone>+98 915 883 1467</telephone>
        <email>v.biniaz@gmail.com</email>
        <affiliation>Bagheiat-allah University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Educability (mental health)
Pregnancy age greater than 24 and less than 34 weeks
Maternal age 18 to 45 years
No uncontrolled chronic diseases such as diabetes, blood pressure, and heart disease that affect neonatal outcomes
Having written approval from a gynecologist to participate in the class</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>40 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Delivery before 36 weeks (to control for the confounding effect of prematurity).
Unwillingness to continue cooperation at any stage of the study
Infants born weighing 2500 g or less
Infants with major congenital anomalies requiring prolonged hospitalization
Occurrence of pregnancy complications such as preeclampsia, gestational diabetes, or placenta previa that require special care and independently affect outcomes.
Attendance at less than 75% of the educational sessions (in the test group).
Stillbirth or death of the infant before the end of the follow-up period.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Z34</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: In addition to regular group and individual care, participants in this group will receive four monthly sessions of pregnancy, childbirth preparation, breastfeeding, and newborn care education. They will also be provided with a booklet and contact number for potential questions, and weekly educational text messages (short text with key points) will be sent. A counseling hotline will be provided to answer mothers' questions.</i_keyword>
      <i_keyword>Control group: Participants in this group receive only routine health center care (periodic checkups, general education) - they do not receive any additional intervention from the researcher.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Needs-based training. Timepoint: Before the intervention begins. Method of measurement: Training Needs Assessment Checklist.</prim_outcome>
      <prim_outcome>Baby's weight at birth. Timepoint: The baby's first weight immediately after birth. Method of measurement: The first recorded weight of the baby immediately after birth in grams.</prim_outcome>
      <prim_outcome>Complications of the neonatal period. Timepoint: Any health disorder in the first 28 days of life that requires diagnostic or therapeutic intervention. Method of measurement: Diagnoses recorded in the file include jaundice requiring hospitalization and phototherapy, hypoglycemia, sepsis, seizures, hospitalization in the neonatal intensive care unit, pneumonia, diarrhea.</prim_outcome>
      <prim_outcome>Unplanned hospitalization of the mother. Timepoint: Unexpected admission to hospital due to postpartum complications and early discharge up to 6 weeks postpartum. Method of measurement: Recording cases of infant readmissions with a doctor's diagnosis, through records and telephone calls.</prim_outcome>
      <prim_outcome>Unplanned hospitalization of a newborn. Timepoint: Any readmission of the infant after initial discharge from the hospital due to medical problems up to six weeks of age. Method of measurement: Recording of newborn readmissions by physician diagnosis, via telephone call and file.</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>Bagheiat-allah University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2026-06-29</approval_date>
        <contact_name>Ethics Committee of Baqiyatallah University of Medical Sciences</contact_name>
        <contact_address>18 Mofateh St., Vahid 5, Health Education Clinic, Imam Hossein Hospital Imam Hossein hospital health clinic Mashhad Razavi Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
