<?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>IRCT20231202060236N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2026-08-05</date_registration>
      <primary_sponsor>PNS HAFEEZ</primary_sponsor>
      <public_title>Influence of Rooming-in techniques and mode of delivery on early mother infant bonding</public_title>
      <acronym>MIB trial</acronym>
      <scientific_title>Influence of Rooming-in techniques and mode of delivery on early mother infant bonding</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2025-03-01</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>133</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/91556</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Other design features: improvement of practices, Blinding description: Blinding: Due to the nature of the study, complete blinding was not feasible. Participants (mothers) were aware of their mode of delivery and rooming-in status, and the healthcare providers (obstetricians, nurses, and midwives) responsible for routine maternal and neonatal care were also aware of these interventions as they were part of standard clinical management. The principal investigator supervised recruitment and data collection but did not influence clinical management or allocation to study groups. Data collectors administered the questionnaires using a standardized protocol without influencing participants' responses. Outcome assessment was based on the validated Postpartum Bonding Questionnaire (PBQ), which was completed by the mothers themselves, thereby minimizing assessor bias. During statistical analysis, datasets were coded and group identifiers were anonymized so that the statistician remained blinded to group allocation until completion of the primary analysis. A Data Safety and Monitoring Board was not constituted because this was a non-interventional observational study with no experimental intervention or safety concerns. Manuscript preparation and interpretation of results were performed after completion of the blinded statistical analysis using anonymized group codes.</study_design>
      <phase>3</phase>
      <hc_freetext>Condition 1: mother-infant bonding after delivery. Condition 2: mother infant bonding.</hc_freetext>
      <i_freetext>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>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 It is not yet known if there will be a plan to make this available</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Khalida Parveen</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>PNS HAFEEZ</address>
        <city>islamabad</city>
        <country1>Pakistan</country1>
        <zip>44000</zip>
        <telephone>+92 334 3288130</telephone>
        <email>khlaida83arain@gmail.com</email>
        <affiliation>PNS HAFEEZ</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Khalida Parveen</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>PNS HAFEEZ</address>
        <city>islamabad</city>
        <country1>Pakistan</country1>
        <zip>44000</zip>
        <telephone>+92 334 3288130</telephone>
        <email>khlaida83arain@gmail.com</email>
        <affiliation>PNS HAFEEZ</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Pakistan</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Primigravida aged 18 to 40 years,
full term pregnancy
ASA-II</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>40 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>multipara
patients with psychiatric disorders
patients with co-morbid conditions</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>mother, in</hc_code>
      <hc_code>mother, in</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>ICD-10</hc_keyword>
      <hc_keyword>mother infant bonding</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group:</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>PBQ score. Timepoint: after application of intervention. Method of measurement: questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Successful breast feeding. Timepoint: after intervention. Method of measurement: observation.</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>PNS HAFEEZ</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2025-01-01</approval_date>
        <contact_name>PNS HAFEEZ NAVAL HOSPITAL</contact_name>
        <contact_address>PNS HAFEEZ ISLAMABAD PUNJAB Pakistan</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
