<?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>IRCT20160424027557N9</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-12-20</date_registration>
      <primary_sponsor>Karaj University of Medical Sciences</primary_sponsor>
      <public_title>Effect of Tele continuous Care on Postpartum Adaptation and Neonate Perception</public_title>
      <acronym></acronym>
      <scientific_title>Effect of Tele continuous Care on Postpartum Adaptation and Neonate Perception among Primiparous women</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-02-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>48</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/67371</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: The block sampling was used for random allocation using Excel software to form the groups. Samples are divided into intervention and control groups by quadruple random blocks. There are six possibilities for blocking (BAAB, ABAB, AABB, ABBA, BBAA, BABA). First, one of the blocks is selected and four of the participants in that block will be selected. As a result, the number A belongs to the intervention group and the number B belongs to the control group.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Continuous postpartum follow up.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Primiparous Iranian women aged &gt;18 giving birth to a single healthy full-term newborn. After the first visit at the postpartum department of the chosen hospital and providing the health tips and breastfeeding consultation to the new mothers and obtaining the consent form and completing the demographic questionnaire, the intervention group will undergo a six week follow up via phone calls and messaging apps in order to provide the relevant health educations such as Neonatal Screening programs, postnatal examinations in health centers, diagnosing   the warning signs in mother or baby and providing the individual consultations involving lactating and feeding problems, baby care, complement use, taking care of the stump, baby sleep tips, safely bathing and massaging the baby, telling helpful tips to relieve colic pains, emphasizing on husband support, sexual health and family  planning consultations, scoring the postpartum depression scale and responding to the questions and health concerns of the mother and so on. In the second and sixth weeks post delivery, the postpartum adaptation and neonatal perception questionnaires will be asked from participants. Intervention 2: Control group: Primiparous Iranian women aged &gt;18 giving birth to a single healthy full-term newborn. After the first visit at the postpartum department of the chosen hospital and providing the health tips and breastfeeding consultation to the new mothers and obtaining the consent form and completing the demographic questionnaire, the control group will only benefits from the routine separate postnatal visits in health centers. In the second and sixth weeks post delivery, the postpartum adaptation and neonatal perception questionnaires will be asked from participants.</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:
All collected variables

When:
From 2023

To whom:
It will be available only for people working in academic institutions

Conditions:
No criterion

Where to obtain:
By Email: Dr.akbarikamrani@abzums.ac.ir and Dr. Mahnaz Akbari Kamrani would be responsive

How to obtain:
By Email

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Fateme Arank</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No7, Shirood Alley, Shahed Blvd, Tehranpars, Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1654815371</zip>
        <telephone>+98 21 7670 4709</telephone>
        <email>arangfateme@gmail.com</email>
        <affiliation>Alborz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Mahnaz Akbari Kamrani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Medicine Faculty, Nabovat Square, Booali Blvd</address>
        <city>Karaj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3149969415</zip>
        <telephone>+98 26 3428 7339</telephone>
        <email>Dr.akbarikamrani@abzums.ac.ir</email>
        <affiliation>Alborz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Primiparous women
Iranian nationality and proficiency in Persian language
Ability to use cell phones and messaging apps
Being married
Age over 18 years old
Delivering single birth
Birth of a healthy and full term baby
Absence of known medical or mental disease according to self statement
Not being addicted and not having the history of  opioids, amphetamines and alcohol use
Signing the informed voluntary consent form</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Occurring any serious medical complications in mother or neonate during the study
Obtaining a 15 or higher depression score from the Edinburgh Postpartum Depression Questionnaire</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>Z39.2</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Encounter for routine postpartum follow-up</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Lifestyle</i_code>
      <i_code>Lifestyle</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Primiparous Iranian women aged &gt;18 giving birth to a single healthy full-term newborn. After the first visit at the postpartum department of the chosen hospital and providing the health tips and breastfeeding consultation to the new mothers and obtaining the consent form and completing the demographic questionnaire, the intervention group will undergo a six week follow up via phone calls and messaging apps in order to provide the relevant health educations such as Neonatal Screening programs, postnatal examinations in health centers, diagnosing   the warning signs in mother or baby and providing the individual consultations involving lactating and feeding problems, baby care, complement use, taking care of the stump, baby sleep tips, safely bathing and massaging the baby, telling helpful tips to relieve colic pains, emphasizing on husband support, sexual health and family  planning consultations, scoring the postpartum depression scale and responding to the questions and health concerns of the mother and so on. In the second and sixth weeks post delivery, the postpartum adaptation and neonatal perception questionnaires will be asked from participants.</i_keyword>
      <i_keyword>Control group: Primiparous Iranian women aged &gt;18 giving birth to a single healthy full-term newborn. After the first visit at the postpartum department of the chosen hospital and providing the health tips and breastfeeding consultation to the new mothers and obtaining the consent form and completing the demographic questionnaire, the control group will only benefits from the routine separate postnatal visits in health centers. In the second and sixth weeks post delivery, the postpartum adaptation and neonatal perception questionnaires will be asked from participants.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Postpartum adaptation score. Timepoint: Assessment the postpartum adaptation score within the second and sixth weeks after delivery. Method of measurement: Barkin Index of Maternal Functioning.</prim_outcome>
      <prim_outcome>Neonate perception score. Timepoint: Assessment the neonate perception score within the second and sixth weeks postpartum. Method of measurement: The Newborn Perception Scale Broussard and Hanter 1971.</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>Alborz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-12-03</approval_date>
        <contact_name>Reaearch Ethics comittees of Alborz University of Medical Science</contact_name>
        <contact_address>Research Ethics Committees of Alborz University of Medical SiencesTaleghani square, north Taleghani boulvard, Karaj, Alborz Medical University Karaj Alborz Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
