<?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>IRCT20231109060006N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2024-01-01</date_registration>
      <primary_sponsor>Shahroud University of Medical Sciences</primary_sponsor>
      <public_title>Investigating changes in part of the maternal care process compared to routine care</public_title>
      <acronym></acronym>
      <scientific_title>Investigating the effect of a maternal care virtual model based on a mobile phone application during pregnancy compared to in-person routine care</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2024-01-13</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>150</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/73701</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Health service research.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Prenatal care.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: pregnant mothers covered by a virtual model of care based on a mobile phone application. A group of mothers (75 people) will be cared for during pregnancy based on the above-designed model after obtaining written informed consent. Intervention 2: Control group: Pregnant mothers covered by in-person routine (usual) care. This group of pregnant mothers (75 people) will receive the same routine care during pregnancy after obtaining written informed consent and will only complete questionnaires.</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 written form of informed consent in two groups of mothers (intervention and control groups).
Standard psychometric questionnaire of satisfaction in pregnancy care.
The comparative pregnancy outcomes (like technical quality TQ, quality CQ, SQ, and satisfaction) in two groups of mothers (intervention and control groups).

When:
After finishing the doctoral course in the winter of 1403 (new year 2025)

To whom:
Researchers
Students

Conditions:
To complete your thesis and provide another aspect of virtual care.
The use of data can be published only with the permission of Shahroud University of Medical Sciences and the first supervisor.

Where to obtain:
Electronic Library of Shahroud University of Medical Sciences
​

How to obtain:
A written request must be given to the library, and after the approval of the first supervisor (Mrs. Dr. Karamet's office), access will be followed.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Hamideh Sabetrohani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Management Office, Shahroud University of Medical Sciences and Health Services, Hafte Tir Square, Shahroud, Iran. ​</address>
        <city>Shahroud</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۳۶۱۴۷-۷۳۹۴۳</zip>
        <telephone>+98 23 3239 5054</telephone>
        <email>hamidehsabetrohani@gmail.com</email>
        <affiliation>Shahroud University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Afsaneh Keramat</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Reproductive Health Department, Third-floor, Medical College, Shahroud University of Medical Sciences and Health Services, Hafte Tir Square, Shahroud, Iran. ​</address>
        <city>Shahroud</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۳۶۱۳۷۷۳۹۵۵</zip>
        <telephone>0098 21 02332395054</telephone>
        <email>keramat1@yahoo.com</email>
        <affiliation>Shahroud University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>The mother has a low-risk pregnancy.
She refers to comprehensive health service centers.
Her pregnancy should be planned and singleton.
The mother should have a guidance school education or higher.
The mother has the ability and skill to use a smart mobile phone (it does not mean ownership)</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>40 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>The mother has a high-risk pregnancy (including: a history of infertility, frequent miscarriage, heart disease, hypertension, diabetes, twin and multiple pregnancy, first trimester bleeding)​
Illiterate mother
The mother's lack of access to a smart phone</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>O36.7</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Maternal care for viable fetus in abdominal pregnancy</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: pregnant mothers covered by a virtual model of care based on a mobile phone application. A group of mothers (75 people) will be cared for during pregnancy based on the above-designed model after obtaining written informed consent.</i_keyword>
      <i_keyword>Control group: Pregnant mothers covered by in-person routine (usual) care. This group of pregnant mothers (75 people) will receive the same routine care during pregnancy after obtaining written informed consent and will only complete questionnaires.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>1- Technical quality includes: - the number of general care received, - the amount of mother and fetus weighing, - the number of self-care recorded by the mother, - the number of fetal heart sound checks, - the number of training Received from mothers on various topics (such as symptoms that require attention during pregnancy, nutrition and weight gain, personal hygiene, oral and dental hygiene, mental health, common complaints during pregnancy, breastfeeding), - the number and time of starting to receive medicinal supplements, - the number Attended childbirth preparation classes, - Frequency of performing and recording blood and urine test results, - Frequency of performing and recording ultrasound results. Timepoint: Once at the end of care number 5 of pregnancy (35-37 weeks). Method of measurement: Technical quality - using the maternal health care checklist registered in the electronic health record.</prim_outcome>
      <prim_outcome>2- Service quality includes: - choice of care provider, - communication and interaction, - having authority, - availability of support group, - continuity of care, - facilities and basic facilities, - preservation of dignity, - timeliness and immediate attention, - safety, - Prevention, - Access, and trust. Timepoint: Once at the end of care number 5 of pregnancy (35-37 weeks). Method of measurement: Service quality - using the questionnaire providing the CQMH model, which was prepared and approved by Tabrizi et al., the Persian version of this tool.</prim_outcome>
      <prim_outcome>3- Satisfaction in the following areas: - planning and scheduling, - technology (for virtual group), - provider, - privacy, - public. Timepoint: Once at the end of care number 5 of pregnancy (35-37 weeks). Method of measurement: Satisfaction - using the standard questionnaires presented in articles including (Pflugeisen 2017), this tool requires psychometrics for Iranian mothers.</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>Shahroud University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-02-07</approval_date>
        <contact_name>Ethics committee of Shahroud University of Medical Sciences.</contact_name>
        <contact_address>Research and Technology Vice-Chancellor, Faculty of Medicine, Shahrood University of Medical Sciences, Haftom Tir Square. Shahroud Semnan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
