<?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>IRCT20231008059654N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-11-01</date_registration>
      <primary_sponsor>Ahvaz University of Medical Sciences</primary_sponsor>
      <public_title>Design, implementation and evaluation of a psychosocial intervention in women with recurrent miscarriage: a multi-method mixed study</public_title>
      <acronym></acronym>
      <scientific_title>Design, implementation and evaluation of a psychosocial intervention in women with recurrent miscarriage: a multi-method mixed study</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-10-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>92</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/73123</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Women with frequent miscarriages who are hospitalized in hospitals in Ahvaz will be randomly divided into intervention and control groups. Sampling will be done easily. After the initial selection of the samples, the allocation in the intervention and control groups will be random with a ratio of 1:1 in blocks of 4 and 6. In order to hide the allocation, opaque sealed envelopes that are numbered in order and the type of intervention is written inside them will be used. These envelopes will be prepared by the researcher not involved in data collection. The envelopes will be opened after completing the pre- test and at the same moment of assigning people to the groups, and the first envelope will be given to the first person who meets the study entry criteria and will continue until the desired sample size is completed, Blinding description: The statistical analysis of the data and the evaluation of the results are done using SPSS software by the professor of statistics and without the knowledge of the intervention and control groups.</study_design>
      <phase>N/A</phase>
      <hc_freetext>psychosocial intervention in women with recurrent miscarriage.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group:In the intervention group, content has been prepared for women with frequent abortion experience, which will probably include the implementation of a training program for midwives and.... during the hospitalization of women in the hospital (psycho-social support measures) and after discharge when visiting the centers Health care will be provided through a trained health team. Intervention 2: Control group: In the control group, only routine supportive care will be provided by health team members working in health centers.</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is There is no further information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Afsanehtalebi68@gmail.com</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>5th floor, Baharan Building, 21 Golestan St., third dead end, Golestan Square, Azimieh, Karaj, Alborz Province</address>
        <city>Karaj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3155768877</zip>
        <telephone>+98 26 3340 1207</telephone>
        <email>Afsanehtalebi68@gmail.com</email>
        <affiliation>Ahvaz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Afsaneh Talebi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>5th floor, Baharan Building, 21 Golestan St., third dead end, Golestan Square, Azimieh, Karaj, Alborz Province</address>
        <city>Karaj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3155768877</zip>
        <telephone>+98 26 3340 1207</telephone>
        <email>Afsanehtalebi68@gmail.com</email>
        <affiliation>Ahvaz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Ability to understand and speak Persian
Absence of any physical and mental illness
Obtaining a score above 12 based on the Edinburgh Depression Questionnaire
Getting a score above 30 based on the Spielberger Anxiety Questionnaire
No smoking
Recurrent spontaneous abortion as two or three (or more) consecutive abortions
The fetus is healthy and single
Age 20-45 years
Childless or having any number of children before the missed pregnancies
Last abortion within the last 1 to 6 months
Willingness to participate in research
The ability to provide rich and sufficient information on the subject being studied</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>45 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>occurrence of stressful events such as death of relatives, divorce, etc.
pregnancy
Severe depression and anxiety</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>N96</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Recurrent pregnancy loss</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:In the intervention group, content has been prepared for women with frequent abortion experience, which will probably include the implementation of a training program for midwives and.... during the hospitalization of women in the hospital (psycho-social support measures) and after discharge when visiting the centers Health care will be provided through a trained health team.</i_keyword>
      <i_keyword>Control group: In the control group, only routine supportive care will be provided by health team members working in health centers.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Perceived psycho-social support score. Timepoint: before the start of the intervention and 4 weeks after the start of the intervention. Method of measurement: psychosocial support questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Anxiety score. Timepoint: before the start of the intervention and 4 weeks after the start of the intervention. Method of measurement: Spielberger anxiety questionnaire.</sec_outcome>
      <sec_outcome>Depression score. Timepoint: before the start of the intervention and 4 weeks after the start of the intervention. Method of measurement: Edinburgh depression questionnaire.</sec_outcome>
      <sec_outcome>Stress score. Timepoint: before the start of the intervention and 4 weeks after the start of the intervention. Method of measurement: perceived stress questionnaire.</sec_outcome>
      <sec_outcome>Quality of life score. Timepoint: before the start of the intervention and 4 weeks after the start of the intervention. Method of measurement: 36-question quality of life questionnaire.</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>Ahvaz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-10-07</approval_date>
        <contact_name>research ethics committees of Ahvaz Jundishapur University of Medical Sciences</contact_name>
        <contact_address>5th floor, Baharan Building, 21 Golestan St., third dead end, Golestan Square, Azimieh, Alborz Ahvaz Khouzestan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
