<?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>IRCT20210315050718N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-04-25</date_registration>
      <primary_sponsor>Tehran University of Medical Sciences</primary_sponsor>
      <public_title>The effect of e-learning  pregnancy care training for husbands on self-care and perceived stress in nulliparous pregnant women</public_title>
      <acronym></acronym>
      <scientific_title>The effect of e-learning  pregnancy care training for husbands on self-care and perceived stress in nulliparous pregnant women</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-03-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>68</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/55056</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Other design features: In this study, education is given to the wives of pregnant women and the health consequences of the wives of their nulliparous women are measured to show the extent to which training, support and empowerment of the wives of nulliparous pregnant women can affect the health of their pregnant women, Randomization description: 68 samples are selected by available sampling method and list of apple system of each center and are allocated in two groups of control and intervention using block random allocation method. Due to the sample size, 17 blocks of 4 are required for random block allocation. The intervention group will be displayed with A and the control group with B. Pregnant women 's husbands are placed in quadruple blocks with two AAs each for intervention and two BBs for control. Samples can be placed in blocks in 6 different ways as follows:
1-AABB 2-ABAB 3-ABBA 4-BABA 5-BBAA 6-BAAB Then we roll the dice, for example 4 comes, BABA rolls the dice again, for example 5 comes BBAA and ... we repeat so much and We roll the dice to complete 68 samples or use the website https://www.Randomization.com to determine the random sequence of blocks. In order to hide the random allocation from the researcher, a dark envelope sample size is prepared and each of the random sequences created is recorded on a card and placed inside the envelope, and finally the envelope lid is pasted. At the beginning of the registration of individuals, according to the order of arrival of the samples, one of the envelopes is opened in order and the assigned group of that sample is specified, Blinding description: Participants: People in the control group also receive routine care at the health center, so they also receive training, and it is not the case that they do not receive any training, and in the intervention group, we teach them.
Thus, participants do not know which group (intervention or control) they are in.
Data Analyzer: Also does not know if this is the data of the intervention group or the control group that is analyzing its data.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Perceived stress in nulliparous pregnant women, self-care in nulliparous pregnant women, weight gain in nulliparous pregnant women.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Wives of nulliparous pregnant women who receive prenatal care training electronically. Intervention 2: Control group: Wives of nulliparous pregnant women receiving routine prenatal care training.</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:
Only part of the data, such as information about its main and secondary consequences, can be shared.

When:
Start of access period one year after printing results

To whom:
It will be available to researchers working in academic and scientific institutions, and people in industry can also apply for it.

Conditions:
Properly documented and referenced to the study

Where to obtain:
fariba.abbaszadehnezamabad.09331277418، fariba.abbaszadehnezamabad2017@gmail.com

How to obtain:
The applicant must fully state the purpose of the study and how to cite and use the material. This request will be sent to the tutor. If the tutor approves, the study data will be provided to the person. This process lasts for 10 days and at the end, the applicant will be asked to Cite it correctly

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Fariba.Abbaszadehnezamabad</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 5, Unit 2, Jahangir Khani Alley, Sina Town, Khalij St., Fatah Highway, Fatah Highway, Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1378635469</zip>
        <telephone>+98 21 6625 1327</telephone>
        <email>fariba.abbaszadehnezamabad2017@gmail.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Fariba Abbaszadehnezamabad</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 5, Unit 2, Jahangir Khani Alley, Sina Town, Khalij St., Fatah Highway, Fatah Highway, Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1378635469</zip>
        <telephone>+98 21 6625 1327</telephone>
        <email>fariba.abbaszadehnezamabad2017@gmail.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria for nulliparous pregnant women:                                                                                       Age between 18-45 years (reproductive ages)                                                                                                        Have a minimum gestational age of 8 weeks (based on the first ultrasound performed or the first day of the last menstrual period)                                                                                                                       First pregnancy                                                                                                                                                                                                                              Single pregnancy                                                                                                                                                                                                                                 Living with a spouse                                                                                                                                                                                                                                 Inclusion criteria for wives of nulliparous women:                                                                                                                                                                             Monogamy                                                                                                                                                                                                                                                                                                                                                                                         Smartphone access</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>45 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Criteria for not including nulliparous pregnant women:                                                                    Inability to read and write                                                                                             unwanted pregnancy                                                                                                                                                                        Having a history of infertility                                                                                                                                                                   Dissatisfaction with participating in the study                                                                                                          Having symptoms threatening abortion (spotting, not hearing the sound of the fetal heart, back pain, etc.)                                                                                                                              Having a mental illness according to the individual's own expression                                                                                                                                                                                                                            Having a specific disease such as diabetes and ...                                                                                           Criteria for not including the wives of nulliparous women:                                                                                             Inability to read and write                                                                                                                                                                 Dissatisfaction with participating in the study                                                                                                       Having a mental illness according to the individual's own expression                                                                                                                                                                                                                Lack of ability to use social networks</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>N/A</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Wives of nulliparous pregnant women who receive prenatal care training electronically</i_keyword>
      <i_keyword>Control group: Wives of nulliparous pregnant women receiving routine prenatal care training</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Self-care score. Timepoint: At the beginning of the study (before the intervention), 8 weeks after the intervention. Method of measurement: Momeni Pregnant Women Self-Care Questionnaire.</prim_outcome>
      <prim_outcome>Perceived stress score. Timepoint: At the beginning of the study (before the intervention), 8 weeks after the intervention. Method of measurement: Cohen Perceived Stress Questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Weight gain of pregnant women (the closer the weight gain in the apple system is to the balance line, the more desirable). Timepoint: At the beginning of the study (before the intervention), 8 weeks after the intervention. Method of measurement: Calibrated with digital scales and comparing the weight of pregnant women with the optimal weighting line of pregnant women in the apple system.</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>Tehran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-02-20</approval_date>
        <contact_name>Ethics Committee in Research, School of Nursing and Midwifery, Rehabilitation, Tehran University of </contact_name>
        <contact_address>Tohid Square, Dr. Mirkhani St. (Eastern Nusrat) Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
