<?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>IRCT20241101063556N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2024-12-30</date_registration>
      <primary_sponsor>Shahroud University of Medical Sciences</primary_sponsor>
      <public_title>The impact of midwife empowerment in promoting childbearing motivation among women with one child</public_title>
      <acronym></acronym>
      <scientific_title>The impact of midwife empowerment based on the REDI model in promoting childbearing motivation among women with one child</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2025-01-04</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>120</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/80337</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: In this multicenter randomized controlled trial (RCT), eligible women from Hazrat Raqiyeh, Bahar, and Tadbir centers in Semnan will be enrolled sequentially upon providing informed consent and will be randomly assigned to either the intervention or control group.

Randomization method: A block randomization method with a block size of four will be used to allocate eligible women to the intervention or control groups.
Unit of randomization: The individual participant.
Randomization tool: A randomization sequence will be generated using the website https://www.sealedenvelope.com/simple-randomiser/v1/lists for a sample size of 120, with a block size of four in two groups.

Sequence generation: The generated randomization sequence will be provided to the central site. To conceal allocation, group assignments will be placed in sealed, numbered envelopes. After midwives at the participating centers contact the central site,  researcher will sequentially open envelopes for eligible participants and allocate them to the corresponding group.</study_design>
      <phase>N/A</phase>
      <hc_freetext>childbearing.</hc_freetext>
      <i_freetext>Intervention 1: All midwives and health caregivers from the healthcare centers of Hazrat Rouhollah, Bahar, and Tadbir in Semnan are invited to participate in training classes aimed at empowering midwives. The educational content of these classes is based on in-depth qualitative interviews and a systematic review derived from the results of a doctoral thesis with the code IR.SHMU.REC.1401.153. The training will be conducted in the form of a two-day workshop totaling 12 hours.                                        Workshop Topics: Day 1:Communication skillsCounseling skills in pre-pregnancy services Childbearing counseling.                                             Day 2:Infertility counselingPersuasion against abortionConsequences of having a single childTrained midwives, after completing the educational courses, will seek eligible women for study participation and obtain consent to assign them to either the intervention or control group. Those placed in the intervention group will receive face-to-face childbearing counseling sessions lasting 20 minutes, once a week for four weeks. Intervention 2: Control Group: Eligible women at health centers will be invited to receive routine counseling until the required sample size is reached, and fertility intention will also be assessed in this 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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
After anonymizing the individuals' information, the main outcomes will be reported.

When:
Access will begin six months after the publication of the results

To whom:
The data and documentation of this study will primarily be accessible to researchers working in academic and scientific institutions, while ensuring the privacy of participants. This includes faculty members, graduate students, and independent researchers who are engaged in fields relevant to this research.

Conditions:
All requests must be submitted in writing and should include clear explanations regarding the purpose of using the data. Applicants may be required to sign an agreement that includes a commitment to adhere to ethical principles and maintain the privacy of participants.

Where to obtain:
Applicants for obtaining the documents or data related to this study can refer to the following address:
Leila Eskandari
Email: Leilaeskandari4454@gmail.com"

How to obtain:
Applicants must submit an official request that includes personal information, the purpose of the request, and the type of data required. Upon receiving the request, the research team will conduct an initial review. After the necessary evaluations, a final decision will be made regarding the approval or rejection of the request. Applicants will be informed of the outcome via email or phone contact.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Afsaneh Keramat</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Haft-e Tir Square - Shahroud University of Medical Sciences and Health Services"</address>
        <city>Shahroud</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3614773943</zip>
        <telephone>+98 23 3239 5050</telephone>
        <email>info@shmu.ac.ir</email>
        <affiliation>Shahroud University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Leila Eskandari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No.37, yaser Street , valiasr Blvd. semnan</address>
        <city>semnan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3519693117</zip>
        <telephone>+98 23 3334 6290</telephone>
        <email>Leilaeskandari4454@gmail.com</email>
        <affiliation>Shahroud University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Written consent to participate in the study
Women aged between 18 and 35 years
Iranian nationality
Living with a spouse under the same roof
Full consciousness and acceptable hearing and speaking ability to receive training and respond to questions
Literacy in reading and writing.
Resident of Semnan city.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>35 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>One partner has infertility-related issues.
Women who have undergone hysterectomy or tubectomy.</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>Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>All midwives and health caregivers from the healthcare centers of Hazrat Rouhollah, Bahar, and Tadbir in Semnan are invited to participate in training classes aimed at empowering midwives. The educational content of these classes is based on in-depth qualitative interviews and a systematic review derived from the results of a doctoral thesis with the code IR.SHMU.REC.1401.153. The training will be conducted in the form of a two-day workshop totaling 12 hours.                                        Workshop Topics: Day 1:Communication skillsCounseling skills in pre-pregnancy services Childbearing counseling.                                             Day 2:Infertility counselingPersuasion against abortionConsequences of having a single childTrained midwives, after completing the educational courses, will seek eligible women for study participation and obtain consent to assign them to either the intervention or control group. Those placed in the intervention group will receive face-to-face childbearing counseling sessions lasting 20 minutes, once a week for four weeks.</i_keyword>
      <i_keyword>Control Group: Eligible women at health centers will be invited to receive routine counseling until the required sample size is reached, and fertility intention will also be assessed in this group.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Fertility Motivation of Only-Child Women. Timepoint: Before the intervention and one month after the intervention. Method of measurement: Miller's Fertility Motivation Questionnaire.</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>2024-12-01</approval_date>
        <contact_name>Ethics committee of shahroud university of medical Sciences</contact_name>
        <contact_address>No.37, Yaser street., Valiasr blvd. semnan Semnan Semnan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
