<?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>IRCT20171106037279N4</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-04-17</date_registration>
      <primary_sponsor>Ahvaz University of Medical Sciences</primary_sponsor>
      <public_title>Effect of continuity of team care model on safe motherhood indicators</public_title>
      <acronym></acronym>
      <scientific_title>Effect of implementation continuity of team midwifery care model on safe motherhood indicators</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-04-19</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>200</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/67998</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Health service research, Randomization description: The study subjects will be assigned to each of the control and intervention groups by random block method using blocks 4 and 6 and will be divided into two groups with a ratio of 1:1. Thus, the number of 10 blocks of 6 and 16 blocks of 4 will be randomly extracted using WIN PEPI software. In each of the blocks of 6, 3 people will be related to the control group and 3 people will be related to the intervention group, also in each of the blocks of 4 people, 2 people will be related to the control group and 2 people will be related to the intervention group. The placement order of each person is random. In order to hide the allocation, the type of intervention will be written on paper and placed inside opaque envelopes numbered consecutively, in this way, the researcher and the participant will not know the type of intervention until the intervention begins. Due to the nature of this study, it will not be possible to blind the researcher and the participant.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Low-risk pregnant Women.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Hiring a responsible midwife for every pregnant woman. This midwife is a member of the management team and provides direct care during the prenatal, delivery, and postpartum stages. If pregnant women need special care, the midwife will refer them to the specialist and will take feedback. The responsible midwife will continuously be available for pregnant women in different settings of homes, health centers, and hospitals. Intervention 2: Control group: They will receive routine care. In a routine way, pregnant women refer to the health center. There is no responsible midwife or continuous communication with the caregiver. The majority of women are under the supervision of specialists, regardless of whether they are high-risk or low-risk. Caregivers are frequently changed during pregnancy, delivery and after delivery, and care is received by unfamiliar caregivers.</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:
Demographic information and information obtained from the used questionnaire can be shared

When:
After publishing the article in the journal

To whom:
Researchers, Department of Medical Sciences

Conditions:
Use to treat other patients

Where to obtain:
Email farzanehnasiri100@ gmail.com farzaneh nasiri

How to obtain:
Send message via email

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Farzaneh Nasiri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 45, 15 Muftah St</address>
        <city>QOM</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1985717443</zip>
        <telephone>+98 919 453 6915</telephone>
        <email>farzanehnasiri@sbmu.ac.ir</email>
        <affiliation>Ahvaz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Farzaneh Nasiri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 45, 15 Muftah St</address>
        <city>QOM</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>0375314855</zip>
        <telephone>+98 25 3423 1395</telephone>
        <email>farzanehnasiri@sbmu.ac.ir</email>
        <affiliation>Ahvaz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Pregnant Women aged 18 to 35 years
Iranian
Singleton pregnancy
First pregnancy visit (less than 12 weeks of pregnancy)
Low-risk pregnancy</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>35 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Women with a history of infertility
A history of anxiety or hospitalization in psychiatric wards</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>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Hiring a responsible midwife for every pregnant woman. This midwife is a member of the management team and provides direct care during the prenatal, delivery, and postpartum stages. If pregnant women need special care, the midwife will refer them to the specialist and will take feedback. The responsible midwife will continuously be available for pregnant women in different settings of homes, health centers, and hospitals.</i_keyword>
      <i_keyword>Control group: They will receive routine care. In a routine way, pregnant women refer to the health center. There is no responsible midwife or continuous communication with the caregiver. The majority of women are under the supervision of specialists, regardless of whether they are high-risk or low-risk. Caregivers are frequently changed during pregnancy, delivery and after delivery, and care is received by unfamiliar caregivers</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The level of satisfaction with childbirth in the McKay questionnaire. Timepoint: After delivery. Method of measurement: Mackey childbirth satisfaction rating scale.</prim_outcome>
      <prim_outcome>Score of depression, anxiety and stress in the questionnaire. Timepoint: Third trimester of pregnancy and 6 weeks after delivery. Method of measurement: Depression anxiety and Stress Scale.</prim_outcome>
      <prim_outcome>Antenatal care quality score in pregnancy care quality questionnaire. Timepoint: After delivery. Method of measurement: The Quality Prenatal Care Questionnaire.</prim_outcome>
      <prim_outcome>Consequences of pregnancy. Timepoint: End of intervention. Method of measurement: View the hospital record.</prim_outcome>
      <prim_outcome>Neonatal consequences. Timepoint: End of intervention. Method of measurement: View the hospital record.</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>Ahvaz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-04-08</approval_date>
        <contact_name>Ethics committee of Ahvaz University of Medical Sciences</contact_name>
        <contact_address>No. 45, 15 Muftah St Qom Ghoum Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
