<?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>IRCT20210703051764N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-07-15</date_registration>
      <primary_sponsor>Ahvaz University of Medical Sciences</primary_sponsor>
      <public_title>The Effect of Group Prenatal Care on Adolescent Pregnancy Outcomes.</public_title>
      <acronym></acronym>
      <scientific_title>The Effect of Group Prenatal Care on Adolescent Pregnancy Outcomes and explaining the experience of this model of prenatal care: A Mixed method study</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-08-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>294</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/57234</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Eligible women will randomly assigned into two groups of routine (individual) prenatal care or group prenatal care using block randomization with a block size of 4 and 6 and allocation ratio of 1:1. Thus, after listing all possible situation of 4 and 6 blocks and assigning a number to each of them using a computer random number table with a 1: 1 ratio, participants will be allocated into two groups, namely routine prenatal care and group prenatal care. For allocation concealment, each woman will received a code and all codes will be kept in an opaque envelope until the time of intervention. Sequencing of allocation and preparation of envelopes will be done by a person that will not involve in sampling and data collection. The researcher and the participant will not aware of the groups and the intervention that they received until the commencement of intervention.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Group prenatal care.</hc_freetext>
      <i_freetext>Intervention 1: In the intervention group from 16 to 20 weeks of pregnancy, 5 to 6 pregnant adolescents women will be allocated in a group, and will receive 4 or 5 prenatal care (weeks 16-20, 30-24, 34-31, 37-35, 38). The first 30 to 45 minutes of each prenatal care session will be included measuring uterine height and fetal heart rate, which will be performed by the researcher. The fetal heart rate will be heard and recorded by one of the women in the group using Sonicaid. Then, weight and blood pressure will be measured in groups by adolescent pregnant women under the supervision of the researcher. Adolescent pregnant women will be taught how to take blood pressure using a digital sphygmomanometer, as well as how to measure weight, so that women can measure each other's blood pressure and weight. Pregnant women will be given the opportunity to discuss learning this skill. Then, the prenatal care education will be done in the form of group discussions, according to the educational content specific to each week of pregnancy in the booklet prepared by National Instruction of the Ministry of Health and Medical Education. In each session, the researcher will encourage women to participate in prenatal care education discussions through open-ended questions. In order to express their information, knowledge and experiences in the field of care, their information and knowledge will be evaluated by the researcher. The necessary information and strategies to promote health, will be provided by the researcher in simple language. Intervention 2: Control group; Pregnant women in the control group will receive routine prenatal care from health care centers, and the researcher will not be involved.</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 data can be published after the accomplishment of the dissertation

When:
One year after completing the dissertation

To whom:
Ahvaz Jundishapur University of Medical Sciences; Hospital and University researchers

Conditions:
Data will be available after publication in journals.

Where to obtain:
Fatemeh Malchi; Email; machi.fatemeh52@gmail.com

How to obtain:
The information will be available through the publication of the article. But if more information is needed, the request should be sent via email

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Parvi Abedi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Golestan Blvd; Department of Midwifery; Nursing and Midwifery School; Ahvaz Jundishapur University of Medical Sciences</address>
        <city>Ahvaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>61357-15794</zip>
        <telephone>+98 61 3373 8331</telephone>
        <email>parvinabedi@ymail</email>
        <affiliation>Ahvaz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Fatemeh Malchi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No4; Bahman9; Bahmani Ave</address>
        <city>Bushehr</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7516995383</zip>
        <telephone>+98 77 3344 1891</telephone>
        <email>malchi.fatemeh52@gmail.com</email>
        <affiliation>Ahvaz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>15-19 years old
First and second pregnancies
Singleton pregnancy
low-risk pregnancy
Gestational age 16-20 wk</inclusion_criteria>
      <agemin>15 years</agemin>
      <agemax>19 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Unwanted pregnancy</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>N/A</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>In the intervention group from 16 to 20 weeks of pregnancy, 5 to 6 pregnant adolescents women will be allocated in a group, and will receive 4 or 5 prenatal care (weeks 16-20, 30-24, 34-31, 37-35, 38). The first 30 to 45 minutes of each prenatal care session will be included measuring uterine height and fetal heart rate, which will be performed by the researcher. The fetal heart rate will be heard and recorded by one of the women in the group using Sonicaid. Then, weight and blood pressure will be measured in groups by adolescent pregnant women under the supervision of the researcher. Adolescent pregnant women will be taught how to take blood pressure using a digital sphygmomanometer, as well as how to measure weight, so that women can measure each other's blood pressure and weight. Pregnant women will be given the opportunity to discuss learning this skill. Then, the prenatal care education will be done in the form of group discussions, according to the educational content specific to each week of pregnancy in the booklet prepared by National Instruction of the Ministry of Health and Medical Education. In each session, the researcher will encourage women to participate in prenatal care education discussions through open-ended questions. In order to express their information, knowledge and experiences in the field of care, their information and knowledge will be evaluated by the researcher. The necessary information and strategies to promote health, will be provided by the researcher in simple language.</i_keyword>
      <i_keyword>Control group; Pregnant women in the control group will receive routine prenatal care from health care centers, and the researcher will not be involved.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Average weight gain of adolescent pregnant mothers. Timepoint: End of the intervention(38-40 wk). Method of measurement: scale.</prim_outcome>
      <prim_outcome>Preterm labor. Timepoint: During the intervention. Method of measurement: mean gestational age.</prim_outcome>
      <prim_outcome>Duration of first and second stage of labor. Timepoint: End of the intervention(labor). Method of measurement: Measuring the mean of the first and second stages of labor (minutes).</prim_outcome>
      <prim_outcome>Select the type of delivery. Timepoint: End of the intervention. Method of measurement: type of delivery(normal vaginal delivery or cesarean delivery).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Empowerment of pregnant adolescents. Timepoint: End of the intervention. Method of measurement: Kameda Empowerment Questionnaire.</sec_outcome>
      <sec_outcome>Fear of child birth. Timepoint: Before  and after delivery. Method of measurement: Wijma Delivery Expectancy/Experience Questionnaire version A and B.</sec_outcome>
      <sec_outcome>Apgar score of the 1st and 5th  minutes after birth. Timepoint: End of the intervention( at child birth). Method of measurement: Apgar score.</sec_outcome>
      <sec_outcome>Birth weight. Timepoint: End of the intervention(at birth). Method of measurement: Scale.</sec_outcome>
      <sec_outcome>Duration of neonate hospitalization in Neonatal Intensive Care Unit. Timepoint: After the intervention (after the child birth ). Method of measurement: Mean duration of hospitalization.</sec_outcome>
      <sec_outcome>Type of feeding. Timepoint: After the end of intervention (after the child birth ). Method of measurement: 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>2021-07-02</approval_date>
        <contact_name>Ethics Committee of Ahvaz Jundishapur University of Medical Sciences</contact_name>
        <contact_address>Golestan Blvd, University Campus, Research Deputy of Ahvaz Jundishapur University of Medical Sciences, Ground Floor, Room No: 4 Ahvaz Khouzestan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
