<?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>IRCT2017050133743N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2017-05-31</date_registration>
      <primary_sponsor>Islamic Azad University</primary_sponsor>
      <public_title>Effect of physical activity during pregnancy on development of Motor, Cognitive and Social skills in infants</public_title>
      <acronym></acronym>
      <scientific_title>Effect of physical activity during pregnancy on development of Motor, Cognitive and Social skills in infants</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2016-07-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>40</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/25949</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: it allocated participants 1:1 to the experimental (n=20) or the control group (n=20), using a computer random number generator.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Normal pregnancy.</hc_freetext>
      <i_freetext>Intervention 1: After receiving consent, the experimental group participated from the end of twenty-third week of pregnancy in an intervention period of about 8 weeks with 16 sessions of activity. The activity time was 50 minutes and it was consisted of two parts. The first part includes a 5 minute warm-up, specialized training, such as walking at moderate intensity (60-75 percent of maximum heart rate), massage, relaxation, and 5 minutes of cooling down. In the first part of training time from 25 minutes rose to 40 minutes in the last week. In the second part 10 minutes of teaching breathing skills and correctly position were taught to them. The selected movements were carried out with the approval of a gynecologist and obstetrician monitoring. Intervention 2: The pregnant women in control group were selected randomly and received usual care during pregnancy. They were not banned from physical activity, but base on their report, they did not follow regular physical activity.</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:
to present the data through articles

When:
one year later

To whom:
all people

Conditions:
to share data

Where to obtain:
Journals

How to obtain:
send- referring- publish

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Najmeh-Alsadat Shojaeian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Islamic Azad University, Bojnourd branch, Daneshgah blvd.</address>
        <city>Bojnourd</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9413913611</zip>
        <telephone>+98 58 3229 6982</telephone>
        <email>shojaeian@bojnourdiau.ac.ir</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Masoumeh Shojaei</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Alzahra Universityو Deh Vanak</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9413913611</zip>
        <telephone>+98 21 8804 1468</telephone>
        <email>m.shojae@alzahra.ac.ir</email>
        <affiliation>Alzahra University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>The inclusion criteria for the study were: all nulliparous pregnant women; non-athletes and house wives who admitted to city hospitals and prenatal care centers of Bojnurd. They had a gestational age of 23 to 34 weeks and according to their health records, body mass index (BMI) before pregnancy (20 to 24.9 kilograms per square meter) was normal. Similarly they had a normal singleton pregnancy at term (37-41 weeks) with the birth of a healthy baby (without any apparent anomalies). The subjects had no previous history of any underlying disease and were controlled based on their medical records.</inclusion_criteria>
      <agemin>22 years</agemin>
      <agemax>30 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>Z34</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Supervision of normal pregnancy</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Lifestyle</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>After receiving consent, the experimental group participated from the end of twenty-third week of pregnancy in an intervention period of about 8 weeks with 16 sessions of activity. The activity time was 50 minutes and it was consisted of two parts. The first part includes a 5 minute warm-up, specialized training, such as walking at moderate intensity (60-75 percent of maximum heart rate), massage, relaxation, and 5 minutes of cooling down. In the first part of training time from 25 minutes rose to 40 minutes in the last week. In the second part 10 minutes of teaching breathing skills and correctly position were taught to them. The selected movements were carried out with the approval of a gynecologist and obstetrician monitoring.</i_keyword>
      <i_keyword>The pregnant women in control group were selected randomly and received usual care during pregnancy. They were not banned from physical activity, but base on their report, they did not follow regular physical activity.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Motor, Cognitive and Communication Skills. Timepoint: 1 and 3 months after delivery. Method of measurement: Ages and Stages III: In this study, Motor development information of infants were obtained by Peabody Development Motor scale (PDMS-2), and cognitive and social development by Ages and Stages Questionnaire (ASQ III) questionnaire. The Peabody Developmental Motor Scales are used to assess the development of motor skills from birth through 5 years. The ASQ Questionnaire is the screening questionnaire of development in five areas of development (gross motor, fine motor, communication, problem solving, and social personal) to assess infants and declares developmental situation compared to the cut-off points. The questionnaire included demographic questions in the first section and in the next section, child development be evaluated with questions and answers "Yes, sometimes, and yet not". The time required to meet 10 -15 minutes for the parents. Totally,  30 questions was intended and for each question, highest score was 10 and 60 for each area. ASQ-3 is reliable and valid. ASQ-3 has excellent sensitivity (0.86) and specificity (0.85) that has adequate accuracy for screening. Strong test-retest reliability of 0.75 to 0.82, inter-rater reliability by comparing the filled-in forms to parents and professional examiners was 0.93.</prim_outcome>
      <prim_outcome>Motor, cognitive and Personal- social skills. Timepoint: 1 and 3 months after delivery. Method of measurement: The Peabody Developmental Motor Scales are used to assess the development of motor skills from birth through 5 years. In this study, the gross motor subscales included reflex, stationary, locomotion and fine motor subscales were grasping, and visual-motor integration were used. Each infant’s raw scores were eventually turned into standard scores and Development Motor Quotient (DMQ) Ages and Stages III: In this study, Ages and stages Questionnaire III (ASQ 3) was used to evaluate the development rate of Personal- Social skills component in 1 &amp;3 months. The ASQ Questionnaire is the screening questionnaire of development in five areas of development (gross motor, fine motor, communication, problem solving, and social personal) to assess infants and declares developmental situation compared to the cut-off points. The questionnaire included demographic questions in the first section and in the next section, child development be evaluated with questions and answers "Yes, sometimes, and yet not". The time required to meet 10 -15 minutes for the parents. Totally,  30 questions was intended and for each question, highest score was 10 and 60 for each area. ASQ-3 is reliable and valid. ASQ-3 has excellent sensitivity (0.86) and specificity (0.85) that has adequate accuracy for screening. Strong test-retest reliability of 0.75 to 0.82, inter-rater reliability by comparing the filled-in forms to parents and professional examiners was 0.93.</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>Islamic Azad University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2016-01-02</approval_date>
        <contact_name>Islamic Azad University, science and research branch, Tehran</contact_name>
        <contact_address>Sattari highway, Hesarak blvd. بجنورد North Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2016-02-01</approval_date>
        <contact_name>North Khorasan University of Medical Sciences and Health Services</contact_name>
        <contact_address>South Shariatti St., Karimi Rad Alley Bojnourd North Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
