<?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>IRCT201408318801N9</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2016-08-15</date_registration>
      <primary_sponsor>Vice chancellor for research, Shahid Beheshti University of Medical Sciences</primary_sponsor>
      <public_title>Development and evaluating a model of continuous midwifery care during pregnancy, labor and postpartum, an action research study</public_title>
      <acronym></acronym>
      <scientific_title>Evaluation the effect of continuous midwifery care model during pregnancy, labor and postpartum on maternal and neonatal</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2015-03-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>200</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/9290</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Health service research.</study_design>
      <phase>3</phase>
      <hc_freetext>pregnancy.</hc_freetext>
      <i_freetext>Intervention 1: The intervention in case group includes: Hiring a responsible midwife for every pregnant woman. This midwife is a member of management team and provides direct care during prenatal, delivery and postpartum stages. If pregnant women need special care, the midwife will refer her to the specialist and will take feedback. Responsible midwife will continuously be available for pregnant women in different settings of home, health centers and hospital. Intervention 2: The control group will receive routine care. In routine method, pregnant women refer to health center. There is not responsible midwife or continuous relationship with care provider. Most of women are under supervision of specialist no matter, they are high or low risk. Care providers change repeatedly during prenatal, delivery and postpartum stages. Care provider may be unknown for women.</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></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Azam Bagheri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Nurse Street, Ravand High Way</address>
        <city>Kashan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 31 5554 0021</telephone>
        <email>asambagheri@yahoo.com</email>
        <affiliation>Kashan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Masoumeh Simbar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Crossing Vali-Asr Neiayesh</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 21 8820 2519</telephone>
        <email>msimbar@yahoo.com</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: &#13;
The Low risk pregnant women that: &#13;
- Their gestational age is under fourteen weeks &#13;
- They have not any diseases&#13;
- They have not  previous high risk pregnancy &#13;
- They have not history for infertility &#13;
- They have not previous cesarean section &#13;
- They have not previous abdominal surgery &#13;
Exclusion criteria: &#13;
- Their pregnancy be high risk  &#13;
-  They have no desire to continue staying in the study</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>35 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>000-099</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Supervision of normal pregnancy, unspecified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>The intervention in case group includes: Hiring a responsible midwife for every pregnant woman. This midwife is a member of management team and provides direct care during prenatal, delivery and postpartum stages. If pregnant women need special care, the midwife will refer her to the specialist and will take feedback. Responsible midwife will continuously be available for pregnant women in different settings of home, health centers and hospital.</i_keyword>
      <i_keyword>The control group will receive routine care. In routine method, pregnant women refer to health center. There is not responsible midwife or continuous relationship with care provider. Most of women are under supervision of specialist no matter, they are high or low risk. Care providers change repeatedly during prenatal, delivery and postpartum stages. Care provider may be unknown for women.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Maternal satisfaction. Timepoint: 1 month after intervention. Method of measurement: Questionnaire.</prim_outcome>
      <prim_outcome>Maternal outcomes. Timepoint: at the end of intervention. Method of measurement: observe the hospital folder and interview.</prim_outcome>
      <prim_outcome>Neonatal outcomes. Timepoint: at the end of intervention. Method of measurement: observe the hospital folder.</prim_outcome>
      <prim_outcome>Number of visits in pregnancy. Timepoint: at the end of intervention. Method of measurement: observe the hospital folder.</prim_outcome>
      <prim_outcome>Number of sonography. Timepoint: at the end of intervention. Method of measurement: observe the hospital folder.</prim_outcome>
      <prim_outcome>Fetal death before or after 24 weeks. Timepoint: at the end of intervention. Method of measurement: observe the hospital folder and interview.</prim_outcome>
      <prim_outcome>Hospitalization. Timepoint: at the end of intervention. Method of measurement: observe the hospital folder and interview.</prim_outcome>
      <prim_outcome>Bleeding before delivery. Timepoint: at the end of intervention. Method of measurement: observe the hospital folder and interview.</prim_outcome>
      <prim_outcome>Husband presence in visits. Timepoint: at the end of intervention. Method of measurement: observe the hospital folder and interview.</prim_outcome>
      <prim_outcome>Induction. Timepoint: at the end of intervention. Method of measurement: observe the hospital folder.</prim_outcome>
      <prim_outcome>Physiologic delivery. Timepoint: at the end of intervention. Method of measurement: observe the hospital folder.</prim_outcome>
      <prim_outcome>Analgesic and anesthesia. Timepoint: at the end of intervention. Method of measurement: observe the hospital folder.</prim_outcome>
      <prim_outcome>Duration of labor. Timepoint: at the end of intervention. Method of measurement: observe the hospital folder.</prim_outcome>
      <prim_outcome>Duration of hospitalization. Timepoint: at the end of intervention. Method of measurement: observe the hospital folder.</prim_outcome>
      <prim_outcome>Delivery type. Timepoint: at the end of intervention. Method of measurement: observe the hospital folder.</prim_outcome>
      <prim_outcome>Episiotomy. Timepoint: at the end of intervention. Method of measurement: observe the hospital folder.</prim_outcome>
      <prim_outcome>Perineal laceration. Timepoint: at the end of intervention. Method of measurement: observe the hospital folder and interview.</prim_outcome>
      <prim_outcome>Gestational age at the termination. Timepoint: at the end of intervention. Method of measurement: observe the hospital folder and interview.</prim_outcome>
      <prim_outcome>Neonatal weight. Timepoint: at the end of intervention. Method of measurement: observe the hospital folder.</prim_outcome>
      <prim_outcome>Preterm neonate. Timepoint: at the end of intervention. Method of measurement: observe the hospital folder and interview.</prim_outcome>
      <prim_outcome>5th minute Apgar score. Timepoint: at the end of intervention. Method of measurement: observe the hospital folder.</prim_outcome>
      <prim_outcome>NICU hospitalization. Timepoint: at the end of intervention. Method of measurement: observe the hospital folder and interview.</prim_outcome>
      <prim_outcome>Depression after delivery. Timepoint: at the end of intervention. Method of measurement: observe the hospital folder and interview.</prim_outcome>
      <prim_outcome>Breast feeding onset. Timepoint: at the end of intervention. Method of measurement: interview.</prim_outcome>
      <prim_outcome>Continuous pain after delivery. Timepoint: at the end of intervention. Method of measurement: interview.</prim_outcome>
      <prim_outcome>Expenditure. Timepoint: at the end of intervention. Method of measurement: observe the hospital folder and calculation.</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>Vice chancellor for research, Shahid Beheshti University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2014-10-11</approval_date>
        <contact_name>Ethics committee of Kashan University of Medical Sciences</contact_name>
        <contact_address>Nurse street, Ravand High Way Kashan  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
