<?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>IRCT2014041917341N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2017-10-15</date_registration>
      <primary_sponsor>Research Vice-Presidency Of Isfahan(Khorasgan) Islamic Azad University</primary_sponsor>
      <public_title>The effect of placental drainage on the duration of third stage of labour</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of  placenta drainage and routin  Method of  removal of placenta on the outcome of third Stage of Delivery.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2013-03-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>400</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/15966</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Outcome of third stage of labour.</hc_freetext>
      <i_freetext>Intervention 1: Routine intervention active management of third stage of labour (the control group): Immediately after the  birth of the baby, the umbilical cord is clamped with two forceps (at a distance of  4-5 cm in the fetus) and cut between them and the baby is placed in the baby's cot. 20 units of oxytocin immediately after delivery of  the baby is injected at 1000 cc of the ringer's syringe and infused  with a velocity of 20-10 ml / min (200-200 ml / min),then  clamped and cut umbilical cord of  baby and from that time on, we calculate the time with  the stopwatch, Check  signs of placental separation, For up to 30 minutes, we allow placenta  to be separated  spontaneously  and after the signs of separation of the placenta, With one hand, hold the uterus from the abdomen and with another  hand pull it down with a cord (Brandt- Andrew maneuver), and at the same time encourages the mother push  to delivery of placenta.  After the delivery  of the placenta, take it  with two hands and turn it until the membrance  are screwed and we pull out all membrance  with a gentle stretch. At this time, stop the stopwatch .  thus, the length of the third stage of labor is determined. Then massage the uterus and make sure of  its contraction. Then check the placenta and membrance to make sure that it is complete. In the absence of delivery of placenta up to 30 minutes or a large bleeding, the Manual removal of placenta is done. Intervention 2: Placental cord drainage active management of third stage of  labour( In the study group): All actions in this group are as before. Only after the birth of a baby When  the cord clamped and cut it and put the baby in the baby's cot, unclamped the cord  and left open to drain blood in a vessel until flow ceased. Cord is slightly wrinkled ( placenta drainage). And the rest of the actions are the same as the control group. Up to one hour after the delivery of the placenta  in both groups, the uterus contraction and the rate of receiving uterotonic drugs are checked.</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>Karimi Nazi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>University Blvd, Argavaniyeh, Jay street.</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 31 3535 4001</telephone>
        <email>karimi_nazli@khuisf.ac.ir</email>
        <affiliation>Isfahan (Khorasgan) Islamic Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Karimi Nazi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>University Blvd, Argavaniyeh, Jay street.</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 31 3568 8824</telephone>
        <email>karimi_nazli@khuisf.ac.ir</email>
        <affiliation>Isfahan (Khorasgan) Islamic Azad University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: Natural vaginal delivery; pregnancy with vertex presentation ; Term pregnancy (37-42 weeks); Singelton pregnancy; Absence placental disorders and  neonatal congenital anomaly in perinatal ultrasound examination; The absence of  medical and obstetric conditions in the mother.&#13;
&#13;
Exclusion criteria: previous history of curtage; Instrumental delivery(Vacum ,Forceps); Maternal coagulation disorder.</inclusion_criteria>
      <agemin>16 years</agemin>
      <agemax>43 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>O72,O73,O7</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Postpartum haemorrhage,Retained placenta and membranes, without haemorrhage,Other complications of labour and delivery, not elsewhere classified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Routine intervention active management of third stage of labour (the control group): Immediately after the  birth of the baby, the umbilical cord is clamped with two forceps (at a distance of  4-5 cm in the fetus) and cut between them and the baby is placed in the baby's cot. 20 units of oxytocin immediately after delivery of  the baby is injected at 1000 cc of the ringer's syringe and infused  with a velocity of 20-10 ml / min (200-200 ml / min),then  clamped and cut umbilical cord of  baby and from that time on, we calculate the time with  the stopwatch, Check  signs of placental separation, For up to 30 minutes, we allow placenta  to be separated  spontaneously  and after the signs of separation of the placenta, With one hand, hold the uterus from the abdomen and with another  hand pull it down with a cord (Brandt- Andrew maneuver), and at the same time encourages the mother push  to delivery of placenta.  After the delivery  of the placenta, take it  with two hands and turn it until the membrance  are screwed and we pull out all membrance  with a gentle stretch. At this time, stop the stopwatch .  thus, the length of the third stage of labor is determined. Then massage the uterus and make sure of  its contraction. Then check the placenta and membrance to make sure that it is complete. In the absence of delivery of placenta up to 30 minutes or a large bleeding, the Manual removal of placenta is done.</i_keyword>
      <i_keyword>Placental cord drainage active management of third stage of  labour( In the study group): All actions in this group are as before. Only after the birth of a baby When  the cord clamped and cut it and put the baby in the baby's cot, unclamped the cord  and left open to drain blood in a vessel until flow ceased. Cord is slightly wrinkled ( placenta drainage). And the rest of the actions are the same as the control group. Up to one hour after the delivery of the placenta  in both groups, the uterus contraction and the rate of receiving uterotonic drugs are checked.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Duration of 3rd stage of delivery. Timepoint: At the same time study. Method of measurement: Using a stopwatch in seconds.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Retained placenta. Timepoint: At the same time study. Method of measurement: The presence or absence of retention.</sec_outcome>
      <sec_outcome>Manual removal of placenta. Timepoint: At the same time study. Method of measurement: The number of cases of Manual removal of placenta.</sec_outcome>
      <sec_outcome>Postpartum hemorrhage. Timepoint: At the same time study. Method of measurement: Just a visual check.</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>Research Vice-Presidency Of Isfahan(Khorasgan) Islamic Azad University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-08-22</approval_date>
        <contact_name>Najafabad  Islamic Azad University</contact_name>
        <contact_address>University Sq, Najafabad, Isfahan, Iran Najafabad  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-08-22</approval_date>
        <contact_name>Isfahan (Khorasgan) Islamic Azad University</contact_name>
        <contact_address>University Blvd, Argavaniyeh, Jay street. Isfahan  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
