<?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>IRCT20200202046346N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-04-20</date_registration>
      <primary_sponsor>Iran University of Medical Sciences</primary_sponsor>
      <public_title>The effect of different types of serum therapy on maternal and fetal outcomes during childbirth</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the effect of serum administration of 1.3 and 2.3% Ringer Lactate and Normal Saline on duration of labor, Cesarean section, Serum bilirubin and glucose level and PH of neonatal cord blood in neonatal women undergoing labor induction</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-11-25</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>450</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/45555</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Other, Randomization description: After consciously satisfying the individuals, they are randomized by the number table method and divided into three groups. In this method, a number of cards or letters are selected by the researcher as the first group and the same.The number of cards is considered for the next group; then by merging the tasks together(On playing cards) A card is taken out and its allocation is recorded, and that card is returned to the other cards after leaving. Then the cards are merged again and another card is taken out. This process continues until a random sequence is reached according to the sample size. Also, the number of cards or names is not necessarily equal to the total number of samples. For example, theIn a three-group study with a sample size of 300 people and a group ratio of 1: 1, 3 cards can be used He prepared for each group. the software and people are divided into three groups, Blinding description: Thus, the subject and statistical analyst are unaware of the status of the allocation of the three groups to the study. The subject is not aware of the allocation status to the groups. The researcher who measures clinical and diagnostic measurements will not be aware of the individual's condition, and the statistical advisor will be unaware of the individual's allocation to the study groups. Only the supervisor, appointed by the university, was aware of the allocation of groups.</study_design>
      <phase>N/A</phase>
      <hc_freetext>labor.</hc_freetext>
      <i_freetext>Intervention 1: intervention Group 1: In this study, an equal number of pregnant women G 1 with Bishop Score less than 4 who have a pregnancy termination indication are included in the study.The first group during delivery (when the patient is brought to the delivery room to induce labor and is ready to give birth on a special bed) is injected with 125 cc of normal saline per minute and continues until after delivery and the birth of the baby, then will be disconnected. Intervention 2: intervention Group 2: In this study, an equal number of pregnant women G 1 with Bishop Score less than 4 who have a pregnancy termination indication are included in the study.The first group during delivery (when the patient is brought to the delivery room to induce labor and is ready to give birth on a special bed) is injected with 125 cc of 1/3-2/3 serum per minute and and continues until after delivery and the birth of the baby, then will be disconnected. Intervention 3: intervention Group 2: In this study, an equal number of pregnant women G 1 with Bishop Score less than 4 who have a pregnancy termination indication are included in the study.The first group during delivery (when the patient is brought to the delivery room to induce labor and is ready to give birth on a special bed) is injected with 125 cc of ringer  serum per minute and and continues until after delivery and the birth of the baby, then will be disconnected.</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is No more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mina Momeni</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Vice Chancellor for International affairs, Iran University of Medical Sciences, Shahid Hemmat Highway, Tehran, 1449614535, IRAN</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1449613545</zip>
        <telephone>+98 903 362 5067</telephone>
        <email>minamomeni20@yahoo.com</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mina Momeni</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Iran University of Medical Sciences, Shahid Hemmat Highway, Tehran, 1449614535, IRAN</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1449614535</zip>
        <telephone>+98 21 3625 6451</telephone>
        <email>momeni.mi@iums.ac.ir</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Gravid one
Bishop Score&lt;4
Pregnancy single fetus
Cephalic presentations
Gestational age more than 37 weeks</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Multiparity
Known heart disease that can't handle this fluid volume
Induction contraindications                                                                             Such as Intrauterine growth restriction (IUGR);                                                 Suspicion of Cephalopelvic disproportion (CPD);                             Breech show member
Patients undergoing cervical ripening</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>Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>intervention Group 1: In this study, an equal number of pregnant women G 1 with Bishop Score less than 4 who have a pregnancy termination indication are included in the study.The first group during delivery (when the patient is brought to the delivery room to induce labor and is ready to give birth on a special bed) is injected with 125 cc of normal saline per minute and continues until after delivery and the birth of the baby, then will be disconnected.</i_keyword>
      <i_keyword>intervention Group 2: In this study, an equal number of pregnant women G 1 with Bishop Score less than 4 who have a pregnancy termination indication are included in the study.The first group during delivery (when the patient is brought to the delivery room to induce labor and is ready to give birth on a special bed) is injected with 125 cc of 1/3-2/3 serum per minute and and continues until after delivery and the birth of the baby, then will be disconnected.</i_keyword>
      <i_keyword>intervention Group 2: In this study, an equal number of pregnant women G 1 with Bishop Score less than 4 who have a pregnancy termination indication are included in the study.The first group during delivery (when the patient is brought to the delivery room to induce labor and is ready to give birth on a special bed) is injected with 125 cc of ringer  serum per minute and and continues until after delivery and the birth of the baby, then will be disconnected.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The duration of labor. Timepoint: At the beginning of labor and after delivery. Method of measurement: the watch.</prim_outcome>
      <prim_outcome>Cesarean section. Timepoint: Postpartum. Method of measurement: Percent.</prim_outcome>
      <prim_outcome>Serum bilirubin level. Timepoint: After labor. Method of measurement: Dedicated experiments.</prim_outcome>
      <prim_outcome>Baby umbilical cord blood pH. Timepoint: After birth. Method of measurement: Dedicated experiments.</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>Iran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-11-24</approval_date>
        <contact_name>Ethics committee of Iran University of Medical Sciences</contact_name>
        <contact_address>Vice Chancellor for International affairs, Iran University of Medical Sciences, Shahid Hemmat Highway, Tehran, 1449614535, IRAN Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
