<?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>IRCT20160527028109N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-03-06</date_registration>
      <primary_sponsor>Iran University of Medical Sciences</primary_sponsor>
      <public_title>Evaluation of a new method used for uterine closure during cesarean section on the integrity and thickness of uterine scar.</public_title>
      <acronym></acronym>
      <scientific_title>Evaluation of a new method used for uterine closure during cesarean section on the integrity and thickness of uterine scar.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-03-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>70</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/28623</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study 70 pregnant women will be divided into two groups of 35 each using a computer-generated table of random numbers, Blinding description: Double blinding (blinding participants, and investigators consisting of  statistician and specialist in sonography) will be used to reduce the selection bias.</study_design>
      <phase>N/A</phase>
      <hc_freetext>New method for uterine closure during cesarean delivery.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: In intervention group cesarean section incision will be closed with new technique. The surgical technique in this group is described as follows: Step 1. After securing the angle of the incision, a full thickness needle bite is taken starting 1 cm away from the margin of the incision and coming out in an oblique fashion at the junction of the myometrium and decidua of the lower edge of the incision. We then enter at the junction of the myometrium and decidua of the upper edge of the incision, and come out 1 cm away from the margin of the upper edge. Step 2.  Without changing the direction of the needle, a superficial bite about 0.5 cm away from the edge of incision with depth of 0.5 cm  is encircling the outer margins.Step 3. At this stage, two loose loops are formed at the cranial and caudal end.The assistant will pull the first and then the second loops until the loops get tightened by pulling the thread.The surgeon continues the same process for the next bite. This technique will ensure full thickness decidua-to decidua, myometrium-to-myometrium and serosa-to serosa approximation of the uterine cut margins with good homeostasis. Antibiotic administration is according to the standard protocol. Intervention 2: In control group cesarean section incision will be closed by the conventional technique.</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 There is no more information.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Kobra Tahermanesh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Rasoul Akram Hospital, Satarkhan St, Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1449614535</zip>
        <telephone>+98 21 64351</telephone>
        <email>tahermanesh.k@iums.ac.ir</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Kobra Tahermanesh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Rasoul Akram Hospital, Satarkhan St, Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1449614535</zip>
        <telephone>+98 21 64351</telephone>
        <email>tahermanesh.k@iums.ac.ir</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Pregnant women submitted to cesarean section for the first time</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Presence of uterine anomalies with or without previous repair.
Presence of uterine myoma at the site of caesarean incision
History of myomectomy at site of caesarean incision
Presence of placenta previa and placenta accrete.
Prolonged rupture of membranes without chorioamnionitis criteria (consist of fever, uterine tenderness…)
Rupture of membranes with chorioamnionitis criteria (consist of fever, uterine tenderness…)</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>Treatment - Surgery</i_code>
      <i_code>Treatment - Surgery</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: In intervention group cesarean section incision will be closed with new technique. The surgical technique in this group is described as follows: Step 1. After securing the angle of the incision, a full thickness needle bite is taken starting 1 cm away from the margin of the incision and coming out in an oblique fashion at the junction of the myometrium and decidua of the lower edge of the incision. We then enter at the junction of the myometrium and decidua of the upper edge of the incision, and come out 1 cm away from the margin of the upper edge. Step 2.  Without changing the direction of the needle, a superficial bite about 0.5 cm away from the edge of incision with depth of 0.5 cm  is encircling the outer margins.Step 3. At this stage, two loose loops are formed at the cranial and caudal end.The assistant will pull the first and then the second loops until the loops get tightened by pulling the thread.The surgeon continues the same process for the next bite. This technique will ensure full thickness decidua-to decidua, myometrium-to-myometrium and serosa-to serosa approximation of the uterine cut margins with good homeostasis. Antibiotic administration is according to the standard protocol.</i_keyword>
      <i_keyword>In control group cesarean section incision will be closed by the conventional technique.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The primary outcomes are uterine closure time and primary postpartum hemorrhage. Timepoint: During and the day after surgery. Method of measurement: Chronometer, Complete Blood Count(CBC), Medical records of patients.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>The secondary outcome is to compare the residual myometrial thickness and the depth of cesarean section scar defect after uterine incision closure using the new technique with the conventional method. Timepoint: 3 months after the surgry. Method of measurement: Ultrasound examination will be performed 3 months after the operation to assess the integrity of scar by measuring the residual myometrial thickness and the depth of the possible scar defect.</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>2017-12-14</approval_date>
        <contact_name>Ethics committee of Iran University of Medical Sciences</contact_name>
        <contact_address>Iran University of Medical Sciences, Hemmat Highway, Tehran Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
