<?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>IRCT20091023002624N26</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-08-03</date_registration>
      <primary_sponsor>Iran University of Medical Sciences</primary_sponsor>
      <public_title>Treatment of preterm  labor</public_title>
      <acronym></acronym>
      <scientific_title>A comparative study on the efficacy of nifedipine and indomethacin for prevention of preterm birth as monotherapy and combination therapy</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2016-05-01</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>150</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/31694</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: simple individual randomization using sealed envelops, Blinding description: The participants and the investigators did not know how the patients were allocated to the three groups. The groups were named as A, B and C and placebo were used to blind them.</study_design>
      <phase>2-3</phase>
      <hc_freetext>Condition 1: preterm birth, Preterm delivery, preterm uterine contractions,  preterm labor. Condition 2: preterm birth, Preterm delivery, preterm uterine contractions,  preterm labor. Condition 3: preterm birth, Preterm delivery, preterm uterine contractions,  preterm labor.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: group A; 100 mg rectal indomethacin was administered along with an oral placebo. If the patient responded to the initial treatment after two hours, 25 mg of oral indomethacin was administered every 4 hours plus placebo. The maximum daily dosage of indomethacin was 200 mg/day and the maximum duration of administration was 48 hours. Intervention 2: Intervention group: group B; 20 mg oral nifedipine was administered along with a rectal placebo. After 90 minutes, more 20 mg of oral nifedipine was administered. In case of responding to the initial treatment, 20 mg of oral nifedipine was continued every 3 hours for 72 hours at a maximum dose of 180 mg per day, with a placebo that was given every 4 hours (similar to the indomethacin protocol). Intervention 3: Intervention group: group C; a combination of rectal indomethacin and oral nifedipine was administered per protocol as mentioned above.</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:
Presenting at a paper, congress or seminars.

When:
After publication of the paper

To whom:
Iran University of Medical Sciences

Conditions:
Permission from Iran University of Medical Sciences

Where to obtain:
From Iran University of Medical Sciences

How to obtain:
Request from Iran University of Medical Sciences.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Maryam Kashanian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Molavi Street</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۱۱۶۸۷۴۳۵۱۴</zip>
        <telephone>+98 21 5563 3244</telephone>
        <email>maryamkashanian@yahoo.com</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Maryam Kashanian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Molavi Street</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۱۱۶۸۷۴۳۵۱۴</zip>
        <telephone>+98 21 5563 3244</telephone>
        <email>maryamkashanian@yahoo.com</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>gestational age of 26 to 34 weeks
singleton
uterine contractions with a frequency of at least 4 forceful uterine contractions per 20 minutes or a cervical dilatation of minimum 1 cm and minimum 50% cervical effacement.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>40 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>rupture of membrane
intrauterine fetal death
cervical dilatation of more than 5 cm
multiple pregnancy
receiving tocolytic within past 24 hours
polyhydramnios
preeclampsia and eclampsia
vaginal bleeding more than bloody show
any maternal and fetal condition that contradict with receiving tocolitics
severe fetal anomalies contradict fetal life
fetal distress</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>O60</hc_code>
      <hc_code>O60.1</hc_code>
      <hc_code>O60.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Preterm labour and delivery</hc_keyword>
      <hc_keyword>Preterm spontaneous labour with preterm delivery</hc_keyword>
      <hc_keyword>Preterm labor without delivery</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: group A; 100 mg rectal indomethacin was administered along with an oral placebo. If the patient responded to the initial treatment after two hours, 25 mg of oral indomethacin was administered every 4 hours plus placebo. The maximum daily dosage of indomethacin was 200 mg/day and the maximum duration of administration was 48 hours.</i_keyword>
      <i_keyword>Intervention group: group B; 20 mg oral nifedipine was administered along with a rectal placebo. After 90 minutes, more 20 mg of oral nifedipine was administered. In case of responding to the initial treatment, 20 mg of oral nifedipine was continued every 3 hours for 72 hours at a maximum dose of 180 mg per day, with a placebo that was given every 4 hours (similar to the indomethacin protocol).</i_keyword>
      <i_keyword>Intervention group: group C; a combination of rectal indomethacin and oral nifedipine was administered per protocol as mentioned above.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Inhibiting uterine contractions for 48 hours. Timepoint: 48 hours after intervention. Method of measurement: contraction monitoring by tocometer.</prim_outcome>
      <prim_outcome>Delivery before 37 weeks of gestation. Timepoint: Birth date. Method of measurement: Data sheets.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Inhibiting the contractions in the first 2 hours after intervention. Timepoint: 2 hours after intervention. Method of measurement: Tocometer.</sec_outcome>
      <sec_outcome>Delivery within 7 days after intervention. Timepoint: 7 days after intervention. Method of measurement: Birth date.</sec_outcome>
      <sec_outcome>Gestational age at the time of birth. Timepoint: time of birth. Method of measurement: birth date.</sec_outcome>
      <sec_outcome>Duration of prolongation of pregnancy. Timepoint: birth date. Method of measurement: Data sheets.</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>Investigator</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-06-17</approval_date>
        <contact_name>Ethics committee of Iran University of Medical Sciences.</contact_name>
        <contact_address>Hemmat Highway, Chamran Cross. Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
