<?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>IRCT201709293027N39</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2017-11-10</date_registration>
      <primary_sponsor>Research Deputy of Tabriz University of Medical Sciences</primary_sponsor>
      <public_title>Comparison of the effects of Hyoscine and Acupressure on Hugo point on length of  delivery</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the effects of Hyoscine and Acupressure on Hugo point (LI 4) on Length of delivery stages in nuliparous women: A randomized controlled clinical trial.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-10-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>162</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/3009</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: Samples are compiled using computer software (http://www.random.org) by random blocking with the size of the triple and six blocks in three groups. To hide the assignment of the type of intervention on the paper, it will be numbered inside the bursting matte envelopes.</study_design>
      <phase>2</phase>
      <hc_freetext>Delivery.</hc_freetext>
      <i_freetext>Intervention 1: Acupuncture Hugo Point: At 5 cm dilatation, the Hugo point will be pressed gently for 30 seconds, and gradually the pressure will be added to become quite severe so that the patient feels numbed and heavy around the area. The scholar's finger will be held for 1 minute, and then the pressure will be reduced and released within 30 seconds. The pressure will continue for up to 20 minutes, and will be performed at the dilatation of 6, 8 and 10 cm. Intervention 2: Injection of Hyoscine: At the onset of the delivery phase (dilation of 5 cm), 20 milligrams of Hyoscine  will be injected muscularly and every 2 to 3 hours vaginal examination will be done. Primery outcomes that are active phase duration, se cond and third stage of delivery in a check list and a partialograph form will be recorded. Intervention 3: Control group: The researcher will attend the maternity clinic and all routine lab measures that will be performed in the two intervention groups will be performed except acupressure and hyosteine injections in the control group.</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>Fahimeh Sehhatie Shafaie</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Nursing and Midwifery, South Shariati Street</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 41134796770</telephone>
        <email>sehhatief@tbzmed.ac.ir</email>
        <affiliation>Tabriz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Fahimeh Sehhatie Shafaie</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Nursing and Midwifery, South Shariati Street</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 41334796969</telephone>
        <email>sehhatief@tbzmed.ac.ir</email>
        <affiliation>Tabriz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion Criteria: 18 to 35 years old, gestational age of 37 to 42 weeks (according to LMP or ultrasound in less than 12 weeks),nulliparous, singleton pregnancy, cephalic presentation, intact amniotic sac at examination, or passing Maximum 6 hours of rupture of the amniotic sac, spontaneous onset of uterine contraction, having low risk pregnancy (such as the absence of chronic disease like heart disease, hypertension, lung disease, diabetes, anemia, urinary tract infection, thyroid disease, and epilepsy; not having abortion, dead fetus, bleeding or any abnormality when referring to the hospital); absence of cephalopelvic disproportion (CPD) during vaginal examination; height over 145 cm; no lesion in hugo points; not presence of any disabilities that lead to communication problems for the mother (deafness, blindness, etc.).Exclusion Criteria: meconıum-rich amniotic fluid; Any need for emergent intervention in mothers and fetuses such as bleeding, Burst contractions, Labor accelerated, Fetal distress,Placenta Decolman.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>35 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>O80.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Spontaneous vertex delivery</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Acupuncture Hugo Point: At 5 cm dilatation, the Hugo point will be pressed gently for 30 seconds, and gradually the pressure will be added to become quite severe so that the patient feels numbed and heavy around the area. The scholar's finger will be held for 1 minute, and then the pressure will be reduced and released within 30 seconds. The pressure will continue for up to 20 minutes, and will be performed at the dilatation of 6, 8 and 10 cm.</i_keyword>
      <i_keyword>Injection of Hyoscine: At the onset of the delivery phase (dilation of 5 cm), 20 milligrams of Hyoscine  will be injected muscularly and every 2 to 3 hours vaginal examination will be done. Primery outcomes that are active phase duration, se cond and third stage of delivery in a check list and a partialograph form will be recorded.</i_keyword>
      <i_keyword>Control group: The researcher will attend the maternity clinic and all routine lab measures that will be performed in the two intervention groups will be performed except acupressure and hyosteine injections in the control group.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Lenght of active phase of labor. Timepoint: Every 2-3 hours, from the onset of the active phase of labor to its completion and the onset of the second stage of labor. Method of measurement: With vaginal exame and registration in the form of a partographer.</prim_outcome>
      <prim_outcome>The length of the second stage of labor. Timepoint: Every 30 minutes once, from the onset of the second stage of childbirth to its completion. Method of measurement: Via vaginal examination and recording in the form of a partogragh.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Length of the third stage of labor. Timepoint: After completing the third stage of labor. Method of measurement: Observe and determine the time using the clock and record in the partograph.</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 Deputy of Tabriz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-09-23</approval_date>
        <contact_name>Ethics committee of Tabriz University of Medical Sciences</contact_name>
        <contact_address>Research department, third floor, central construction number 2, Tabriz University of Medical Sciences, Golgasht Street, Azadi street, Tabriz, and East Azerbaijan Tabriz  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
