<?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>IRCT20190924044873N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-01-12</date_registration>
      <primary_sponsor>Sanandaj University of Medical Sciences</primary_sponsor>
      <public_title>Comparison the effect of oral consumption of Date syrup with Honey Saffron syrup on progress of delivery</public_title>
      <acronym></acronym>
      <scientific_title>Comparison the effect of oral consumption of Date syrup with Honey Saffron syrup on progress of delivery in primiparous women</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-11-01</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>180</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/42486</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: Persons will be divided in to Honey Saffron syrup group, Palm syrup group and  Control group according to simple randomization and envelopes. Participants will be given three envelopes in the package and selected by each of them to be placed in the respective group. It should be noted that it will be written in three envelopes of the group type ( Saffron syrup, Date palm syrup and Control group).</study_design>
      <phase>3</phase>
      <hc_freetext>Progress of delivery.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Honey saffron syrup group: Honey saffron syrup is made by Kurdistan Shafa medicine company. 250 ml of saffron and 2/5 teaspoons of honey from one of the prestigious factories ( for all sample of the same type) in 150 ml of maxed water are used.                             The syrup are made in opaque glass.The presentation of syrups at begining of the study (4 cm dilatation) and then every 30 to 60 minutes is extended once thr acrive phase of the first phase of labor is delivered as the patient wishes. Intervention 2: Intervention group: Date syrup group: Date syrup is made by Kurdistan Shafa medicine company.Thus, to prepare it, 6 Bam black dates (same weight for all samples) after extracting the core in the blender thoroughly mix and then pass through the filter and completely smooth and without scrubbing mixed in 150. Intervention 3: Control group: Routine care is done.</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:
All data is shared after anonymization.

When:
The access period beings 6 months after the results are published.

To whom:
Data will be available only to researchers working in academic and research institutions.

Conditions:
Access to data requires compliance with professional ethics.

Where to obtain:
Applicants can refer to the library of the School of Nutsing and Midwifery Kurdistan University of Medical Sciences or Dr. Roonak Shaoei for information.
Address:Kurdistan University of Medical Sciences.
Email:Rshaho@yahoo.com
tel:087-33627636

How to obtain:
The applicant can access the documents after the article is published.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Roonak Shahoei</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Sanandaj, Psdaran Street, Kurdistan University of Medical Sciences</address>
        <city>Sanandaj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6617913448</zip>
        <telephone>0089 87 33627636</telephone>
        <email>Rshaho@yahoo.com</email>
        <affiliation>Sanandaj University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Roonak Shahoei</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Sanandaj, Pasdaran Street, Kurdistan University of Medical Sciences</address>
        <city>Sanandaj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6617913448</zip>
        <telephone>+98 87 3362 7636</telephone>
        <email>Rshaho@yahoo.com</email>
        <affiliation>Sanandaj University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Willingness to cooperate
Cervical dilatation 4 cm when entering the study
Age between 18-35
Single pregnancy with cephalic presentation
Gestational age between 37-42 weeks
Estimated fetal weight between 2500-4000 gr
No indication of cesarean section
Absence of fetal distress
No rupture of the membrane when entering the study
Lack of known systemic diseases
No pregnancy complication such as preeclampsia, bleeding and infection
Having no history of infertility
Having physiological labor and delivery conditions
Have physical and mental health
No sensitivity to Dates, Honey and Saffron</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>35 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Unwillingness to continue collaborating in the study process
Entering labor and nonphysiological conditions
Precipitous labor
Use of epidural anesthesia
Fetus distress
Meconium disposal
Nausea and vomiting</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>Prevention</i_code>
      <i_code>Prevention</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Honey saffron syrup group: Honey saffron syrup is made by Kurdistan Shafa medicine company. 250 ml of saffron and 2/5 teaspoons of honey from one of the prestigious factories ( for all sample of the same type) in 150 ml of maxed water are used.                             The syrup are made in opaque glass.The presentation of syrups at begining of the study (4 cm dilatation) and then every 30 to 60 minutes is extended once thr acrive phase of the first phase of labor is delivered as the patient wishes.</i_keyword>
      <i_keyword>Intervention group: Date syrup group: Date syrup is made by Kurdistan Shafa medicine company.Thus, to prepare it, 6 Bam black dates (same weight for all samples) after extracting the core in the blender thoroughly mix and then pass through the filter and completely smooth and without scrubbing mixed in 150.</i_keyword>
      <i_keyword>Control group: Routine care is done.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Progress of childbirth. Timepoint: Vaginal examinations will be done at baseline and then in the active phase of the first phase of the labor every 2 hours and in the second phase of the labor every 30 minutes. The recording of uterine contractions and fetal heart rate at baseline will be active every 30 minutes in the first phase of labor and every 15 minutes in the second phase. Method of measurement: Partograph form.</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>Sanandaj University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-10-01</approval_date>
        <contact_name>Ethics committee of Kurdistan University of Medical Sciences.</contact_name>
        <contact_address>Sanandaj.Pasdaran Street. Kurdistan University of Medical Sciences. School of Nursing and Midwifery. Sanandaj Kurdistan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
