<?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>IRCT201403013706N22</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2014-04-04</date_registration>
      <primary_sponsor>Research deputy of Tabriz University of Medical Sciences</primary_sponsor>
      <public_title>The effect of a pelvic floor muscle exercise program on sexual function of women during pregnancy and after delivery</public_title>
      <acronym></acronym>
      <scientific_title>The effect of a pelvic floor muscle exercise program on sexual function of women during pregnancy and after delivery: a randomized controlled trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2014-04-10</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>84</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/3813</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Other design features: Only outcome assessor will be blinded.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Maternal diseases.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Pelvic floor exercises will be done twice a day; 8-12 set of contractions at each time, every set includes a strong contraction with a maximum possible power holding for 6-8 seconds followed by 3 or 4 contractions in shorter period, with a 10-seconds resting after each contraction. The treatment group will get practical and written education about the exercises at the recruitment day. Accuracy of the exercise performance will be checked at different positions at three about 30-minutes meetings held at 22-24, 28-30, 34-36 weeks of gestation. Also, telephone follow-up will be done weekly in the first month and every other week afterwards. Intervention 2: Control group will receive regular care  and will get education on personal hygiene and care of the newborn at one session at 28- 30 weeks of gestation.</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>Zahra Pourkhiz</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Kousar Dormitory, South Shariati Ave, Tabriz, Iran</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 15 1323 4278</telephone>
        <email>zahra.pourkhiz@yahoo.com</email>
        <affiliation>Midwifery Department, Faculty of Nursing &amp; Midwifery, Tabriz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Sakineh Mohammad-Alizadeh-Charandabi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Midwifery Department, Faculty of Nursing and Midwifery,South Shariati, Tabriz</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5138947977</zip>
        <telephone>+98 41 1477 2699</telephone>
        <email>alizades@tbzmed.ac.ir</email>
        <affiliation>Midwifery Department, Faculty of Nursing and Midwifery, Tabriz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: 1. Having a record at the health centres, 2. Having middle school or above education, 3. No history of previous delivery, 4. Having a single pregnancy, 5. Aged 18 to 35 years, 6. Gestational age of 17-20 weeks, 7. Permanent marriage and living with husband. &#13;
Exclusion criteria: 1. Addiction to drugs and alcohol, 2. History of two or more abortions, 3. Experience of severe emotional stress within the previous three months, 4. Physical or mental diseases affected on sexual function (e.g., depression, mania, limb amputation or paralysis, the phobias, vaginusmus, 5. Taking medicines affected on sexual function (including blood pressure drugs, thiazide diuretics, anti-depressants, anti-histamines, barbiturates, narcotics, Diazepines and amphetamines, cocaine), 6. History of any pregnancy-related complications limited sexual performance according physician advice (e.g., placenta previa, cervical cerclage) 7. Underlying medical diseases (cardiovascular, gastrointestinal, respiratory, epilepsy, blood pressure), 8. Pelvic floor muscle strength of Level one or less (according to the Oxford grading criteria) or hereditary disease affecting connective tissue (such as Marfan syndrome, muscular dystrophy) or maternal abnormalities in the reproductive system, 9. Having over 12 urinary incontinence episodes per day, 10. Addiction or mental or physical problems of husband affecting on couple sexual function</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>35 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>099</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Other maternal diseases classifiable elsewhere but complicating pregnancy, childbirth and the puerperium</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Pelvic floor exercises will be done twice a day; 8-12 set of contractions at each time, every set includes a strong contraction with a maximum possible power holding for 6-8 seconds followed by 3 or 4 contractions in shorter period, with a 10-seconds resting after each contraction. The treatment group will get practical and written education about the exercises at the recruitment day. Accuracy of the exercise performance will be checked at different positions at three about 30-minutes meetings held at 22-24, 28-30, 34-36 weeks of gestation. Also, telephone follow-up will be done weekly in the first month and every other week afterwards.</i_keyword>
      <i_keyword>Control group will receive regular care  and will get education on personal hygiene and care of the newborn at one session at 28- 30 weeks of gestation</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Sexual function. Timepoint: At baseline, 28-30 weeks of gestation, 3 months after delivery. Method of measurement: FSFI Questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Pelvic floor muscle strength. Timepoint: At baseline, 28-30 weeks gestation, 3 months after delivery. Method of measurement: Oxford grading system.</sec_outcome>
      <sec_outcome>Health-related Quality of Life. Timepoint: 28-30 weeks of gestation, 3 months after delivery. Method of measurement: Sf-36 questionnaire.</sec_outcome>
      <sec_outcome>Quality of sexual life. Timepoint: 28-30 weeks of pregnancy. Method of measurement: SQOL-f Questionnaire.</sec_outcome>
      <sec_outcome>Urinary Incontinence. Timepoint: 36-34 weeks of gestation, 3 months after delivery. Method of measurement: ICIQ-SF questionnaire.</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>2014-02-19</approval_date>
        <contact_name>Ethics Committee in Tabriz University of Medical Sciences</contact_name>
        <contact_address>Research Deputy, 3rd floor, Centeral building No 2, Tabriz University of Medical Sciences, Golgasht st., Tabriz, Iran Tabriz  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
