<?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>IRCT20260805070545N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2026-08-27</date_registration>
      <primary_sponsor>Ahvaz University of Medical Sciences</primary_sponsor>
      <public_title>Effect of second stage of labor management program on pelvic floor muscle</public_title>
      <acronym></acronym>
      <scientific_title>Design, Implementation, and Evaluation of the Impact of a Second-Stage Labor Management Program on Pelvic Floor Muscle Health: A Mixed-Methods Evaluation Design</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2026-09-06</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>420</target_size>
      <recruitment_status>Recruiting</recruitment_status>
      <url>https://irct.ir/trial/92492</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Midwives are divided into two intervention and control groups with a 1:1 allocation ratio using stratified randomization based on the variable of work experience (less than 5 years and 5 years or more). The randomization sequence is generated by an independent person from the research team using a random number table. The final allocation is kept in opaque, sealed, and numbered envelopes and is known only to the independent person until the results are announced.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Pelvic floor disorders after vaginal delivery.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Participants in the intervention group will receive a Second Stage of Labor Management Program designed to protect pelvic floor muscle health during childbirth. The program will be implemented by trained midwives and includes evidence-based interventions during the second stage of labor, such as guidance on spontaneous pushing, appropriate maternal birthing positions, controlled breathing techniques, perineal support, controlled delivery of the fetal head, and other standardized practices aimed at reducing pelvic floor muscle strain and birth-related pelvic floor injury. Intervention 2: Control group: Participants in the control group will receive routine intrapartum care according to the standard clinical protocols of the study setting. Labor and birth management will be conducted by the attending healthcare providers without implementation of the structured Second Stage of Labor Management Program.</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:
The documentation will be published as articles on scientific websites.

When:
Access period begins 6 months after the publication of results.

To whom:
Researchers at academic and scientific institutions, students, and midwives working in public and private centers.

Conditions:
For the purpose of conducting further research or applying the results in clinical settings or scientific documentation.

Where to obtain:
Articles published on domestic and international scientific and research websites will be accessible.

How to obtain:
Scientific articles based on research findings are eligible for publication in journals following rigorous peer review.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Hadis Bahmaei</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Iran, Ahvaz, Golestan Highway, Ahvaz Jundishapur University</address>
        <city>Ahvaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۶۱۳۵۷۱۵۷۹۴</zip>
        <telephone>+98 61 3314 0000</telephone>
        <email>hadisbahmaei8894@gmail.com</email>
        <affiliation>Ahvaz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Hadis Bahmaei</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Iran, Ahvaz, Golestan Highway, Ahvaz Jundishapur University</address>
        <city>رامهرمز</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۶۱۳۵۷۱۵۷۹۴</zip>
        <telephone>+98 61 3314 0000</telephone>
        <email>hadisbahmaei8894@gmail.com</email>
        <affiliation>Ahvaz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Willingness to participate in the study
Maternal age between 18 and 45 years
Singleton live fetus
Cephalic fetal presentation
Low-risk pregnancy
Gestational age between 37 and 41 weeks of pregnancy</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>45 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Attendance at more than four childbirth preparation classes
Performing perineal massage during pregnancy
Presence of a birth companion (professional labor support midwife/doula or a family member)
high-risk pregnancy
Presence of contraindications to vaginal birth
Presence of maternal medical conditions documented in the medical record</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 - Other</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Participants in the intervention group will receive a Second Stage of Labor Management Program designed to protect pelvic floor muscle health during childbirth. The program will be implemented by trained midwives and includes evidence-based interventions during the second stage of labor, such as guidance on spontaneous pushing, appropriate maternal birthing positions, controlled breathing techniques, perineal support, controlled delivery of the fetal head, and other standardized practices aimed at reducing pelvic floor muscle strain and birth-related pelvic floor injury.</i_keyword>
      <i_keyword>Control group: Participants in the control group will receive routine intrapartum care according to the standard clinical protocols of the study setting. Labor and birth management will be conducted by the attending healthcare providers without implementation of the structured Second Stage of Labor Management Program.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pelvic floor muscle strength. Timepoint: 8–12 weeks postpartum. Method of measurement: Pelvic floor muscle strength will be assessed using the Modified Oxford Scale (MOS) through standardized digital vaginal examination performed by trained assessors. The MOS is a validated 6-point grading system ranging from 0 (no palpable contraction) to 5 (strong contraction).</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>Ahvaz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2026-08-15</approval_date>
        <contact_name>Vice Chancellor for Research and Technology, Ahvaz Jundishapur University of Medical Sciences</contact_name>
        <contact_address>Ground Floor, Vice Chancellor for Research and Technology, Ahvaz Jundishapur University of Medical Sciences, University Campus, Ahvaz, Khuzestan, Iran رامهرمز Khouzestan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
