<?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>IRCT20251229068486N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2026-02-15</date_registration>
      <primary_sponsor>Ahvaz University of Medical Sciences</primary_sponsor>
      <public_title>effectiveness of maternal Forward-Leaning Positions  on rotation of posterior fetal occipital position and Maternal and Neonatal Outcomes</public_title>
      <acronym>OP- occiput posterior</acronym>
      <scientific_title>Evaluation of the effectiveness of maternal  Forward-Leaning Positions during labor on rotation of posterior fetal occipital position  and Maternal and Neonatal Outcomes</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2026-04-04</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>208</target_size>
      <recruitment_status>Recruiting</recruitment_status>
      <url>https://irct.ir/trial/88720</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Other design features: The forward-leaning position involves the mother standing, on hands-and-knees, or leaning forward over a table, chair, or birthing ball, so that her body weight shifts forward and the pelvis is positioned to facilitate correction of the fetal head. The mother remains in this position during the active phase of labor, with free movement of arms and legs allowed, Randomization description: 27 blocks will be used. In each block of 4, 2 people will be assigned to the intervention group and 3 people to the control group, which will be arranged randomly. Thus, at the end of each block, there will be two balancing groups.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Normal Delivery Manangment.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: The intervention group, in addition to routine midwifery care (examination, vital signs, and fetal heart rate monitoring), will assume forward-leaning positions alternately for 15–20 minutes per hour during the active phase of labor. Forward-leaning includes standing, hands-and-knees, or leaning over a table, chair, or birthing ball to shift weight forward and align the pelvis for fetal head correction, with free movement of arms and legs. Intervention 2: The control group will receive routine care.</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is There are currently no plans to publish it.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Masoumeh Khabazkhoub</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Farvardin Street, Golestan</address>
        <city>Ahvaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6135715794</zip>
        <telephone>+98 61 4224 4134</telephone>
        <email>masomekhabaz2@gmail.com</email>
        <affiliation>Ahvaz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Mina Iravani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Farvardin Street, Golestan</address>
        <city>Ahvaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6135715794</zip>
        <telephone>+98 61 3373 8538</telephone>
        <email>minairavani2004@yahoo.com</email>
        <affiliation>Ahvaz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Maternal age between 18 and 40 years.
Term pregnancy (37–42 weeks gestation).
Singleton pregnancy.
Cephalic presentation.
Spontaneous onset of labor.
Estimated fetal weight between 2500 and 4000 grams.
Fetus in occiput posterior (OP) position on initial examination or ultrasound.
Women in active phase of labor (cervical dilation ≥4 cm).
Women with parity 1 to 3.
Maternal body mass index (BMI) between 18 and 30.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>40 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>High-risk pregnancies (preeclampsia, diabetes, maternal cardiac or respiratory disease).
History of previous cesarean delivery.
Presence of severe vaginal bleeding in the mother.
Maternal contraindication to movement during labor.
Indication for labor induction.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>O80</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Vaginal delivery</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: The intervention group, in addition to routine midwifery care (examination, vital signs, and fetal heart rate monitoring), will assume forward-leaning positions alternately for 15–20 minutes per hour during the active phase of labor. Forward-leaning includes standing, hands-and-knees, or leaning over a table, chair, or birthing ball to shift weight forward and align the pelvis for fetal head correction, with free movement of arms and legs.</i_keyword>
      <i_keyword>The control group will receive routine care.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Rotation of the fetal head from posterior occiput position. Timepoint: At delivery. Method of measurement: Observation and record in check list.</prim_outcome>
      <prim_outcome>Type of delivery. Timepoint: After delivery. Method of measurement: Observation and record in check list.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Duration of active phase and second stage of labor. Timepoint: Cervix dilatation from 4 centimeter to 10 centimeter for active phase of labor and cervix dilatation from 10 centimeter to delivery of newborn for second stage of labor. Method of measurement: Clinical examination/ Measurement by digital chronometer / record in check list.</sec_outcome>
      <sec_outcome>Apgar score. Timepoint: At 1 and 5 minutes after birth. Method of measurement: Observation and examination.</sec_outcome>
      <sec_outcome>Mother satisfaction from delivery. Timepoint: After delivery. Method of measurement: Asking the mother and record in check list.</sec_outcome>
      <sec_outcome>Frequency use of episiotomy. Timepoint: After delivery. Method of measurement: Observation and record in check list.</sec_outcome>
      <sec_outcome>Labor Pain intensity. Timepoint: Measurement severity of pain for dilatation of 4; 6; 8 and 10 centimeter and second stage. Method of measurement: By visual analog scale.</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>2026-01-10</approval_date>
        <contact_name>Ahvaz Jundishapur University of Medical Sciences</contact_name>
        <contact_address>Farvardin Street, Golestan Ahvaz Khouzestan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
