<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04419961</url>
  </required_header>
  <id_info>
    <org_study_id>PSD20</org_study_id>
    <nct_id>NCT04419961</nct_id>
  </id_info>
  <brief_title>Sexual Dysfunction and an Educational Program to Improve the Quality of Sexual Function in Vietnamese Pregnant Women in First Trimester</brief_title>
  <official_title>Sexual Dysfunction and an Educational Program to Improve the Quality of Sexual Function in Vietnamese Pregnant Women in First Trimester</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Hospital of Obstetrics and Gynecology</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National Hospital of Obstetrics and Gynecology</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Sexual dysfunction is common in pregnant women (46.6%, 34.4%, and 73.3% in women in the&#xD;
      first, second, and third trimester worldwide, respectively). These dysfunctions can persist&#xD;
      after childbirth, affecting quality of life, marriage satisfaction, and family happiness. In&#xD;
      Vietnam, a country heavily influenced by the Eastern traditions, sexual activity is&#xD;
      considered private and only shared between husband and wife. Many women have wrong beliefs&#xD;
      that having sexual intercouse during pregnancy will affect the safety of the fetus, and thus,&#xD;
      are reluctant to engage in sexual activity with their husband. Interventions have been&#xD;
      developed to improve the quality of sexual function in pregnant women.&#xD;
&#xD;
      In Vietnam, data of sexual dysfunction in pregnant women are somewhat limited, and there have&#xD;
      been no programs to improve the sexual function for this population. Therefore, the study&#xD;
      team plans to develop an educational program with aim to improve the quality of sexual&#xD;
      function in Vietnamese pregnant women. This study aims to investigate the prevalence and&#xD;
      associated factors of sexual dysfunction in first-trimester pregnant women and evaluate the&#xD;
      effectiveness of the educational program.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">September 15, 2020</start_date>
  <completion_date type="Anticipated">December 1, 2021</completion_date>
  <primary_completion_date type="Anticipated">October 1, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Prevalence of sexual dysfunction in pregnant women</measure>
    <time_frame>Baseline</time_frame>
    <description>Sexual function is evaluated using the Female Sexual Function Index (FSFI). The FSFI includes 19 questions covering six domains: desire, arousal, lubrication, orgasm, satisfaction, and pain. Questions ask about participant's sexual experience during the past four weeks, rating the degree/frequency of their experience on a scale from &quot;not at all&quot; or &quot;never&quot; to &quot;very&quot; or &quot;always&quot;. Four questions score 1-5 and fifteen score 0-5. Then, the scores of questions in an individual domain are added and the total score is multiplied by the domain factor. Finally, the six domain scores are added to obtain the full scale score. A total FSFI score of &lt;= 26.55 is considered sexual dysfunction.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in the FSFI score from baseline to two months</measure>
    <time_frame>Two months</time_frame>
    <description>Patients are followed up after two months and repeated the FSFI. The difference between the baseline total FSFI score and the two-month total FSFI score is calculated. The mean difference is calculated for the intervention and the control arm.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in knowledge and attitude at two months</measure>
    <time_frame>Two months</time_frame>
    <description>Knowledge and attitude are assessed by asking participants whether they agree or disagree with 24 statements. These statements are developed based on the key messages of the educational program. K/A assessment is repeated at two months. We calculate the proportion of participants who have changes in knowledge and attitude after the educational program.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">350</enrollment>
  <condition>Female Sexual Dysfunction</condition>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Routine care.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Routine care plus participation in an educational program including a group discussion and a booklet.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Educational program</intervention_name>
    <description>The educational program includes a group discussion and a booklet.&#xD;
The group discussion lasts for 90 minutes, discussing importance of sexual activity during pregnancy, improving sexual experience during pregnancy, physical and mental changes of pregnant women, and measures to cope with discomfort, anxiety, fear and other issues. It includes a 30-minutes presentation, followed by 1-hour discussion.&#xD;
The booklet is a color-printed A5-size booklet containing in-depth information of the content given during the discussion. Each participant can only receive one copy of the booklet, and the booklet is not given to the control participants.</description>
    <arm_group_label>Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Pregnant women whose gestational age is less than or equal to 12 weeks.&#xD;
&#xD;
          -  Currently living with husband/partner.&#xD;
&#xD;
          -  No signs and symptoms of first trimester complications (eg, threated abortion).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Getting pregnant from in vitro fertilization or having a history of preterm birth.&#xD;
&#xD;
          -  Having serious health conditions that require abortion.&#xD;
&#xD;
          -  Illiterate, or having mental illness or incapacity.&#xD;
&#xD;
          -  Having a fetus diagnosed with anomalies.&#xD;
&#xD;
          -  Does not agree to participate.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Thanh C Phan, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>National Hospital of Obstetrics and Gynecology</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Thanh C Phan, MD</last_name>
    <phone>+84948226044</phone>
    <email>drthanh.nhog@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>National Hospital of Obstetrics and Gynecology</name>
      <address>
        <city>Hanoi</city>
        <country>Vietnam</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Thanh Phan, MD</last_name>
      <email>drthanh.nhog@gmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Vietnam</country>
  </location_countries>
  <verification_date>August 2021</verification_date>
  <study_first_submitted>June 3, 2020</study_first_submitted>
  <study_first_submitted_qc>June 3, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 9, 2020</study_first_posted>
  <last_update_submitted>August 30, 2021</last_update_submitted>
  <last_update_submitted_qc>August 30, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 1, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>National Hospital of Obstetrics and Gynecology</investigator_affiliation>
    <investigator_full_name>PHAN CHI PHAN</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>sexual dysfunction</keyword>
  <keyword>pregnant women</keyword>
  <keyword>education</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04419961
org study id: PSD20
nct id: NCT04419961
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Sexual dysfunction is common in pregnant women (46.6%, 34.4%, and 73.3% in women in the
      first, second, and third trimester worldwide, respectively). These dysfunctions can persist
      after childbirth, affecting quality of life, marriage satisfaction, and family happiness. In
      Vietnam, a country heavily influenced by the Eastern traditions, sexual activity is
      considered private and only shared between husband and wife. Many women have wrong beliefs
      that having sexual intercouse during pregnancy will affect the safety of the fetus, and thus,
      are reluctant to engage in sexual activity with their husband. Interventions have been
      developed to improve the quality of sexual function in pregnant women.

      In Vietnam, data of sexual dysfunction in pregnant women are somewhat limited, and there have
      been no programs to improve the sexual function for this population. Therefore, the study
      team plans to develop an educational program with aim to improve the quality of sexual
      function in Vietnamese pregnant women. This study aims to investigate the prevalence and
      associated factors of sexual dysfunction in first-trimester pregnant women and evaluate the
      effectiveness of the educational program.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Prevalence of sexual dysfunction in pregnant women
time frame: Baseline
description: Sexual function is evaluated using the Female Sexual Function Index (FSFI). The FSFI includes 19 questions covering six domains: desire, arousal, lubrication, orgasm, satisfaction, and pain. Questions ask about participant's sexual experience during the past four weeks, rating the degree/frequency of their experience on a scale from "not at all" or "never" to "very" or "always". Four questions score 1-5 and fifteen score 0-5. Then, the scores of questions in an individual domain are added and the total score is multiplied by the domain factor. Finally, the six domain scores are added to obtain the full scale score. A total FSFI score of <= 26.55 is considered sexual dysfunction.
measure: Change in the FSFI score from baseline to two months
time frame: Two months
description: Patients are followed up after two months and repeated the FSFI. The difference between the baseline total FSFI score and the two-month total FSFI score is calculated. The mean difference is calculated for the intervention and the control arm.
measure: Change in knowledge and attitude at two months
time frame: Two months
description: Knowledge and attitude are assessed by asking participants whether they agree or disagree with 24 statements. These statements are developed based on the key messages of the educational program. K/A assessment is repeated at two months. We calculate the proportion of participants who have changes in knowledge and attitude after the educational program.
arm group label: Control
arm group type: No Intervention
description: Routine care.
arm group label: Intervention
arm group type: Experimental
description: Routine care plus participation in an educational program including a group discussion and a booklet.
intervention type: Behavioral
intervention name: Educational program
description: The educational program includes a group discussion and a booklet.
The group discussion lasts for 90 minutes, discussing importance of sexual activity during pregnancy, improving sexual experience during pregnancy, physical and mental changes of pregnant women, and measures to cope with discomfort, anxiety, fear and other issues. It includes a 30-minutes presentation, followed by 1-hour discussion.
The booklet is a color-printed A5-size booklet containing in-depth information of the content given during the discussion. Each participant can only receive one copy of the booklet, and the booklet is not given to the control participants.
arm group label: Intervention
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: No
last name: Thanh C Phan, MD
role: Principal Investigator
affiliation: National Hospital of Obstetrics and Gynecology
last name: Thanh C Phan, MD
phone: +84948226044
email: drthanh.nhog@gmail.com
facility: 
status: Recruiting
contact: 
country: Vietnam
responsible party type: Principal Investigator
investigator affiliation: National Hospital of Obstetrics and Gynecology
investigator full name: PHAN CHI PHAN
investigator title: Principal Investigator
sharing ipd: No