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Sexual Dysfunction and an Educational Program to Improve the Quality of Sexual Function in Vietnamese Pregnant Women in First Trimester

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04419961
Recruitment Status : Not yet recruiting
First Posted : June 9, 2020
Last Update Posted : June 11, 2020
Sponsor:
Information provided by (Responsible Party):
PHAN CHI PHAN, National Hospital of Obstetrics and Gynecology

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Female Sexual Dysfunction Behavioral: Educational program Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 350 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Sexual Dysfunction and an Educational Program to Improve the Quality of Sexual Function in Vietnamese Pregnant Women in First Trimester
Estimated Study Start Date : August 15, 2020
Estimated Primary Completion Date : December 1, 2020
Estimated Study Completion Date : December 31, 2020

Arm Intervention/treatment
No Intervention: Control
Routine care.
Experimental: Intervention
Routine care plus participation in an educational program including a group discussion and a booklet.
Behavioral: Educational program

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.





Primary Outcome Measures :
  1. Prevalence of sexual dysfunction in pregnant women [ Time Frame: Baseline ]
    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.

  2. Change in the FSFI score from baseline to two months [ Time Frame: Two months ]
    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.


Secondary Outcome Measures :
  1. Change in knowledge and attitude at two months [ Time Frame: Two months ]
    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.



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Pregnant women whose gestational age is less than or equal to 12 weeks.
  • Currently living with husband/partner.
  • No signs and symptoms of first trimester complications (eg, threated abortion).

Exclusion Criteria:

  • Getting pregnant from in vitro fertilization or having a history of preterm birth.
  • Having serious health conditions that require abortion.
  • Illiterate, or having mental illness or incapacity.
  • Having a fetus diagnosed with anomalies.
  • Does not agree to participate.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04419961


Contacts
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Contact: Thanh C Phan, MD +84948226044 drthanh.nhog@gmail.com

Sponsors and Collaborators
National Hospital of Obstetrics and Gynecology
Investigators
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Principal Investigator: Thanh C Phan, MD National Hospital of Obstetrics and Gynecology
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Responsible Party: PHAN CHI PHAN, Principal Investigator, National Hospital of Obstetrics and Gynecology
ClinicalTrials.gov Identifier: NCT04419961    
Other Study ID Numbers: PSD20
First Posted: June 9, 2020    Key Record Dates
Last Update Posted: June 11, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by PHAN CHI PHAN, National Hospital of Obstetrics and Gynecology:
sexual dysfunction
pregnant women
education