Female Sexual DysfunctionNCT04419961
Sexual Dysfunction and an Educational Program to Improve the Quality of Sexual Function in Vietnamese Pregnant Women in First Trimester
A study testing Educational program in people with Female Sexual Dysfunction, run by National Hospital of Obstetrics and Gynecology at 1 site in Vietnam.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Female Sexual Dysfunction
- What is being tested?
- Educational program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 350 participants
- Where
- 1 siteVietnam
- Study dates
- 15 Sep 2020to 1 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Vietnam1 site, 1 recruiting
- Recruiting
National Hospital of Obstetrics and Gynecology
Hanoi
Thanh Phan, MD, drthanh.nhog@gmail.com
About this study
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.
- Conditions
- Female Sexual Dysfunction
- Being tested
- Educational program
- Keywords
- sexual dysfunction, pregnant women, education
- Medical subject headings
- Sexual Dysfunction, Physiological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational programBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Routine care. |
| Intervention | Experimental | Routine care plus participation in an educational program including a group discussion and a booklet. Receives: Behavioral: Educational program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of sexual dysfunction in pregnant women
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.
Measured: Baseline
Change in the FSFI score from baseline to 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.
Measured: Two months
Secondary outcomes (1)
Change in knowledge and attitude at 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.
Measured: Two months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2020
- Study start15 Sep 2020
- Primary completion1 Oct 2021 (estimated)
- Study completion1 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Female Sexual DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Hospital of Obstetrics and Gynecology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, PHAN CHI PHAN, National Hospital of Obstetrics and Gynecology
- Investigators
- Thanh C Phan, MD, Principal investigator, National Hospital of Obstetrics and Gynecology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04419961
- Sponsor's protocol ID
- PSD20
- Status last verified
- Aug 2021
- First submitted
- 3 Jun 2020
- Last updated
- 1 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sexual Dysfunction and an Educational Program to Improve the Quality of Sexual Function in Vietnamese Pregnant Women in First Trimester
- ClinicalTrials.gov ID
- NCT04419961
- Acronym / sponsor ID
- PSD20
- Conditions
- Female Sexual Dysfunction
- Keywords
- sexual dysfunction, pregnant women, education
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- National Hospital of Obstetrics and GynecologyUniversity, hospital or other
- Study start
- 15 Sep 2020 (actual)
- Primary completion
- 1 Oct 2021 (estimated)
- Study completion
- 1 Dec 2021 (estimated)
- First posted
- 9 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Routine care. |
| Intervention | Experimental | Behavioral: Educational programRoutine care plus participation in an educational program including a group discussion and a booklet. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Educational programThe 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. | Behavioural | Intervention |
Primary outcome
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.
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.
1 secondary outcome
Change in knowledge and attitude at two months
Time frame: Two months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thanh C Phan, MD principal investigator
National Hospital of Obstetrics and Gynecology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Educational program in people with Female Sexual Dysfunction, run by National Hospital of Obstetrics and Gynecology at 1 site in Vietnam.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Thanh C Phan, MD (+84948226044, drthanh.nhog@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of sexual dysfunction in pregnant women (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2021; AzTrials last refreshed its copy on 27 Oct 2026.