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

NCT04419961 | Unknown

• 1 other identifier: PSD20
• Study Type: interventional
• Target: 350
• Locations: 1 country
• Sites: 1

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.

Conditions

Female Sexual Dysfunction

Keywords

sexual dysfunction; pregnant women; education

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Two months

Secondary Outcomes (1)

• Change in knowledge and attitude at two months

  Two months

Study Arms (2)

Control

NO INTERVENTION

Routine care.

Intervention

EXPERIMENTAL

Routine care plus participation in an educational program including a group discussion and a booklet.

Behavioral: Educational program

Interventions

Educational program BEHAVIORAL

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.

Intervention

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Hospital of Obstetrics and Gynecology: lead

Study Sites (1)

National Hospital of Obstetrics and Gynecology

Hanoi, Vietnam

RECRUITING

MeSH Terms

Conditions

Sexual Dysfunction, Physiological

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Study Officials

• Thanh C Phan, MD

  National Hospital of Obstetrics and Gynecology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Thanh C Phan, MD

CONTACT

+84948226044; drthanh.nhog@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 3, 2020
• First Posted: June 9, 2020
• Study Start: September 15, 2020
• Primary Completion: October 1, 2021
• Study Completion: December 1, 2021
• Last Updated: September 1, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

VN (1)