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

NCT ID: NCT04419961

Last Updated: 2021-09-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

350 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-15

Study Completion Date

2021-12-01

Brief Summary

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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.

Detailed Description

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Conditions

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Female Sexual Dysfunction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Control

Routine care.

Group Type NO_INTERVENTION

No interventions assigned to this group

Intervention

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

Group Type EXPERIMENTAL

Educational program

Intervention Type 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.

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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National Hospital of Obstetrics and Gynecology

OTHER

Sponsor Role lead

Responsible Party

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PHAN CHI PHAN

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Thanh C Phan, MD

Role: PRINCIPAL_INVESTIGATOR

National Hospital of Obstetrics and Gynecology

Locations

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National Hospital of Obstetrics and Gynecology

Hanoi, , Vietnam

Site Status RECRUITING

Countries

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Vietnam

Central Contacts

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Thanh C Phan, MD

Role: CONTACT

+84948226044

Facility Contacts

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Thanh Phan, MD

Role: primary

Other Identifiers

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PSD20

Identifier Type: -

Identifier Source: org_study_id

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