Epidemiology of Abnormal Vaginal Discharge During Pregnancy

• Conditions: Vaginal Infection
• Interventions: Diagnostic Test: Vaginal swab

• Registration Number: NCT04719754
• Lead Sponsor: Assiut University

Brief Summary

Vaginitis among women of childbearing age is well acknowledged as a public health concern due to its high occurrence. Vulvovaginitis is a disorder of the vulva and/or vagina caused by infection, inflammation, or changes in the flora.

There are many types of infections that affect the vagina, the most common three types of infection: bacterial vaginosis, trichomoniasis, and candidiasis. Bacterial vaginosis is the most common vaginal infection in women of reproductive age causing thin and milky vaginal discharge with a fishy odor. Trichomoniasis causes a frothy, greenish-yellow discharge with a foul smell.

Vaginal Candidiasis is one of the most common fungal infections of the female genital tract and the second most common vaginal infection affecting women of reproductive age (after the bacterial infection worldwide. It affects more than 75% of women at least once in their lifetime, with approximately 50% of them also suffering a single recurrence.

About 75% of patients suffering from candidiasis are asymptomatic, but it may be symptomatic with clinical picture characterized by itching, vaginal pain, vulvar burning sensation, dyspareunia, dysuria and mildly unpleasant odor, erythema and vulvar edema, white-yellowish plaques on the walls of the vagina and cervix and cheesy vaginal discharge. The risk of vulvo-vaginal candidiasis increases by 30% during pregnancy also in pregnancy, the presence of vaginitis is related to abortion, intrauterine infection, fetal growth retardation, premature rupture of membranes, preterm birth, low birth weight, puerperal infection, and other adverse pregnancy outcomes.

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-01
• Study First Submitted: 2021-01-18
• Study First Submitted QC: 2021-01-18
• Last Update Submitted: 2021-01-18
• Study First Posted: 2021-01-22
• Last Update Posted: 2021-01-22
• Study Start: 2021-06-01
• Primary Completion: 2022-10
• Study Completion: 2022-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 164

Inclusion Criteria

• At any gestational age
• Age of patient: 19-40

Exclusion Criteria

• Women in labor
• Women with current vaginal bleeding
• Women with current preterm rupture of membrane
• Women immunocompromised women
• Women patients who refused to participate in the study

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Pregnant women without abnormal vaginal discharge	Vaginal swab	-
Pregnant women with abnormal vaginal discharge	Vaginal swab	-

Primary Outcome Measures

Name	Time	Method
The prevalence of microorganism in the vaginal discharge during pregnancy.	9 months

Trial Locations

Locations (1)

Woman's Health Hospital - Assiut university; 🇪🇬 Assiut, Egypt