Epidemiology of Abnormal Vaginal Discharge During Pregnancy

Vaginal Infection Clinical Trial

Official title:

Epidemiology and Clinico-investigative Study of Abnormal Vaginal Discharge During Pregnancy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04719754
• Other study ID #: VD-WHH
• Status: Recruiting
• Start date: June 1, 2021
• Est. completion date: December 2022

Study information

• Verified date: January 2021
• Source: Assiut University
• Contact: Doaa Makarem, MSc
• Phone: +201065312287
• Email: Doaamakarem5[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 164
• Est. completion date: December 2022
• Est. primary completion date: October 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 19 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Vaginal Discharge
• Vaginal Infection

Intervention

Diagnostic Test:
• Vaginal swab
The other vaginal swab will be cultured on blood agar, chocolate agar, MacConkey agar and Sabourauds dextrose agar. The cultures will be incubated at 37ºC for 24-96 h or until the colonies appear.

Locations

Country	Name	City	State
Egypt	Woman's Health Hospital - Assiut university	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The prevalence of microorganism in the vaginal discharge during pregnancy.		9 months