Epidemiology of Abnormal Vaginal Discharge During Pregnancy

NCT04719754 | Unknown

• 1 other identifier: VD-WHH
• Study Type: observational
• Target: 164
• Locations: 1 country
• Sites: 1

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.

Conditions

Vaginal Infection

Outcome Measures

Primary Outcomes (1)

• The prevalence of microorganism in the vaginal discharge during pregnancy.

  9 months

Study Arms (2)

Pregnant women with abnormal vaginal discharge

Diagnostic Test: Vaginal swab

Pregnant women without abnormal vaginal discharge

Diagnostic Test: Vaginal swab

Interventions

Vaginal swab DIAGNOSTIC_TEST

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.

Pregnant women with abnormal vaginal discharge; Pregnant women without abnormal vaginal discharge

Eligibility Criteria

• Age: 19 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Pregnant women

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Woman's Health Hospital - Assiut university

Asyut, 71111, Egypt

RECRUITING

MeSH Terms

Conditions

Vaginitis

Condition Hierarchy (Ancestors)

Vaginal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Ahmed K Ibrahim, MD

  Woman's Health Hospital- Assiut university

  STUDY DIRECTOR

Central Study Contacts

Doaa Makarem, MSc

CONTACT

+201065312287; Doaamakarem5@gmail.com

Ahmed Alaa Youssef, MD

CONTACT

01006184921; ahmedalaa11282@yahoo.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident

Study Record Dates

• First Submitted: January 18, 2021
• First Posted: January 22, 2021
• Study Start: June 1, 2021
• Primary Completion: October 1, 2022
• Study Completion: December 1, 2022
• Last Updated: January 22, 2021

Record last verified: 2021-01

Locations

EG (1)