Epidemiology of Abnormal Vaginal Discharge During Pregnancy

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

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.

Study Overview

• Status: Unknown
• Conditions: Vaginal Infection
• Intervention / Treatment: Diagnostic test: Vaginal swab

• Study Type: Observational
• Enrollment (Anticipated): 164

Contacts and Locations

• Study Contact: Name: Doaa Makarem, MSc; Phone Number: +201065312287; Email: Doaamakarem5@gmail.com
• Study Contact Backup: Name: Ahmed Alaa Youssef, MD; Phone Number: 01006184921; Email: ahmedalaa11282@yahoo.com

Study Locations

• Egypt
  • Assiut, Egypt, 71111
    • Recruiting
    • Woman's Health Hospital - Assiut university
    • Contact: Doaa K Makarem, MSc; Phone Number: +01065312287; Email: Doaamakarem5@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Pregnant women

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Pregnant women with abnormal vaginal discharge	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.
Pregnant women without abnormal vaginal discharge	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The prevalence of microorganism in the vaginal discharge during pregnancy.	9 months

Collaborators and Investigators

• Sponsor: Assiut University
• Investigators: Study Director: Ahmed K Ibrahim, MD, Woman's Health Hospital- Assiut university

Study record dates

Study Major Dates

• Study Start (Anticipated): June 1, 2021
• Primary Completion (Anticipated): October 1, 2022
• Study Completion (Anticipated): December 1, 2022

Study Registration Dates

• First Submitted: January 18, 2021
• First Submitted That Met QC Criteria: January 18, 2021
• First Posted (Actual): January 22, 2021

Study Record Updates

• Last Update Posted (Actual): January 22, 2021
• Last Update Submitted That Met QC Criteria: January 18, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vaginal Diseases; Vaginal Discharge
• Other Study ID Numbers: VD-WHH

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No