Epidemiology of Abnormal Vaginal Discharge During Pregnancy

NCT ID: NCT04719754

Last Updated: 2021-01-22

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

Total Enrollment

164 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-06-01

Study Completion Date

2022-12-31

Brief Summary

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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

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Conditions

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Vaginal Infection

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Pregnant women with abnormal vaginal discharge

Vaginal swab

Intervention Type 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 without abnormal vaginal discharge

Vaginal swab

Intervention Type 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.

Interventions

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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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Doaa Makarem Hassan

Resident

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ahmed K Ibrahim, MD

Role: STUDY_DIRECTOR

Woman's Health Hospital- Assiut university

Locations

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Woman's Health Hospital - Assiut university

Asyut, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Doaa Makarem, MSc

Role: CONTACT

+201065312287

Ahmed Alaa Youssef, MD

Role: CONTACT

01006184921

Facility Contacts

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Doaa K Makarem, MSc

Role: primary

+01065312287

Other Identifiers

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VD-WHH

Identifier Type: -

Identifier Source: org_study_id

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