CClinicalTrials.gg
Status unknownNCT04719754Updated Jan 22, 2021

Epidemiology of Abnormal Vaginal Discharge During Pregnancy

An observational study in Vaginal Infection, sponsored by Assiut University. Status unknown at 1 site in Egypt. Open to female participants aged 19 Years to 40 Years. Per ClinicalTrials.gov, last updated 2021-01-22.

Sponsored by Assiut University · Observational

The sponsor has not verified this record recently (last verified Jan 2021), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
164
Ages
19 Years to 40 Years
Sex
Female
01

Study 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.

02

Conditions studied

  • Vaginal Infection
03

In context

Lead sponsor

Assiut University is the lead sponsor of 4,901 studies on the registry; 2,098 are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years to 40 Years
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Pregnant women

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
164 participants (estimated)
Patient registry
No

Groups and cohorts

  • Pregnant women with abnormal vaginal discharge

    Diagnostic Test: Vaginal swab

  • Pregnant women without abnormal vaginal discharge

    Diagnostic Test: Vaginal swab

Interventions

  • Diagnostic testVaginal 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.

06

What researchers measure

Primary outcomes

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

    Time frame: 9 months

07

Study locations

1 of 1 sites recruiting
  • Woman's Health Hospital - Assiut university
    Assiut, 71111, Egypt
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 22, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04719754
Lead sponsor
Assiut University
Responsible party
Doaa Makarem Hassan (Resident, Assiut University) — Principal investigator
First posted
Jan 22, 2021
Start date
Jun 1, 2021 (estimated)
Primary completion
Oct 2022 (estimated)
Completion
Dec 2022 (estimated)
Last update
Jan 22, 2021

Study contacts

Doaa Makarem, MSc
Contact
Doaamakarem5@gmail.com
+201065312287
Ahmed Alaa Youssef, MD
Contact
ahmedalaa11282@yahoo.com
01006184921
Ahmed K Ibrahim, MD
study director · Woman's Health Hospital- Assiut university

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.

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