Vaginal InfectionNCT04719754
Epidemiology of Abnormal Vaginal Discharge During Pregnancy
An observational study of Vaginal Infection, run by Assiut University at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Ages 19 to 40 years, women only
- Conditions the study is for
- Vaginal Infection
- What is being tested?
- Vaginal swab
- How many people
- 164 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2021to Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 40 years
- Women only
- No healthy volunteers
- Adult
Study population: Pregnant women
Who may be able to join
- At any gestational age
- Age of patient: 19-40
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Woman's Health Hospital - Assiut university
Asyut, 71111
Doaa K Makarem, MSc, +01065312287, Doaamakarem5@gmail.com
About this study
Official title: 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.
Read more
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
- Being tested
- Vaginal swab
- Medical subject headings
- Vaginitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vaginal swabDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| Pregnant women with abnormal vaginal discharge | Not described Receives: Diagnostic Test: Vaginal swab | |
| Pregnant women without abnormal vaginal discharge | Not described Receives: Diagnostic Test: Vaginal swab |
What is being measured
The primary outcome is the main question the study is designed to answer.
The prevalence of microorganism in the vaginal discharge during pregnancy.
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2021
- Study start1 Jun 2021 (estimated)
- Primary completionOct 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vaginal InfectionStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 164 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Doaa Makarem Hassan, Assiut University
- Investigators
- Ahmed K Ibrahim, MD, Study director, Woman's Health Hospital- Assiut university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04719754
- Sponsor's protocol ID
- VD-WHH
- Status last verified
- Jan 2021
- First submitted
- 18 Jan 2021
- Last updated
- 22 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidemiology and Clinico-investigative Study of Abnormal Vaginal Discharge During Pregnancy
- ClinicalTrials.gov ID
- NCT04719754
- Acronym / sponsor ID
- VD-WHH
- Conditions
- Vaginal Infection
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 164 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jun 2021 (estimated)
- Primary completion
- Oct 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 22 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pregnant women with abnormal vaginal discharge | – | Diagnostic Test: Vaginal swab |
| Pregnant women without abnormal vaginal discharge | – | Diagnostic Test: Vaginal swab |
Who may qualify
- Ages
- 19 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Pregnant women
Key inclusion criteria (2 listed)
- At any gestational age
- Age of patient: 19-40
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vaginal swabThe 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. | Diagnostic test | Pregnant women with abnormal vaginal discharge, Pregnant women without abnormal vaginal discharge |
Primary outcome
The prevalence of microorganism in the vaginal discharge during pregnancy.
Time frame: 9 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2021.
- Individual participant dataSharing planned: Undecided
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Prevention of Vaginal Cuff Infection After Hysterectomy by Addition of Vaginal Clindamycin
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Randomized, Open-label
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ahmed K Ibrahim, MD study director
Woman's Health Hospital- Assiut university
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vaginal Infection, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Doaa Makarem, MSc (+201065312287, Doaamakarem5@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The prevalence of microorganism in the vaginal discharge during pregnancy. (time frame: 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2021.