- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03777371
Anti-HIV False Positivity Rate in Pregnant Women; and Investigating the Factors Affecting This Situation
December 13, 2018 updated by: Pınar Yalcin bahat, Kanuni Sultan Suleyman Training and Research Hospital
HIV virus is an etiologic agent of ( AIDS ) immunodeficiency syndrome .
It is known that the estimated rate of transfer from mother to baby is 25% to 45%, pregnancy rate is 5-10%, pregnancy rate is 15-20% and in lactation period is 5-10%.
Risk factors; maternal viral load, breastfeeding, vaginal birth, and prematurity.
Although there is a high rate of false positivity in prenatal screening in our country, one of the factors affecting this is the number of pregnancies.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
128
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Sampling Method
Probability Sample
Study Population
Pregnant women between 8 and 40 weeks of gestation
Description
Inclusion Criteria:
- Anti HIV seropositive Pregnant Women
Exclusion Criteria:
- Anti HIV seronegative Pregnant Women
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Other
- Time Perspectives: Retrospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The effect of the number of pregnancies on Anti HIV false positivity rate
Time Frame: 5 years
|
5 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2014
Primary Completion (Actual)
December 1, 2018
Study Completion (Actual)
December 1, 2018
Study Registration Dates
First Submitted
December 13, 2018
First Submitted That Met QC Criteria
December 13, 2018
First Posted (Actual)
December 17, 2018
Study Record Updates
Last Update Posted (Actual)
December 17, 2018
Last Update Submitted That Met QC Criteria
December 13, 2018
Last Verified
December 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Sexually Transmitted Diseases, Viral
- Sexually Transmitted Diseases
- Lentivirus Infections
- Retroviridae Infections
- Immune System Diseases
- Slow Virus Diseases
- HIV Infections
- Acquired Immunodeficiency Syndrome
- HIV Seropositivity
- Immunologic Deficiency Syndromes
Other Study ID Numbers
- HIVinPregnancies
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Yes
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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