Completed

Effect of Pregnancy on Uveitis

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What is being collected

Data Collection

Who is being recruted

Eye Diseases

+ Uveal Diseases

+ Uveitis

See all eligibility criteria
How is the trial designed

Observational
Study Start: September 1999
See protocol details

Summary

Principal SponsorNational Eye Institute (NEI)
Last updated: March 4, 2008
Sourced from a government-validated database.Claim as a partner

Study start date: September 1, 1999

Actual date on which the first participant was enrolled.

Pregnancy is thought to be associated with the remediation of some disease and exacerbation of other conditions. Anecdotal case reports suggest that uveitis may remit or improve during pregnancy and recur in the postpartum period. This observation is supported by findings in an experimental autoimmune uveitis model in mice. We propose to study the natural history of ocular inflammation in a series of pregnant women who have had ocular inflammation (uveitis) in the two year period prior to becoming pregnant. Women will be enrolled between 2 and 20 completed weeks of gestation at which time they will receive a complete ophthalmologic examination and will have blood drawn for cytokine and hormone evaluation. These procedures will be repeated at monthly intervals until 6 months postpartum. Treatment of uveitis will ensue as medically indicated and in consultation with the woman's obstetric care provider. The goal of this investigation is to determine whether cytokine levels are correlated with disease expression. Such information may be useful to inform decisions about how to best manage pregnant and postpartum uveitis patients in the future.

NCT00001867
Principal SponsorNational Eye Institute (NEI)
Last updated: March 4, 2008
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

10 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Female

Biological sex of participants that are eligible to enroll.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Eye DiseasesUveal DiseasesUveitis

Criteria

Females with a history of unilateral or bilateral immune-mediated, non-infectious inflammatory ocular disease that required topical and/or systemic immunosuppresive medications at least once in the past two years or who are currently under treatment for unilateral or bilateral non-infectious ocular inflammation and having diagnosed uveitis, scleritis, or autoimmune corneal disorders in the past two years. First and second trimester pregnancy. Informed consent from the patient. No pregnancy complications which require medical treatment and special obstetric care. No hematolgical disorder that would preclude blood draws for investigational purposes. No current ocular or systemic infection. No current malignancy. No current endocrine disorders.

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

National Eye Institute (NEI)

Bethesda, United StatesOpen National Eye Institute (NEI) in Google Maps
CompletedOne Study Center