NCT00001867

Brief Summary

The purpose of this study is to gain information about the course of uveitis (a type of eye inflammation) during pregnancy and the postpartum period (six months after delivery). Some reports have indicated the condition may improve or disappear without treatment during pregnancy and recur postpartum, requiring treatment. No systematic studies have been done, however, to examine a link between pregnancy and disease suppression. All medicines for uveitis have side effects-particularly for pregnant women, their unborn babies, and breast-feeding mothers. The information gained may help guide treatment decisions for these patients in the future. Women who are between 2 and 20 weeks pregnant and have had uveitis within 2 years of becoming pregnant will be followed monthly with an eye examination and blood tests until six months after giving birth. The eye examination will include dilation of the pupils to look at the back of the eye. Photos of the eye will be taken to record changes that occur due to uveitis. The blood tests will assess immune function and try to determine whether levels of hormones and cytokines are related to uveitis disease activity. Patients who develop an inflammation and significant vision loss may require treatment, possibly with eye drops or injections near the eye. Treatment will be decided in consultation with the patient's obstetrician.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 1999

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 1999

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 3, 1999

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2000

Completed
2.3 years until next milestone

First Posted

Study publicly available on registry

December 10, 2002

Completed
Last Updated

March 4, 2008

Status Verified

September 1, 1999

First QC Date

November 3, 1999

Last Update Submit

March 3, 2008

Conditions

Keywords

CytokineGestationPostpartumPregnancyTh 1 LymphocyteTh 2 LymphocyteUveitis

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

National Eye Institute (NEI)

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

  • Wegmann TG, Lin H, Guilbert L, Mosmann TR. Bidirectional cytokine interactions in the maternal-fetal relationship: is successful pregnancy a TH2 phenomenon? Immunol Today. 1993 Jul;14(7):353-6. doi: 10.1016/0167-5699(93)90235-D.

    PMID: 8363725BACKGROUND
  • Raghupathy R. Th1-type immunity is incompatible with successful pregnancy. Immunol Today. 1997 Oct;18(10):478-82. doi: 10.1016/s0167-5699(97)01127-4.

    PMID: 9357139BACKGROUND
  • Raghupathy R. Maternal anti-placental cell-mediated reactivity and spontaneous abortions. Am J Reprod Immunol. 1997 Jun;37(6):478-84. doi: 10.1111/j.1600-0897.1997.tb00263.x.

    PMID: 9228305BACKGROUND

MeSH Terms

Conditions

Uveitis

Condition Hierarchy (Ancestors)

Uveal DiseasesEye Diseases

Study Design

Study Type
observational
Sponsor Type
NIH

Study Record Dates

First Submitted

November 3, 1999

First Posted

December 10, 2002

Study Start

September 1, 1999

Study Completion

September 1, 2000

Last Updated

March 4, 2008

Record last verified: 1999-09

Locations