Postpartum PeriodNCT00001867
Effect of Pregnancy on Uveitis
An observational study of Postpartum Period and Pregnancy, run by National Eye Institute (NEI) at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Postpartum Period, Pregnancy, Uveitis
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 1999to Sep 2000
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
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.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Eye Institute (NEI)
Bethesda, Maryland, 20892
About this study
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.
Read the detailed description
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.
- Conditions
- Postpartum Period, Pregnancy, Uveitis
- Keywords
- Cytokine, Gestation, Postpartum, Pregnancy, Th 1 Lymphocyte, Th 2 Lymphocyte, Uveitis
- Medical subject headings
- Uveitis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2002 (estimated)
- Study startSep 1999
- Study completionSep 2000
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Postpartum PeriodStudies of the same condition, open and under way.
- 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
- Enrolment
- 10 participants
Sponsor and investigators
- Lead sponsor
- National Eye Institute (NEI)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00001867
- Sponsor's protocol ID
- 990179
- Other IDs
- 99-EI-0179
- Status last verified
- Sep 1999
- First submitted
- 3 Nov 1999
- Last updated
- 4 Mar 2008
- Results posted
- No
Publications
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.
PubMed 8363725Raghupathy 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.
PubMed 9357139Raghupathy 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.
PubMed 9228305
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Pregnancy on Uveitis
- ClinicalTrials.gov ID
- NCT00001867
- Acronym / sponsor ID
- 990179
- Conditions
- Postpartum Period, Pregnancy, Uveitis
- Keywords
- Cytokine, Gestation, Postpartum, Pregnancy, Th 1 Lymphocyte, Th 2 Lymphocyte, Uveitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants
- Lead sponsor
- National Eye Institute (NEI)US National Institutes of Health
- Study start
- Sep 1999
- Study completion
- Sep 2000
- First posted
- 10 Dec 2002 (estimated)
- 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.
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.
Detailed description
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.
Study design
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2008.
- Background: PubMed 8363725Wegmann 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.
- Background: PubMed 9357139Raghupathy 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.
- Background: PubMed 9228305Raghupathy 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.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Postpartum Period and Pregnancy, run by National Eye Institute (NEI) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2008. 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00001867, which also lists 3 linked publications.
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 4 Mar 2008.