Ignite Creation Date:
2024-05-06 @ 7:28 PM
Last Modification Date:
2024-10-26 @ 3:07 PM
Study NCT ID:
NCT06021925
Status:
RECRUITING
Last Update Posted:
2024-01-24
First Post:
2023-08-25
Brief Title:
Obstetrical History and Anti-HLA Antibodies Level
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Assistance Publique - Hôpitaux de Paris
Study Overview
Official Title:
Obstetrical History and Anti-HLA Antibodies Level
Status:
RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
OBS-HLA
Brief Summary:
Chronic histiocytic intervillositis CHI is associated with severe and recurrent obstetrical complications A link between anti-HLA Antibodies Ab and CHI has recently been established At the Etablissement Français du Sang EFS donors who have already given birth once and have high levels of anti-HLA are excluded from donating apheresis platelets and therapeutic plasma to prevent TRALI Transfusion Related Acute Lung Injury No studies have examined the obstetrical history of these donors The question is is there an association between anti-HLA levels and obstetrical complications
Detailed Description:
Chronic histiocytic intervillositis CHI is a rare condition with an incidence of around 5 in 10000 pregnancies It is defined by major infiltration of the intervillous cavity by CD68 maternal histiocytes associated with fibrin deposition on the villous surface
CHI is associated with severe obstetrical complications and a very high recurrence rate estimated at between 70 and 100 These complications include early and late miscarriage fetal death severe growth retardation in surviving fetuses and premature delivery The survival rate reported in the literature varies between 30 and 50
Anti-HLA antibodies are present in 54 of pregnant women at the end of pregnancy and their rate increases towards the end of pregnancy The presence of HLA antibodies also increases with the number of pregnancies and is found in up to 74 of cases after more than 2 deliveries
The research question concerns the existence of a statistically significant association between the presence of high levels of anti-HLA antibodies and the occurrence of one or more obstetric complications
CHI is associated with severe obstetrical complications and a very high recurrence rate estimated at between 70 and 100 These complications include early and late miscarriage fetal death severe growth retardation in surviving fetuses and premature delivery The survival rate reported in the literature varies between 30 and 50
Anti-HLA antibodies are present in 54 of pregnant women at the end of pregnancy and their rate increases towards the end of pregnancy The presence of HLA antibodies also increases with the number of pregnancies and is found in up to 74 of cases after more than 2 deliveries
The research question concerns the existence of a statistically significant association between the presence of high levels of anti-HLA antibodies and the occurrence of one or more obstetric complications
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2021-A01199-32 | REGISTRY | IDRCB | None |