Pre-Eclampsia Clinical Trial
Official title:
A Observational Study to Determine the Prevalence of Pregnancy-related Thrombotic Thrombocytopenic Purpura and Atypical Haemolytic Uraemic Syndrome in Women Affected by Specific Obstetric Complications
NCT number | NCT03605511 |
Other study ID # | 18/0217 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | September 21, 2018 |
Est. completion date | March 14, 2020 |
A single site observational study aiming to:
(i) Identify cases of previously undiagnosed thrombotic thrombocytopenic purpura (TTP) and
atypical haemolytic syndrome (aHUS) in a cohort of women with complicated pregnancies (ii)
Characterise the clinical features of these cases and (ii) Identify clinical features or
biomarkers which may help distinguish TTP/aHUS from other complications of pregnancy such as
preeclampsia
Status | Recruiting |
Enrollment | 150 |
Est. completion date | March 14, 2020 |
Est. primary completion date | March 14, 2020 |
Accepts healthy volunteers | |
Gender | Female |
Age group | 16 Years and older |
Eligibility |
Inclusion Criteria: - Women, either currently pregnant or recently postpartum, and affected by one or more of the following complications in the index pregnancy: (i) Preeclampsia with evidence of end organ damage (renal/ liver/ haematological/ neurological) or uteroplacental dysfunction (FGR/IUFD) (ii) HELLP syndrome (iii) Fetal growth restriction (FGR) (growth <10th centile) that is unexplained (ie not due to infection, fetal structural anomaly, fetal chromosomal or pre-existing maternal medical problem) (iv) Intrauterine fetal demise (IUFD) after 20 weeks' gestation that is unexplained (v) Unexplained new onset renal impairment (defined by serum creatinine >85umol/L 1st trimester, or >80umol/L 2nd trimester, or >90 umol/L 3rd trimester[32]; OR an increase in serum creatinine by (i) at least 1.5 times the baseline or (ii) of equal or greater than 26.5umol/L (as per KDIGO criteria) (vi) Unexplained new onset thrombocytopenia (platelets <75x10^9/L) Exclusion Criteria: - Previous diagnosis of TTP or aHUS - Known disorder of complement dysregulation - Patients not wishing to participate - Patients aged less than 16 - Patients lacking capacity to provide informed consent |
Country | Name | City | State |
---|---|---|---|
United Kingdom | University College London Hospital | London |
Lead Sponsor | Collaborator |
---|---|
University College, London |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Frequency of TTP and aHUS in the cohort | Number of new cases identified as a percentage of sample size | At study completion, approximately 18 months after recruitment of first patient |
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