TTP and aHUS in Complicated Pregnancies
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
1 other identifier
observational
150
1 country
1
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Sep 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 2, 2018
CompletedFirst Posted
Study publicly available on registry
July 30, 2018
CompletedStudy Start
First participant enrolled
September 21, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 14, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
March 14, 2020
CompletedSeptember 25, 2018
July 1, 2018
1.5 years
July 2, 2018
September 21, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
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
Interventions
ADAMTS 13, complement and angiogenic biomarkers
Eligibility Criteria
All women receiving obstetric care at University College Hospitals London NHS Trust over the study period
You may qualify if:
- \- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University College London Hospital
London, NW1 2PG, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 2, 2018
First Posted
July 30, 2018
Study Start
September 21, 2018
Primary Completion
March 14, 2020
Study Completion
March 14, 2020
Last Updated
September 25, 2018
Record last verified: 2018-07