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Clinical Trial Details — Status: Recruiting

Administrative data

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

Study information

Verified date July 2018
Source University College, London
Contact Lucy Neave, MBBS
Phone +44 203 447 9884
Email lucy.neave.17@ucl.ac.uk
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
ADAMTS 13, complement and angiogenic biomarkers
ADAMTS 13, complement and angiogenic biomarkers

Locations

Country Name City State
United Kingdom University College London Hospital London

Sponsors (1)

Lead Sponsor Collaborator
University College, London

Country where clinical trial is conducted

United Kingdom, 

Outcome

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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