TTP and aHUS in Complicated Pregnancies

Sponsor

University College, London (Other)

Overall Status

Unknown status

CT.gov ID

NCT03605511

Collaborator

(none)

150

Enrollment

Location

17.7

Anticipated Duration (Months)

8.5

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Thrombotic Thrombocytopenic Purpura Atypical Hemolytic Uremic Syndrome Pre-Eclampsia HELLP Syndrome Thrombocytopenia IUGR Stillbirth Thrombotic Microangiopathies	Diagnostic Test: ADAMTS 13, complement and angiogenic biomarkers

Study Design

Study Type:

Observational

Anticipated Enrollment :

150 participants

Observational Model:

Cohort

Time Perspective:

Prospective

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

Actual Study Start Date :

Sep 21, 2018

Anticipated Primary Completion Date :

Mar 14, 2020

Anticipated Study Completion Date :

Mar 14, 2020

Outcome Measures

Primary Outcome Measures

Frequency of TTP and aHUS in the cohort [At study completion, approximately 18 months after recruitment of first patient]
Number of new cases identified as a percentage of sample size

Eligibility Criteria

Criteria

Ages Eligible for Study:

16 Years and Older

Sexes Eligible for Study:

Female

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)