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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03605511

Enrollment

150

Registered

2018-07-30

Start date

2018-09-21

Completion date

2020-03-14

Last updated

2018-09-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atypical Hemolytic Uremic Syndrome, HELLP Syndrome, IUGR, Pre-Eclampsia, Stillbirth, Thrombocytopenia, Thrombotic Microangiopathies, Thrombotic Thrombocytopenic Purpura

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

Interventions

DIAGNOSTIC_TESTADAMTS 13, complement and angiogenic biomarkers

ADAMTS 13, complement and angiogenic biomarkers

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

16 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
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

Countries

United Kingdom

Contacts

Primary ContactLucy Neave, MBBS

lucy.neave.17@ucl.ac.uk+44 203 447 9884

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026