TTP and aHUS in Complicated Pregnancies

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03605511
• Other study ID #: 18/0217
• Status: Recruiting
• 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
• 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
• 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

Related Conditions & MeSH terms

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

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