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TTP and aHUS in Complicated Pregnancies

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ClinicalTrials.gov Identifier: NCT03605511
Recruitment Status : Recruiting
First Posted : July 30, 2018
Last Update Posted : September 25, 2018
Sponsor:
Information provided by (Responsible Party):
University College, London

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
Thrombotic Thrombocytopenic Purpura Atypical Hemolytic Uremic Syndrome Pre-Eclampsia HELLP Syndrome Thrombocytopenia IUGR Stillbirth Thrombotic Microangiopathies Diagnostic Test: ADAMTS 13, complement and angiogenic biomarkers

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Study Type : Observational
Estimated 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 : September 21, 2018
Estimated Primary Completion Date : March 14, 2020
Estimated Study Completion Date : March 14, 2020



Intervention Details:
  • Diagnostic Test: ADAMTS 13, complement and angiogenic biomarkers
    ADAMTS 13, complement and angiogenic biomarkers


Primary Outcome Measures :
  1. Frequency of TTP and aHUS in the cohort [ Time Frame: At study completion, approximately 18 months after recruitment of first patient ]
    Number of new cases identified as a percentage of sample size



Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   Female
Sampling Method:   Non-Probability Sample
Study Population
All women receiving obstetric care at University College Hospitals London NHS Trust over the study period
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03605511


Contacts
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Contact: Lucy Neave, MBBS +44 203 447 9884 lucy.neave.17@ucl.ac.uk

Locations
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United Kingdom
University College London Hospital Recruiting
London, United Kingdom, NW1 2PG
Contact: Lucy Neave, MBBS       lucy.neave.17@ucl.ac.uk   
Sponsors and Collaborators
University College, London

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Responsible Party: University College, London
ClinicalTrials.gov Identifier: NCT03605511     History of Changes
Other Study ID Numbers: 18/0217
First Posted: July 30, 2018    Key Record Dates
Last Update Posted: September 25, 2018
Last Verified: July 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Eclampsia
Pre-Eclampsia
Stillbirth
Hemolytic-Uremic Syndrome
Atypical Hemolytic Uremic Syndrome
HELLP Syndrome
Thrombocytopenia
Purpura
Purpura, Thrombocytopenic
Purpura, Thrombotic Thrombocytopenic
Thrombotic Microangiopathies
Syndrome
Disease
Pathologic Processes
Blood Platelet Disorders
Hematologic Diseases
Blood Coagulation Disorders
Hemorrhage
Skin Manifestations
Signs and Symptoms
Immune System Diseases
Hypertension, Pregnancy-Induced
Pregnancy Complications
Uremia
Kidney Diseases
Urologic Diseases
Fetal Death
Death
Anemia, Hemolytic
Anemia