- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03605511
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
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
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Lucy Neave, MBBS
- Phone Number: +44 203 447 9884
- Email: lucy.neave.17@ucl.ac.uk
Study Locations
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London, United Kingdom, NW1 2PG
- Recruiting
- University College London Hospital
-
Contact:
- Lucy Neave, MBBS
- Email: lucy.neave.17@ucl.ac.uk
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Frequency of TTP and aHUS in the cohort
Time Frame: At study completion, approximately 18 months after recruitment of first patient
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Number of new cases identified as a percentage of sample size
|
At study completion, approximately 18 months after recruitment of first patient
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Immune System Diseases
- Kidney Diseases
- Urologic Diseases
- Disease
- Hematologic Diseases
- Hemorrhage
- Anemia
- Pregnancy Complications
- Blood Coagulation Disorders
- Skin Manifestations
- Blood Platelet Disorders
- Thrombophilia
- Death
- Anemia, Hemolytic
- Hypertension, Pregnancy-Induced
- Uremia
- Fetal Death
- Syndrome
- Purpura
- Purpura, Thrombocytopenic
- Purpura, Thrombotic Thrombocytopenic
- Thrombotic Microangiopathies
- Eclampsia
- Pre-Eclampsia
- Thrombocytopenia
- HELLP Syndrome
- Stillbirth
- Hemolytic-Uremic Syndrome
- Atypical Hemolytic Uremic Syndrome
- Physiological Effects of Drugs
- Immunologic Factors
- Complement System Proteins
Other Study ID Numbers
- 18/0217
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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