TTP and aHUS in Complicated Pregnancies

NCT ID: NCT03605511

Last Updated: 2018-09-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-09-21

Study Completion Date

2020-03-14

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

ADAMTS 13, complement and angiogenic biomarkers

ADAMTS 13, complement and angiogenic biomarkers

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

16 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University College, London

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University College London Hospital

London, , United Kingdom

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United Kingdom

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Lucy Neave, MBBS

Role: CONTACT

+44 203 447 9884

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Lucy Neave, MBBS

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

18/0217

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

sCD163 in HELLP Syndrome
NCT07209748 NOT_YET_RECRUITING
The Use of Eculizumab in HELLP Syndrome
NCT04103489 COMPLETED PHASE1
Platelets in Pregnancy
NCT06194643 ACTIVE_NOT_RECRUITING