TTP and aHUS in complicated pregnancies
Research type
Research Study
Full title
An observational study to determine the prevalence of pregnancy-related thrombotic thrombocytopenic purpura and atypical haemolytic uraemic syndrome in women affected by specific obstetric complications
IRAS ID
248966
Contact name
Marie Scully
Contact email
Sponsor organisation
Joint Research Office, UCL
Clinicaltrials.gov Identifier
Z6364106/2018/06/142, UCL Data Protection Registration; Pending (entry awaiting PRS review), Clinicaltrials.gov ID
Duration of Study in the UK
1 years, 6 months, 1 days
Research summary
Thrombotic thrombocytopenia purpura (TTP) and atypical haemolytic syndrome (aHUS) are both rare diseases. They share common features of widespread clumping of platelets (a type of blood cell) in small blood vessels leading to (i) low platelet levels ('thrombocytopenia')(ii) damage to organs supplied by the blood vessels due to lack of blood/oxygen and (iii) anaemia due to red cell damage and destruction as they flow past the platelet clumps ('microangiopathic haemolytic anaemia').
If untreated, TTP commonly leads to damage of the heart, brain and kidneys, whilst aHUS commonly damages the kidneys, and both conditions can be lethal. Effective treatments exist however. If these are started in a timely fashion, most patients make a full recovery. It is therefore vital that the correct diagnosis is made early, which is not always easy as they are so rare.
Pregnancy is a well recognised trigger for both diseases, and there can be serious consequences for the baby, including impaired growth and even stillbirth. Current estimates suggest that around 1 in 25000 pregnancies are affected. However, we wonder whether some cases in pregnancy are being missed, or misdiagnosed as more common conditions such as pre eclampsia, which can cause similar symptoms.
Over 18 months at UCLH we hope to recruit 100 women, who are pregnant or recently gave birth, and whose pregnancy was affected by 1+ of six different pregnancy complications. These include (i) severe preeclampsia (ii) HELLP syndrome (a very severe form of preeclampsia) (iii) stillbirth (iv) reduced growth of the baby (v) unexplained kidney damage or (vi) unexplained low platelet levels.
We will obtain clinical data from their medical records in addition to 1-2 blood samples, to determine whether they in fact have TTP or aHUS. Identifying cases will allow us to refine estimates of frequency and criteria for considering the diagnosis.
REC name
North West - Greater Manchester West Research Ethics Committee
REC reference
18/NW/0552
Date of REC Opinion
13 Aug 2018
REC opinion
Favourable Opinion