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Statins to Ameliorate early onset Pre-eclampsia
ISRCTN ISRCTN23410175
DOI 10.1186/ISRCTN23410175
ClinicalTrials.gov identifier
EudraCT number 2009-012968-13
Public title Statins to Ameliorate early onset Pre-eclampsia
Scientific title A proof of principle, double-blind, randomised placebo-controlled, multicentre trial of pravastatin to ameliorate early onset pre-eclampsia
Acronym StAmP
Serial number at source MRC ref: G0701824, MRCIES10215; Sponsor ref: UCLH08/0350
Study hypothesis The aim of the trial is to establish whether a significant reduction of angiogenic markers by statins will alleviate the severity of early-onset pre-eclampsia (PE) in women. To test this hypothesis, we will ask the following questions:
1. Do statins, compared to placebo, inhibit anti-angiogenic factors in women with early-onset PE?
2. If this principle is established, how best can a substantive trial/health technology assessment be undertaken to develop guidance for routine use of statins in PE?
3. Are there any adverse effects to the mother or the baby?

As of 27/09/2010 this record was extensively updated to include changes to the protocol. At this time, the scientific title of this trial was amended from ‘A proof of principle randomized controlled trial for use of statins to ameliorate early severe pre-eclampsia’ to the above scientific title. All other changes can be found in the relevant field with the above update date. At this time, the anticipated start and end dates of this trial were also amended; the initial trial dates at the time of registration were as follows:
Initial anticipated start date: 01/04/2009
Initial anticipated end date: 31/03/2011

Please note that as of 14/01/2013, the following changes were made to this record:
1. The anticipated start date for this trial was updated from 01/12/2010 to 01/06/2011
2. The anticipated end date for this trial was updated from 01/06/2012 to 30/09/2013
Lay summary Not provided at time of registration
Ethics approval Added 27/09/2010:
Wales Research Ethics Committee approved on the 3rd September 2010 (ref: 10/MRE09/10)
Study design Double-blind randomised placebo-controlled trial
Countries of recruitment United Kingdom
Disease/condition/study domain Pre-eclampsia
Participants - inclusion criteria Amended as of 27/09/2010:
To be eligible for the StAmP Trial, the women must:
1. Be between 24+0 weeks' and 31+6 weeks' gestation
2. Have a singleton pregnancy
3. Have a diagnosis of early onset Pre-eclampsia
4. Be considered capable of safely continuing the pregnancy for 48 hours or more, as determined by the attending clinician
5. Obstetrician and neonatologist believe the fetus is likely to be viable
6. No major anomalies evident on the 20-week anomaly scan. Any anomaly should be assessed by the Principal Investigator and discussed with the Chief Clinical Investigator, following classification of the anomaly according to the ICD-10 codes. All major anomalies will be excluded, but minor anomalies, subject to agreement between the PI and CI will be included
7. Be capable of understanding the information provided, with use of an interpreter if required
8. Give written informed consent

Initial information at time of registration:
To be eligible for the StAmP Trial, the women must:
1. Be at least 24 weeks and less than 33 weeks' gestation (no age limits on participant)
2. Have a diagnosis of pre-eclampsia
3. Have a normal cardiotocograph
4. Be considered capable of safely continuing the pregnancy for 12 hours or more
5. Be capable of understanding the information provided, with use of interpreter if required
6. Give written informed consent
Participants - exclusion criteria Amended as of 27/09/2010:
Any women, who at the point of randomisation, exhibit any of the following are not eligible for the trial:
1. Eclampsia
2. Current use of statins
3. Contraindications to statin use (other than pregnancy) including:
3.1. Hypersensitivity to pravastatin or any of its excipients
3.2. Active liver disease or elevation of serum transaminases not thought to be related to pre-eclampsia
3.3. Pre-pregnant renal insufficiency (creatine clearance less than 30 ml/min)
3.4. Concomitant administration of potent CYP3A4 inhibitors
4. Imminent transfer to a non-trial centre due to unavailability of neonatal cots.
5. Participation in any other blinded, placebo-controlled trials of investigational medicinal products in pregnancy.
6. Significant uncertainty regarding gestational age. Under 24 weeks' gestation, pregnancies are often not considered viable and therefore women with pre-eclampsia less than 24 weeks gestation will be excluded. Women with pre-eclampsia around 32 weeks' gestation are often delivered when the mother is stable and therefore we will exclude women who develop pre-eclampsia over 32 weeks' gestation. For this reason, if there is any uncertainty about the gestational age, the mother should not be approached for randomisation.

Initial information at time of registration:
Any women, who at the point of randomisation, exhibits any of the following symptoms or contraindications, are not eligible for the trial:
1. Eclampsia
2. Absent or reversed end-diastolic flow
3. Pre-pregnant or continuing use of statins
4. Contraindications to statin use (other than pregnancy)
Anticipated start date 01/06/2011
Anticipated end date 30/09/2013
Status of trial Completed
Patient information material Not available in web format, please use the contact details below to request a patient information sheet
Target number of participants 128
Interventions As of 27/09/2010 the drug of treatment has been changed to pravastatin; this was previously simvastatin.

Oral pravastatin, 40 mg, or placebo, once daily until delivery of the baby.
Primary outcome measure(s) Effect of statins on soluble fms-like tyrosine kinase 1 (sFlt-1) at 48 hours post-randomisation.
Secondary outcome measure(s) Maternal:
1. Blood pressure and proteinuria at delivery
2. Use of ani-thypertensives during pregnancy and until 1 month post delivery
3. Severe morbidity (Haemolysis, Elevated Liver enzyme levels and a Low Platelet count [HELLP], cerebrovascular accident [CVA]). Duration of follow-up: until 1 month post-delivery.
4. Days in high dependency unit
5. Total hospital stay
6. Mortality (up to 42 days post delivery)
7. Drug adverse effects during pregnancy

Neonatal outcomes:
1. Apgar at 5 min
2. Birth weight
3. Complications of prematurity (retinopathy, necrotizing enterocolitis [NEC], intraventricular haemorrhage [IVH])
4. Days in special care dependency unit
5. Mortality up to 28 days old
6. Drug adverse effects apparent at delivery
7. Congenital anomalies
Sources of funding Medical Research Council (UK) (ref: G0701824, MRCIES10215)
Trial website http://www.birmingham.ac.uk/stamp
Publications
Contact name Prof  Asif  Ahmed
  Address Aston University
Life & Health Sciences
Aston Triangle
  City/town Birmingham
  Zip/Postcode B4 7ET
  Country United Kingdom
  Email asif.ahmed@aston.ac.uk
Sponsor University College London Hospitals NHS Foundation Trust (UK)
  Address (Chief Investigator: Dr David Williams)
c/o Ms Salwa Beydoun
Joint UCLH/UCL Biomedical Research and Development (R&D) Unit
(1st Floor, Maple House)
Ground Floor, Rosenheim Wing
25 Grafton Way
  City/town London
  Zip/Postcode WC1E 6DB
  Country United Kingdom
  Email s.beydoun@ucl.ac.uk
  Sponsor website: http://www.uclh.nhs.uk
Date applied 17/11/2008
Last edited 17/01/2013
Date ISRCTN assigned 08/05/2009
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