Statins to Ameliorate early onset Pre-eclampsia

• Register: ISRCTN
• Last refreshed on: 17 June 2019
• Main ID: ISRCTN23410175
• Date of registration: 08/05/2009
• Prospective Registration: Yes
• Primary sponsor: University College London Hospitals NHS Foundation Trust (UK)
• 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
• Date of first enrolment: 01/06/2011
• Target sample size: 64
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN23410175
• Study type: Interventional
• Study design: Double-blind randomised placebo-controlled trial (Treatment)
• Phase: Phase IV

Countries of recruitment

United Kingdom

Contacts

• Name: Asif Ahmed

Key inclusion & exclusion criteria

Inclusion criteria:
Current inclusion criteria 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

Previous inclusion criteria:
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

Exclusion criteria:
Current exclusion criteria 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.

Previous exclusion criteria:
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)


Age minimum:
Age maximum:
Gender: Female

Health Condition(s) or Problem(s) studied

Pre-eclampsia
Pregnancy and Childbirth
Gestational [pregnancy-induced] hypertension with significant proteinuria

Intervention(s)

On 27/09/2010 the drug of treatment was changed to pravastatin; this was previously simvastatin.

Oral pravastatin, 40 mg, or placebo, once daily until delivery of the baby.

Primary Outcome(s)

Effect of statins on soluble fms-like tyrosine kinase 1 (sFlt-1) at 48 hours post-randomisation

Secondary Outcome(s)

Maternal:
1. Blood pressure and proteinuria at delivery
2. Use of anti-hypertensives 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

Secondary ID(s)

2009-012968-13

MRC ref: G0701824, MRCIES10215; Sponsor ref: UCLH08/0350

Source(s) of Monetary Support

Medical Research Council (UK) (ref: G0701824, MRCIES10215)

Ethics review

Status:
Approval date:
Contact:

Wales Research Ethics Committee, 03/09/2010, ref: 10/MRE09/10

Results

• Results available: Yes
• Date Completed: 31/07/2014