CompletedPhase IVInterventional

Statins to Ameliorate early onset Pre-eclampsia

Pre-eclampsia causes dangerous high blood pressure and protein in the urine during pregnancy. When it happens early, doctors often have to deliver the baby weeks before their due date, which can mean a long stay in a specialist neonatal baby unit. At present, there is no medicine to reverse pre-eclampsia. This clinical study explores whether a medicine called pravastatin can help. Statins are widely used by millions of adults to manage cholesterol, but laboratory tests suggest they may also calm down the blood vessel problems seen in pre-eclampsia. Pregnant women between 24 and 31 weeks of pregnancy take either a daily pravastatin capsule or a dummy pill (placebo) alongside their normal hospital care until delivery. Researchers want to see if this treatment can safely improve maternal health and help pregnancies safely last longer.

At a glance

Status

Completed

Phase

Phase IV

Sponsor

University College London Hospitals NHS Foundation Trust (UK)

Enrolment target

Start

01 Jun 2011

Estimated completion

31 Jul 2014

Pre-eclampsia

What is this study about?

Pre-eclampsia is a condition that affects some pregnant women, usually in the second half of pregnancy. It causes raised blood pressure and protein to leak into the urine. For many women, it remains mild, but it can quickly become severe. Right now, there are medications to help keep blood pressure under control, but there is no cure other than delivering the baby. When pre-eclampsia develops early, between 24 and 32 weeks, early delivery is often the only safe option, meaning the newborn will usually need urgent intensive care in a special baby unit.

Scientists have recently discovered that pre-eclampsia involves certain chemical imbalances in the mother's blood vessels and the placenta. Early laboratory studies have suggested that statins—well-known medicines commonly used to lower cholesterol—might help reduce these harmful chemicals. Researchers hope that statins could soothe inflamed blood vessels and slow down pre-eclampsia, buying vital extra days or weeks for the baby to grow safely inside the womb.

The StAmP trial is designed to see whether these promising laboratory results hold true in real life. By carefully testing pravastatin against a dummy pill in pregnant women who have early pre-eclampsia, researchers aim to discover if statins can offer a safe, new way to protect both mother and child from the risks of early birth.

Key takeaways

The study tests whether a daily pravastatin pill can help treat early pre-eclampsia.
It is aimed at women between 24 and 31 weeks of pregnancy who are carrying a single baby.
Participants take one capsule daily—either pravastatin or a harmless placebo—until delivery.
Your routine NHS maternity care and blood pressure treatments will carry on as normal.
Follow-up appointments and simple checks continue until your baby is six weeks old.

Who may be eligible?

This study is open to pregnant women who have been diagnosed with early onset pre-eclampsia between 24 and nearly 32 weeks of pregnancy. To take part, you must be expecting one baby (a singleton pregnancy), and your maternity team must feel it is medically safe for your pregnancy to continue for at least another 48 hours. The doctors must also be confident that your baby is developing well without major structural problems.

You cannot join the trial if you have developed eclampsia (seizures related to blood pressure) or are already taking a statin. It is also not suitable for women with pre-existing kidney disease before pregnancy, active liver conditions unrelated to pre-eclampsia, or severe allergies to pravastatin. Women taking certain other medications that strongly interact with statins will also be excluded.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

I am currently between 24 weeks and 31 weeks plus 6 days pregnant.
I am pregnant with one baby (not twins or triplets).
I have been diagnosed with early onset pre-eclampsia.
My doctors feel it is safe for my pregnancy to continue for at least 48 hours.
I do not have long-term liver or kidney disease from before my pregnancy.
I am not already taking statin medication.

Answer every question to see your result.

What does participation involve?

If you decide to take part, your medical team will continue caring for you as normal. On top of your standard blood pressure medicines, you will take one capsule each day until your baby is born. A computer randomly chooses whether you receive pravastatin or a dummy pill (placebo). Neither you nor your doctor will know which one you are taking, ensuring the study remains completely fair.

Your care team will check your blood pressure and test your urine daily while you are in hospital. Routine blood samples will also measure the chemicals linked to pre-eclampsia. When your baby arrives, the team will ask for permission to take a small sample of blood from the umbilical cord and keep a small piece of the placenta that would normally be thrown away. After you leave the hospital, you will have one or two follow-up visits with check-ups and simple blood tests until your baby is six weeks old.

Potential risks and benefits

Taking part may not directly benefit you, as half of the women receive a dummy pill, but pravastatin might help control pre-eclampsia symptoms and reduce the need for an early birth. Statins are widely used worldwide, and serious side effects are rare, especially over short periods. However, all medicines carry some risk of mild side effects, which your medical team will monitor closely. Taking part is completely voluntary. You can choose to withdraw at any time, and doing so will never affect the quality of NHS care you and your baby receive.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Aston University
Unverified
Birmingham, England

Common questions

What is a placebo?

A placebo is an inactive dummy pill that looks and tastes exactly like the real medicine. It is used so researchers can clearly see if the real drug works better than no extra treatment.

Will taking part change my normal pregnancy care?

No. You will still receive all of your regular blood pressure medications, scans, and midwife checks. The study capsule is simply added to your daily routine.

Can I choose to receive pravastatin instead of the placebo?

No. A computer assigns the treatment by chance. This random process is the gold standard in research because it prevents bias and ensures the results are accurate.

Will the study harm my unborn baby?

Statins are widely used in adults, and laboratory tests indicate pravastatin is safe to test in pregnancy. Doctors will watch you and your baby very closely at all times.

What happens to the placenta after birth?

With your consent, doctors collect tiny pieces of the placenta and cord blood that would normally be discarded to measure drug levels and blood vessel chemicals.

How to find out more

Asif Ahmed

asif.ahmed@aston.ac.uk - Official trial record

Always speak to your GP or specialist before deciding to take part in a study.