Study on Pravastatin for Pregnant Patients with Preeclampsia or Intrauterine Growth Restriction

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What is this study about?

This clinical trial is focused on studying two pregnancy-related conditions: preeclampsia and intrauterine growth restriction (IUGR). Preeclampsia is a condition characterized by high blood pressure during pregnancy, which can lead to serious complications for both the mother and baby. Intrauterine growth restriction refers to a condition where the baby grows slower than expected in the womb. The study will use a medication called Pravastatin, which is commonly used to lower cholesterol, to see if it can help manage these conditions during pregnancy.

The purpose of the study is to determine if taking 40 mg of Pravastatin daily can help prolong pregnancy in women diagnosed with severe early-onset preeclampsia or IUGR between 24 and 29 weeks of gestation. Participants in the study will be randomly assigned to receive either Pravastatin or a placebo, which looks like the medication but does not contain the active ingredient. The study will monitor the duration of pregnancy from the time of inclusion until delivery.

Participants will take the medication orally in the form of a tablet. The study aims to provide insights into whether Pravastatin can be an effective treatment strategy for managing these conditions and potentially improving outcomes for both mothers and their babies. The trial is expected to continue until the end of 2027, with recruitment starting in 2025.

1 joining the trial

Upon joining the trial, you will be informed about the study’s purpose and procedures. You will be asked to provide informed consent, confirming your understanding and willingness to participate.

2 initial assessment

An initial assessment will be conducted to confirm eligibility. This includes verifying that you are between 24+0 to 29+6 weeks of pregnancy and have a diagnosis of severe early-onset preeclampsia or intrauterine growth restriction.

3 medication administration

If eligible, you will be randomly assigned to receive either a 40 mg pravastatin tablet or a placebo. The tablet is to be taken orally once daily.

The purpose of the medication is to assess its effect on prolonging the duration of pregnancy compared to standard management.

4 ongoing monitoring

Throughout the trial, regular monitoring will be conducted to track your health and the progress of your pregnancy. This may include physical examinations, blood tests, and ultrasound scans.

The monitoring aims to ensure your safety and gather data on the trial’s primary endpoint, which is the number of days the pregnancy is prolonged.

5 completion of the trial

The trial will conclude at the time of delivery. The primary outcome measured will be the duration of pregnancy from the time of inclusion in the study until delivery.

After the trial, you may be asked to participate in follow-up assessments to gather additional data on the outcomes of the treatment.

Who Can Join the Study?

Must be pregnant with a single baby.
Pregnancy must be between 24 weeks and 29 weeks and 6 days.
Must have early-onset severe preeclampsia (PE): This means having high blood pressure and other symptoms during pregnancy, but not needing immediate delivery according to the doctor’s assessment.
And/or must have intrauterine growth restriction (IUGR): This means the baby is smaller than expected for the number of weeks of pregnancy, with specific blood flow issues in the umbilical cord.
Must be able to give informed consent: This means understanding the study and agreeing to participate.

Who Cannot Join the Study?

Individuals who are not pregnant cannot participate.
Only females are eligible; males cannot participate.
Participants must be between 24.0 and 29.6 weeks of pregnancy.
Individuals with conditions other than intrauterine growth restriction (a condition where the baby grows slower than expected in the womb) or preeclampsia (a pregnancy complication characterized by high blood pressure) are excluded.
Participants must not belong to any vulnerable population groups that are not specified in the trial.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Universitat Autonoma De Barcelona	Bellaterra	Spain

Other Sites

Site Name	City	Country
Hospital Sant Joan De Deu Barcelona	Esplugues De Llobregat	Spain
Hospital Universitario 12 De Octubre	Madrid	Spain
Hospital Clinic De Barcelona	Barcelona	Spain
Huuxddbv Da Lg Scutw Czuc I Srhw Pgy	Barcelona	Spain
Hxroqzgr Vjzk dmrdciub	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
Spain	Recruiting	01.04.2025

Trial locations

Investigated drugs:

Pravastatin Sodium

Pravastatin is a medication that is being tested in this clinical trial. It is usually used to lower cholesterol levels in people with high cholesterol. In this study, it is being given to pregnant individuals who have a condition called placental insufficiency, which means the placenta is not working as well as it should. The goal is to see if taking pravastatin can help prolong the pregnancy, giving the baby more time to grow and develop before birth. This is important because the condition can lead to complications for both the mother and the baby if the pregnancy ends too early.

Intrauterine Growth Restriction – Intrauterine Growth Restriction (IUGR) is a condition where a fetus is smaller than expected for the number of weeks of pregnancy. It occurs when the fetus does not grow at the normal rate inside the womb. This can result from various factors, including problems with the placenta, maternal health issues, or genetic conditions. As the pregnancy progresses, the fetus may continue to grow at a slower rate than normal. IUGR can lead to a baby being born with a low birth weight. The condition requires careful monitoring to ensure the health and well-being of both the mother and the fetus.

Preeclampsia – Preeclampsia is a pregnancy-related condition characterized by high blood pressure and often protein in the urine. It typically occurs after the 20th week of pregnancy. The condition can lead to complications for both the mother and the baby if not managed properly. As preeclampsia progresses, it may cause swelling, sudden weight gain, and headaches. The exact cause of preeclampsia is not fully understood, but it involves abnormal development of blood vessels in the placenta. Monitoring and management are crucial to prevent further complications.

Trial ID:

2024-519853-12-00

Protocol code:

IIBSP-PRE-2024-198

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Pravastatin for Pregnant Patients with Preeclampsia or Intrauterine Growth Restriction

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