Is my site mechanistic or non-mechanistic?
Click on Contact Information & Participating sites to find your site on our map of PIONEER participating sites. The information below explains the difference.
What would taking part at a mechanistic site involve?
Pravastatin, or a placebo (a tablet that looks like Pravastatin but does not contain any active ingredients), would be taken once a day starting between 16+0-20+0 weeks of pregnancy until 37+0 weeks of pregnancy, or if you give birth earlier, or if you are asked to take Erythromycin for Preterm Prelabour Rupture of Membranes (PPROM).
We will take a sample of blood from you at the start of the study to help check if you are eligible to take part. You will also have a blood test at 28 weeks to monitor your liver function. You may then be asked to stop treatment depending on the results of this test.
We will also ask you to provide additional blood samples, stool samples and vaginal swabs at three visits to understand how Pravastatin might work within your body to prevent preterm birth.
We want to know if Pravastatin has more side effects than placebo, and we will ask you to complete one short questionnaire about this.
We will also ask you to bring any medication that hasn’t been taken back to us so we can complete a tablet count to see if the treatment is being taken as expected.
Some participants may be asked to complete a questionnaire about their child’s development once their child is 2 years old.
A flow diagram showing what will happen during the study at a mechanistic site is shown below.
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Open in new tab What would taking part at a non-mechanistic site involve?
Pravastatin, or a placebo (a tablet that looks like Pravastatin but does not contain any active ingredients), would be taken once a day starting between 16+0-20+0 weeks of pregnancy until 37+0 weeks of pregnancy, or if you give birth earlier, or if you are asked to take Erythromycin for Preterm Prelabour Rupture of Membranes (PPROM).
We will take a sample of blood from you at the start of the study to help check if you are eligible to take part. You will also have a blood test at 28 weeks to monitor your liver function. You may then be asked to stop treatment depending on the results of this test.
We want to know if Pravastatin has more side effects than placebo, and we will ask you to complete one short questionnaire about this.
We will also ask you to bring any medication that hasn’t been taken back to us so we can complete a tablet count to see if the treatment is being taken as expected.
Some participants may be asked to complete a questionnaire about their child’s development once their child is 2 years old.
A flow diagram showing what will happen during the study at a non-mechanistic site is shown below.
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