Benefits
There is a possibility that participants who receive Pravastatin will have a lower chance of an early birth, but we cannot be certain. This is what this study will help us to find out. You may also benefit from the increased contact that comes with being a part of a clinical study.
The information we get from this study may help us to improve the options for pregnant women who are at risk of preterm birth in the future.
Risks
Possible disadvantages of taking part in this study include:
Attending research visits at the hospital and completing the follow up activities at home will take up some of your time. The researchers involved in the study will do their best to work around you when organising visits and calls and, where possible, organise research visits to coincide with your appointments at the Preterm Birth Prevention clinic.
Taking a blood sample may cause discomfort or bruising.
Taking a vaginal swab may cause some discomfort but it should not be painful. Providing and posting a stool sample may be inconvenient. You will be provided with pre-packaged sampling kits to limit this as much as possible.
There should be little disadvantage associated with participating in the Information Study as this only involves audio-recording conversations you have with hospital staff and researchers and/or taking part in a telephone or virtual interview.
Taking part in an interview may involve discussion of sensitive issues, such as your motivations for accepting or declining study participation; however, the research team and interviewer will be fully trained and will support you during these discussions. Most people find these conversations helpful, but some can find it upsetting. If this happens, you will be able to stop the visit or interview at any time, without giving a reason. Completing the interview will also take up some of your time.
Pravastatin is a statin, and there are some potential side effects which may be experienced, which are described in the patient information sheet you will receive, and will be discussed with you. Pravastatin has been used previously in pregnancy research, and there has been no evidence of harm to babies. Of note, neither you nor your doctors will know whether you have been allocated to receive Pravastatin during the study. In the event of a medical emergency, healthcare professionals can contact an on-call pharmacist available 24 hours a day to access information about the treatment you are taking.