The PIONEER Study - A study to investigate whether taking the medication Pravastatin reduces the number of babies born too early (preterm, i.e., before 37 weeks of pregnancy) and, if so, how it works in the body to do this.
- Conditions
- Intermediate or high risk for preterm birthPregnancy and Childbirth
- Registration Number
- ISRCTN93398587
- Lead Sponsor
- niversity Hospitals Bristol and Weston NHS Foundation Trust
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing
- Sex
- Female
- Target Recruitment
- 750
1. Pregnant people with a singleton pregnancy identified as being at high or intermediate risk for PTB according to criteria detailed in the Saving Babies’ Lives Care Bundle (V3), where:
1.1. High risk - at least one of the following:
1.1.1. Previous mid-trimester loss >16 weeks' gestation;
1.1.2. Previous PTB <34 week's gestation;
1.1.3. Previous Preterm Premature Rupture of Membranes (PPROM) <34 weeks’ gestation;
1.1.4. Previous use of cervical cerclage;
1.1.5. Known uterine structural variant;
1.1.6. Intrauterine adhesions;
1.1.7. History of trachelectomy (for cervical cancer).
OR
1.2. Intermediate risk - at least one of the following:
1.2.1. Previous birth by caesarean section at full dilatation;
1.2.2. History of significant excision of cervical cells (e.g., Large Loop Excision of Transformation Zone (LLETZ) where >15mm depth removed, or >1 LLETZ procedure carried out or cone biopsy).
2. Between 16+0- and 20+0 weeks’ gestation at randomisation.
1. Multiple pregnancy
2. <16 years of age
3. Hypersensitivity to Pravastatin (active substance or any of the excipients)
4. Personal or first-degree relative with heritable muscle disorder
5. Participating in the active phase of another CTIMP
6. Lactose intolerance
7. >14 units alcohol/week
8. Past/current liver disease
9. ALT or AST above upper limit of normal (as set by local laboratories), to be taken at the time of screening*
10. Bilirubin above upper limit of normal (as set by local laboratories), to be taken at the time of screening*
11. Creatine Kinase (CK) concentration >5 times upper limit of normal (as set by local laboratories), to be taken at the time of screening
12. Currently breastfeeding
13. Unable to provide informed consent
14. Previously participated in PIONEER
15. Currently taking medicines or groups of medicines that are contraindicated for concomitant use with pravastatin§
* It is acknowledged that the Liver Function Test may include different assessments at different sites, therefore for the purpose of the screening blood test, the term Liver Function Test” at screening should include measurement of Bilirubin and at least one of ALT or AST. If any of these are above the upper limit of the normal, the person would not be eligible for inclusion in PIONEER, and should have ongoing follow-up according to local policy.
§ Those taking macrolides should be excluded from PIONEER, however, if a limited course of macrolides are prescribed with the course due to complete prior to 20+0 weeks’ gestation, then it may be possible to recruit to PIONEER following completion of the course of antibiotics (if completion of the course of antibiotics is prior to 20+0).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Gestational age, in days, at birth, measured using patient records.
- Secondary Outcome Measures
Name Time Method