ISRCTN93398587进行中（未招募）3 期
PravastatIn tO preveNt prEtErm biRth (PIONEER): a parallel group randomised placebo-controlled trial
niversity Hospitals Bristol and Weston NHS Foundation Trust0 个研究点目标入组 750 人开始时间: 2024年4月18日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 750
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- Female
入选标准
- •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).
- •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.
排除标准
- •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).
研究者
相似试验
招募中
不适用
Pre-frail New efforts to prevent the progression of frail by intervention of agarooligosaccharides in the elderlyfrailJPRN-UMIN000046285Matsumoo university30
已完成
不适用
PREVENT-TAKE-UP– a prevention and early detection app for integrated breast cancer, colorectal cancer, and prostate cancer screeningThe project is in the primary prevention, a study of diseases / health problems does not take place.DRKS00029631niversitätsklinikum Ulm122
招募中
3 期
Study title and acronym: INcreasing the upTakE of IPTp-SP throuGh Seasonal MalaRiA ChemoprevenTION channel delivery - INTEGRATIOMalariaPACTR202208844472053niversity of Sciences Techniques and Technologies of Bamako1,974
已完成
不适用
A good start: An early intervention to prevent the development of antisocial behavior in infantshet onderzoek richt zich niet op bepaalde aandoeningen maar meer op een verzameling van factoren die maken dat een (aanstaande) moeder verminderd in staat is om zich goed aan te passen aan het moederschap, dat kunnen problemen zijn in de psychische gezondheid, financiele situatie, huisvesting, sociale steun, levensstijl, werkloosheid, uitval in het onderwijs en dergelijke-NL-OMON43843niversiteit Leiden180
已完成
不适用
SE OF AN OPD DRUG TO PREVENT PROLONGED PREGNANCYCTRI/2014/09/005006niversity College of Medical Sciences and Guru Teg Bahadur HOSPITA130