Preeclampsia Intervention 4 – A double blind phase III randomised controlled trial assessing metformin to prolong gestation in preterm preeclampsia
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 294
- 试验地点
- 7
- 主要终点
- The primary endpoint is prolongation of gestation, defined as days and hours from randomisation to delivery. Prolongation of gestation in pregnancies with intrauterine fetal demise will be considered as interval censored between time from randomisation to last visit preceding delivery (where the baby was known to be alive) and time from randomisation to delivery.
研究概览
简要总结
To examine whether 3 grams of metformin ER daily can prolong gestation in pregnancies complicated by preterm preeclampsia diagnosed 22+0–33+6 weeks in women undergoing expectant management, compared to placebo.
入排标准
- 年龄范围
- 0 years 至 64 years（0-17 Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •A diagnosis of preeclampsia has been made by the attending clinician
- •The managing clinicians have made the assessment to proceed with expectant management and that delivery is not expected within 48 hours
- •The subject has given written consent to participate in the study.
- •The woman must be 18 years of age or older
- •The gestational age is between 22+0 weeks to 33+6 weeks with a viable fetus
- •The woman carries a singleton pregnancy
排除标准
- •There are contraindications to treatment with metformin as outlined in SmPC (Attachment E)
- •Not suitable for inclusion by the opinion of the investigator
- •Contraindications for expectant management of preeclampsia such as an immediate indication for delivery according to Swedish guidelines.
- •Current use of metformin
- •Known or suspected allergies against metformin
- •Reluctance or language difficulties that result in difficulty understanding the meaning of study participation
- •Unable to understand the informed consent process
- •Previous participation in the study
- •Established fetal compromise that necessitates imminent delivery (including planned delivery after 48 hours of corticosteroid treatment). This will be decided by the clinical team before expectant management is offered to the patient.
- •Diabetes type 1
- •Suspicion of a major known fetal anomaly or malformation.
- •Renal disease or dysfunction, suggested by a creatinine level greater than or equal to 125 µmol/L or rapidly declining renal function
- •Known acute or chronic metabolic acidosis, including diabetic ketoacidosis
结局指标
主要结局
The primary endpoint is prolongation of gestation, defined as days and hours from randomisation to delivery. Prolongation of gestation in pregnancies with intrauterine fetal demise will be considered as interval censored between time from randomisation to last visit preceding delivery (where the baby was known to be alive) and time from randomisation to delivery.
The primary endpoint is prolongation of gestation, defined as days and hours from randomisation to delivery. Prolongation of gestation in pregnancies with intrauterine fetal demise will be considered as interval censored between time from randomisation to last visit preceding delivery (where the baby was known to be alive) and time from randomisation to delivery.
次要结局
- Length of neonatal stay, defined as days and hours from birth to discharge from neonatal care, including both hospital and home-based care. Length of neonatal stay will be as zero if the infant was not admitted to neonatal care.
- Neonatal birthweight, in grams.
研究者
Lina Bergman
Scientific
Vastra Gotalandsregionen