Pro-omega-3, Reduction of Inflammation and Modulation of Prematurity
试验速览
- 阶段
- 不适用
- 入组人数
- 70
- 主要终点
- Duration latency period
研究概览
简要总结
The aim of the project is to decrease the inflammatory status of pregnant women with preterm premature rupture of membranes to delay the initiation of labour that would inevitably lead to premature delivery. The main objective is to measure the mean duration between the initiation of the treatment and delivery in the two groups treated either with MAG-DHA or with the placebo.
详细描述
This randomized controlled trial will be conducted in two hospitals in the province of Quebec (CHUS, CHUQ- Site mère-enfant Soleil).
Patients between 24 and 33 weeks of gestation with a diagnosis of preterm premature rupture of membranes (PPROM) who meet all inclusion and none of the exclusion criteria will be approached to participate. Once they have signed the IFC, participants will be randomized and begin a supplementation with either MAG-DHA or the placebo until delivery or for up to 2 weeks (14 days). A total of 70 patients will be recruited.
Principal outcome: To compare the difference in duration between the start of treatment and delivery between the group receiving MAG-DHA and the group receiving placebo.
Secondary outcomes: 1) Evaluate the difference in neonatal outcome between children in the MAG-DHA group and those in the placebo group. 2) Determine the inflammatory status of the patients associated with the exposure to either MAG-DHA or the placebo.
This regimen could potentially represent an innovative approach in the management of women with a diagnosis of PPROM.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 42 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •PPROM diagnosis, gestational age between 24 and 33 weeks of gestation.
排除标准
- •multiple pregnancy, placenta previa, preeclampsia, retroplacental hematoma, chorioamnionitis, intrauterine growth retardation, severe fetal malformations
研究组 & 干预措施
MAG-DHA
1500 MG of MAG-DHA per day until childbirth or for up to 2 weeks
干预措施: MAG-DHA (Dietary Supplement)
Placebo
1500 MG of oleic acid per day until childbirth or for up to 2 weeks
干预措施: Oleic acid (Dietary Supplement)
结局指标
主要结局
Duration latency period
时间窗: From PPROM through delivery
次要结局
- Composite neonatal score(From birth through the first 28 days of life)
- Inflammatory status(Every 2-3 days from PPROM until delivery or a maximum of 14 days, whichever happens first)