A Prospective Interventional Randomized Controlled Trial to Assess the Effect of Low Dose Acetylsalicylic Acid As a Preventive Treatment of Pre-eclampsia in Pregnant Women Who Underwent Frozen Embryo Transfer
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 276
- 试验地点
- 1
- 主要终点
- Mean number of women suffering from pre-eclampsia in the treated and not treated groups.
研究概览
简要总结
Title: A prospective multicentric interventional randomized controlled trial to assess the effect of low dose acetylsalicylic acid as a preventive treatment of pre-eclampsia in pregnant women who underwent frozen embryo transfer
详细描述
Method: Prospective, interventional, multicentric randomized controlled trial, to evaluate the utility of a preventive treatment with low dose acetylsalicylic acid from the embryo transfer and throughout pregnancy in patients who have had a frozen embryo transfer.
During the first consultation, patients will be introduced to the study. They can choose to participate or not. If they agree to participate, they will be randomized in two groups (1:1), treated or not. The randomization will be realized by the RedCap software. Patients with natural and modified natural cycle and hormone replacement treatment (HRT) cycle will be included. As soon as an evolutive intrauterine pregnancy is diagnosed, in the treated group, she will receive a daily dose of 160mg acetylsalicylic acid, until 36 weeks of amenorrhea. Patients of both groups will be followed twice a month (regular prenatal visit and phone call).
Primary goal: To assess the incidence of pre-eclamspia in women who underwent a frozen embryo transfer treated with 160mg of acetylsalicylic acid versus no treatment.
Primary endpoint: Mean number of women suffering from preeclampsia in the treated and not treated groups.
Secondary goals:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 43 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Healthy women from [18 - 43] years-old, planned for a frozen embryo transfer, with natural and modified natural or HRT cycle
- •Who have given their informed consent
- •Who have a confirmed pregnancy at week 6 of amenorrhea.
排除标准
- •Women presenting one risk factor for preeclampsia: multiple pregnancy, history of preeclampsia, BMI > 30, lupus syndrome, preexistent proteinuria, non-treated chronic high blood pressure (>140/90), antiphospholipid antibody syndrome, diabetes (fasting blood sugar >126mg/dl)
- •Contraindication to acetylsalicylic acid (at risk of active hemorrhage (like hemophilia, ...); at risk of or who have a gastro-duodenal ulcer; at risk or how have a terminal renal or hepatic in-sufficiency (only if acetylsalicylic acid is given at high dose)
- •Already treated with acetylsalicylic acid
- •Treatment with anticoagulants or non-steroid anti-inflammatory drugs
研究组 & 干预措施
Treatment by acetylsalicylic acid
干预措施: Acetylsalicylic acid (Drug)
结局指标
主要结局
Mean number of women suffering from pre-eclampsia in the treated and not treated groups.
时间窗: 4 years
次要结局
未报告次要终点
研究者
Julie Collee
Doctor, specialist in Obstetrics and Reproductive Medicine
Centre Hospitalier Régional de la Citadelle