Oral Progesterone and Low Dose Aspirin in the Prevention of Preeclampsia in Patients With a Prior History of Preeclampsia: A Prospective, Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- Incidence of Preeclampsia
研究概览
简要总结
This study investigates whether low dose aspirin combined with progesterone will decrease the risk of preeclampsia in pregnant women with a history of preeclampsia in a previous pregnancy.
详细描述
Recent advances have shown that certain proteins may be present in a pregnant woman's blood very early in pregnancy which can predict who is at the highest risk for developing preeclampsia. These proteins can be measured and may be used to predict a woman's risk of developing preeclampsia.
Special placental cells called endovascular cytotrophoblasts are needed in the early formation of the placenta. These placental cells invade the maternal blood vessels in the formation of the maternal-placental blood interface. Human Leukocytes Antigen-G (HLA-G) is a protein produced by the placental cells and prevents these special cells from being rejected by the mother's immune system. Recent studies have indicated that the level of HLA-G is decreased in placentas from mothers with preeclampsia. Progesterone, a naturally occurring hormone produced in pregnancy, has been shown to increase the production of HLA-G in the placental cytotrophoblast cells.
In regards to the treatment of preeclampsia, studies have shown that low dose aspirin if given to mothers who have had severe early preeclampsia, lowers the risk for having preeclampsia again. This study aims to show that low dose aspirin combined with progesterone will decrease the risk of preeclampsia in pregnant women with a history of preeclampsia in a previous pregnancy. Data generated will determine levels and ratios of blood proteins that are predictive of preeclampsia at specific gestational ages.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years(Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •pregnant patients with a previous history of preeclampsia in the immediate preceding pregnancy.
- •18 to 45 years of age will be included.
排除标准
- •Patients with chronic hypertension
- •children (age < 17 years)
- •Patients that are currently taking anti-psychotics or Selective Serotonin Re-uptake Inhibitors
- •patients on medications which may be detrimental to the study interpretation will also be excluded at the principal investigator's discretion.
研究组 & 干预措施
Aspirin plus Placebo Oral Tablet
Drug: Aspirin 81 mg, given orally once per day Drug: Placebo tablet given orally, once a day
干预措施: Aspirin (Drug)
Aspirin plus Placebo Oral Tablet
Drug: Aspirin 81 mg, given orally once per day Drug: Placebo tablet given orally, once a day
干预措施: Placebo Oral Tablet (Drug)
Aspirin plus Progesterone
Drug: Aspirin 81mg, given orally once per day Drug: Progesterone 200mg given orally, once a day
干预措施: Aspirin (Drug)
Aspirin plus Progesterone
Drug: Aspirin 81mg, given orally once per day Drug: Progesterone 200mg given orally, once a day
干预措施: Progesterone (Drug)
结局指标
主要结局
Incidence of Preeclampsia
时间窗: second and third trimester of pregnancy
Number of Participants with preeclampsia in second and third trimester of pregnancy.
次要结局
未报告次要终点
研究者
John Uckele
Medical Doctor
William Beaumont Hospitals
