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临床试验/NCT00719537
NCT00719537终止不适用

Oral Progesterone and Low Dose Aspirin in the Prevention of Preeclampsia in Patients With a Prior History of Preeclampsia: A Prospective, Randomized Clinical Trial

John Uckele1 个研究点 分布在 1 个国家目标入组 3 人开始时间: 2008年7月最近更新:
适应症
干预措施
相关药物

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

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

Placebo Comparator

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

Placebo Comparator

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

Active Comparator

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

Active Comparator

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

发起方
John Uckele
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

John Uckele

Medical Doctor

William Beaumont Hospitals

研究点 (1)

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