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临床试验/NCT00457886
NCT00457886已完成不适用

Serum Levels of Hormones Known to Affect Parturition in Patients Receiving 17 Alpha-Hydroxyprogesterone Caproate (17-P) for the Prevention of Preterm Delivery

Georgetown University1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2005年7月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
20
试验地点
1

研究概览

简要总结

The purpose of this study is to measure hormones in the blood known to affect the timing of delivery after a single injection of 17-P in order to help understand its mechanism of action in preventing preterm delivery.

详细描述

A recent study by Meis and colleagues published in the New England Journal of Medicine in June 2003 demonstrated a 33% reduction in the rate of preterm delivery in patients with a previous history of preterm delivery who then used weekly 17-P injections in the subsequent pregnancy.

This is a milestone in the prevention of preterm delivery and is the reason you have chosen to receive treatment with 17-P.

However, how 17-P works to prevent preterm delivery is unclear. Knowledge of the mechanism of action of 17-P would help in selecting patients for treatment and may be useful in monitoring the efficacy of therapy.

Studies have suggested that the timing of delivery depends on a type of placental clock, affected by levels of corticotropin-releasing hormone (CRH) and progesterone (P).

CRH can be thought to act as an accelerator, and P as a brake. Serial injections of 17-P beginning in the second trimester of pregnancy may prevent preterm delivery by maintaining progesterone dominance, and be reflected in increased levels of progesterone and/or 17-P, or decreased levels of cortisol and/or CRH. These are the hormones that will be measured in this study.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

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

  • Spontaneous preterm delivery in a previous pregnancy, are between 15-20 weeks gestation during the current pregnancy, and have already decided whether or not to receive 17-alphahydroxyprogesterone caproate (17-P) for the prevention of preterm delivery.

排除标准

  • Multiple gestation
  • Known fetal anomaly
  • Progesterone or heparin treatment during the current pregnancy
  • Seizure disorder
  • Pre-existing or gestational diabetes
  • Hypertension requiring medication
  • Thyroid or adrenal gland disorder

研究者

申办方类型
Other

研究点 (1)

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