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临床试验/NCT02997345
NCT02997345招募中不适用

Patient Registry for Women Diagnosed With Preterm Premature Rupture of Membranes or PPROM During Pregnancy

American Alliance for pProm Support1 个研究点 分布在 1 个国家目标入组 3,000 人开始时间: 2013年7月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
3,000
试验地点
1
主要终点
Early Neonatal Mortality Rate

研究概览

简要总结

Preterm Premature Rupture of Membranes (PPROM) before 37 weeks of pregnancy is responsible for 40% of preterm births in the United States. The PPROM Registry aims to identify possible causes of PPROM, evaluate trends in expectant management, measure maternal and fetal care, and to review short term and long term outcomes of affected pregnancies and births.

详细描述

Detailed Description

Preterm Premature Rupture of Membranes (pProm) is a factor in 40% of preterm births. The earlier in pregnancy pProm occurs, the greater the potential latency period. Threats to the pregnancy include placental abruption, umbilical cord prolapse, infection, and insufficient pulmonary development, and preterm delivery. Management of pProm may include immediate delivery, induction, or expectant management.

It is still unclear what is considered best practice for the course of treatment in pProm pregnancies and post- delivery care of pProm babies in Neonatal Intensive Care Units (NICU), as well as the long term outcomes of pProm survivors. Unfortunately, there are few recent studies available for review and those that exist often do not reflect the current treatments or innovations that have taken place, especially in neonatal care. Many of the studies available focusing on pProm have very small sample sizes, as well as very short follow-up post-delivery, resulting in a wide range of reported outcomes, especially regarding the morbidity and mortality associated with pProm.

The pProm registry is the first of its kind and will provide a large cohort of data for study. The purpose of this registry is to better understand pregnancies and births impacted by pProm. This includes how pProm is managed in pregnancy and in how pProm neonates are cared for in the NICU; identifying trends in expectant management, and to detect short term and long term outcomes of those affected.

研究设计

研究类型
Observational
观察模型
Ecologic Or Community
时间视角
Other

入排标准

年龄范围
14 Years 至 55 Years(Child, Adult)
性别
Female
接受健康志愿者

入选标准

  • Women diagnosed with Preterm Premature Rupture of Membranes (PPROM) prior to 37 weeks of pregnancy

排除标准

  • Those without a clinical diagnosis or confirmation of PPROM in pregnancy
  • Diagnosis of PROM beyond 37 weeks of pregnancy

研究组 & 干预措施

PPROM (Preterm Premature Rupture of Membranes)

PPROM / Preterm Premature Rupture of Membranes <37 weeks

干预措施: There is no intervention associated with this study. (Other)

结局指标

主要结局

Early Neonatal Mortality Rate

时间窗: 28 days post delivery

次要结局

  • Stillbirth / Perinatal Mortality Rate(Upon delivery)

研究者

发起方
American Alliance for pProm Support
申办方类型
Other
责任方
Principal Investigator
主要研究者

Erin Thatcher

Director

American Alliance for pProm Support

研究点 (1)

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