Patient Registry for Women Diagnosed With Preterm Premature Rupture of Membranes or PPROM During Pregnancy
概览
- 阶段
- 不适用
- 干预措施
- There is no intervention associated with this study.
- 疾病 / 适应症
- Fetal Membranes, Premature Rupture
- 发起方
- American Alliance for pProm Support
- 入组人数
- 3000
- 试验地点
- 1
- 主要终点
- Early Neonatal Mortality Rate
- 状态
- 招募中
- 最后更新
- 上个月
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.
研究者
Erin Thatcher
Director
American Alliance for pProm Support
入排标准
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.
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)