Clinical Trial: PPROM Registry (Preterm Premature Rupture of Membranes)

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational [Patient Registry]

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

Brief Summary: 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.

Detailed Summary:

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.

Sponsor: American Alliance for pProm Support

Current Primary Outcome: Early Neonatal Mortality Rate [ Time Frame: 28 days post delivery ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Stillbirth / Perinatal Mortality Rate [ Time Frame: Upon delivery ]

Original Secondary Outcome: Same as current

Information By: American Alliance for pProm Support

Dates:
Date Received: October 18, 2016
Date Started: July 2013
Date Completion: December 2025
Last Updated: December 15, 2016
Last Verified: December 2016