PPROM Registry (Preterm Premature Rupture of Membranes)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: There is no intervention associated with this study..
- Who it may be relevant to
- Registry conditions: Fetal Membranes, Premature Rupture, Preterm Premature Rupture of the Membranes, Oligohydramnios, Premature Birth. Basic parameters: 14 years — 55 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Patient Registry for Women Diagnosed With Preterm Premature Rupture of Membranes or PPROM During Pregnancy
Overview
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 description
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.
Interventions
- Other There is no intervention associated with this study.
There is no intervention associated with this study.
Primary outcome measures
- Early Neonatal Mortality Rate [Time frame: 28 days post delivery]
Secondary outcome measures (1)
- Stillbirth / Perinatal Mortality Rate [Time frame: Upon delivery]
Eligibility criteria
Inclusion criteria
- Women diagnosed with Preterm Premature Rupture of Membranes (PPROM) prior to 37 weeks of pregnancy
Exclusion criteria
- Those without a clinical diagnosis or confirmation of PPROM in pregnancy
- Diagnosis of PROM beyond 37 weeks of pregnancy
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Ecologic or community
Study locations
United States · 1 center
- Www.Aapprom.Org/the-Registry — Denver
Identifiers
NCT: NCT02997345 · tpr072013