PPROM Registry (Preterm Premature Rupture of Membranes)
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|ClinicalTrials.gov Identifier: NCT02997345|
Recruitment Status : Recruiting
First Posted : December 20, 2016
Last Update Posted : August 27, 2019
|Condition or disease||Intervention/treatment|
|Fetal Membranes, Premature Rupture Preterm Premature Rupture of the Membranes Oligohydramnios Premature Birth||Other: There is no intervention associated with this study.|
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.
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||3000 participants|
|Observational Model:||Ecologic or Community|
|Target Follow-Up Duration:||1 Year|
|Official Title:||Patient Registry for Women Diagnosed With Preterm Premature Rupture of Membranes or PPROM During Pregnancy|
|Study Start Date :||July 2013|
|Estimated Primary Completion Date :||December 2025|
|Estimated Study Completion Date :||December 2025|
PPROM (Preterm Premature Rupture of Membranes)
PPROM / Preterm Premature Rupture of Membranes <37 weeks
Other: There is no intervention associated with this study.
There is no intervention associated with this study.
- Early Neonatal Mortality Rate [ Time Frame: 28 days post delivery ]
- Stillbirth / Perinatal Mortality Rate [ Time Frame: Upon delivery ]
- Review of Socio-Economic Factors in pProm [ Time Frame: Single assessment (observational) at conclusion of pregnancy +30 days, monitored for up to 100 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02997345
|Contact: Erin Thatcher||(740) 837-7766|
|United States, Colorado|
|Denver, Colorado, United States, 80202|
|Contact: Erin 740-837-7766 email@example.com|