Clinical trial NCT02997345: PPROM Registry (Preterm Premature Rupture of Membranes)
Official title: Patient Registry for Women Diagnosed With Preterm Premature Rupture of Membranes or PPROM During Pregnancy
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Fetal Membranes, Premature Rupture
Preterm Premature Rupture of the Membranes
Oligohydramnios
Premature Birth
Keywords: PPROM
Lead sponsor: American Alliance for pProm Support
Sponsor class: OTHER
First posted: 2016-12-20
Enrollment: 3000
Sex: FEMALE
Minimum age (years): 14
Maximum age (years): 55
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women diagnosed with Preterm Premature Rupture of Membranes (PPROM) prior to 37 weeks of 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 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.

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

Primary outcomes:
measure: Early Neonatal Mortality Rate
timeFrame: 28 days post delivery
Secondary outcomes:
measure: Stillbirth / Perinatal Mortality Rate
timeFrame: Upon delivery
Other outcomes:
measure: Review of Socio-Economic Factors in pProm
timeFrame: Single assessment (observational) at conclusion of pregnancy +30 days, monitored for up to 100 months
Locations:
city: Denver
country: United States
facility: Www.Aapprom.Org/the-Registry
state: Colorado
Study officials:
References: