PPROM Registry (Preterm Premature Rupture of Membranes)

Recruiting

• Conditions: Fetal Membranes, Premature Rupture; Preterm Premature Rupture of the Membranes; Premature Birth; Oligohydramnios
• Interventions: Other: There is no intervention associated with this study.

• Registration Number: NCT02997345
• Lead Sponsor: American Alliance for pProm Support

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.

Study Timeline

• Study Start: 2013-07
• Study First Submitted: 2016-10-18
• Study First Submitted QC: 2016-12-15
• Study First Posted: 2016-12-20
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-14
• Last Update Posted: 2022-03-02
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 3000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
PPROM (Preterm Premature Rupture of Membranes)	There is no intervention associated with this study.	PPROM / Preterm Premature Rupture of Membranes \<37 weeks

Primary Outcome Measures

Name	Time	Method
Early Neonatal Mortality Rate	28 days post delivery

Secondary Outcome Measures

Name	Time	Method
Stillbirth / Perinatal Mortality Rate	Upon delivery

Trial Locations

Locations (1)

Www.Aapprom.Org/the-Registry; 🇺🇸 Denver, Colorado, United States