Funded CTSA Multisite Pilot Project

Childbirth is the most common reason for hospitalization in this country, yet data are limited regarding the effectiveness of treatment strategies for many serious, but uncommon, pregnancy complications. To address this gap, NIH-funded multidisciplinary researchers at five institutions have formed the National Perinatal Research Consortium (NPRC). The Consortium’s overarching goal is to conduct multicenter clinical trials and comparative effectiveness studies that will determine optimal management strategies for serious pregnancy complications.

The objective of this proposal is to develop a shared multidisciplinary research infrastructure among our five institutions and to demonstrate our capacity to collaborate in a pilot comparative effectiveness study of several rare obstetric events and their associated treatments.  We will collect data on cases of placenta accreta, monochorionic twins, maternal congenital heart disease, and mechanical ventilation during pregnancy, including both maternal and infant outcomes. Studying these rare conditions requires multidisciplinary collaboration among maternal-fetal medicine, OB/GYN, cardiology, critical care and neonatology specialists.

To achieve our objective, we will pursue three specific aims:

1)    Pilot a federated IRB model for clinical studies across our institutions;

2)    Develop and implement a shared multi-institutional RedCap database;

3)    Collect data on maternal and neonatal outcomes for these rare events, comparing outcomes among various management strategies used at our centers.

This project will result in important new evidence for optimal management of these morbid pregnancy complications, position our consortium to secure funding for future multisite clinical trials and comparative effectiveness studies, provide career development opportunities, and confirm our ability to collaborate through our respective CTSA centers.