A request for applications (RFA) is proposed entitled: Eunice Kennedy Shriver NICHD Maternal Fetal Medicine Units Network. This proposed RFA will use the cooperative agreement mechanism. This network receives support from other Institutes for studies. Currently, NHLBI funding supports a RCT on Antenatal Late Preterm Steroids and NINDS co-funds a RCT of Thyroxine Therapy for Subclinical Hypothyroidism or Hypothyroxinemia Diagnosed During Pregnancy.
Purpose
The purpose of this request is to re-compete the clinical centers for the Maternal Fetal Medicine Units Network. The network consists of clinical sites, an independent datacenter along with NICHD to perform clinical trials and observational research. The goal of the Maternal Fetal Medicine Units Network is to conduct multi-center clinical research designed to investigate problems in clinical obstetrics, particularly those related to prevention of preterm birth, low birth weight, and medical problems of pregnancy. By establishing a network of academic centers using rigorous patient evaluation and common protocols, the required numbers of patients can be studied to provide answers more rapidly than individual centers acting alone. The infrastructure is set up to conduct the ideal randomized double-blinded placebo controlled trial as well as observational studies in obstetrics.
Scope
Proposals considered responsive to this solicitation include clinical centers with academically-oriented divisions of maternal fetal medicine and a minimum of 3,000 births per year with a minimum of 30 percent documented to be high risk pregnancies. The study site must have an established perinatal data system, and a full time clinical research coordinator. The ambulatory facilities for prenatal care, postpartum care and neonatal follow-up and procedures for conducting clinical research in these facilities should be established. There also has to be an institutional pharmacy capable of supporting clinical research. Clinical sites will be required to propose a concept protocol for implementation at all of the network sites. Specifically, the network will continue to conduct prospective randomized trials of obstetric interventions and observational studies of high risk cohorts. The proposed network would include 11-14 clinical sites, an independent data-coordinating center funded for five years in 2013, and NICHD.
Objective
The objective of this concept is to foster multicenter clinical trials in obstetrics. The infrastructure is set up for randomized double-blind placebo controlled trials with the ability to follow short term (clinical effect) and long term infant and maternal outcomes. The goal of the Maternal Fetal Medicine Units Network is to advance the field by establishing and maintaining a network of academic centers that perform multi-center clinical trials in a rigorous manner to assess safety and efficacy of treatment and management strategies in obstetrics.
Program Contact
John Ilekis, PhD
Pregnancy and Perinatology Branch
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