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Work Package - 3

Clinical Study Design

Design of the clinical study will be the objective. In addition we will collect information on severe early onset FGR pregnancies to allow comparison with treated pregnancies to study efficacy.

In addition, we will collect information as part of our prospective study about pregnancies affected by severe early onset FGR. This started in March 2014 and will give us information to help assess the safety of the maternal growth factor therapy during the clinical trial.

Objectives: To design the protocol for an uncontrolled, open-label, dose finding Phase I/II study to be performed in WP5, to agree data collection and create a database for WP5, to collate existing databases on the outcome of pregnancies affected by severe early onset FGR from four EU centres of excellence generating a database of historical controls for use in WP5.