P14.27: Ethics and ethical evaluation of a proposed clinical trial with maternal uterine artery vascular endothelial growth factor gene therapy to treat severe early‐onset fetal growth restriction in pregnant women

Abstract

Objectives:The purpose of this study was to determine the relationship between placental thickness and pregnancy outcomes in the third trimester. Methods: We conducted a retrospective study of 5,386 singleton pregnancies presenting for routine ultrasonography at 32 weeks' gestation between January 2010 and December 2011. Each placenta was measured to a 1 mm precision, at its greatest thickness, which was perpendicular to the uterine wall. Thick placenta was determined as placenta that was above the 90th percentile. Thin placenta was determined below the 10th percentile. The control group included pregnant women with placental thickness between the 10th and 90th percentile. We assessed newborn weight, incidence of SGA (small for gestational age) and LGA (large for gestational age), low birthweight, macrosomia, preterm birth, hypertensive disorders of pregnancy and gestational diabetes mellitus. Results: Overall mean placental thickness was 37.5mm. The cutoff value of thick placenta was 47mm, and thin placenta was 29mm. Gestational diabetes mellitus was significantly more common in the thick placenta group than control group (7.3% vs 4.5%, P = 0.018). Incidence of preterm birth was 8.0% in the thick placenta group, 4.8% in the thin placenta group and 3.9% in the control group (P = 0.001, P = 0.357, respectively). Mean birthweight was 3247gm in the thick placenta group, 3186gm in the thin placenta group and 3269gm in the control group (P = 0.331, P < 0.001). Incidence of small for gestational age below 10th percentile was 11.3% in the thick placenta group, 13.4% in the thin placenta group and 8.8% in the control group (P = 0.081, 0.007). Birthweight above 4000gm was 5.6%, 2.0% and 4.1%, respectively (P = 0.089, P = 0.007). Conclusions: Gestational diabetes mellitus and preterm birth were significantly more common in pregnant women with thick placenta. Thin placentas were significantly associated with a decreased newborn weight.Objectives: To describe maternal and fetal characteristics in pregnancies with UA AREDF and evaluate neonatal morbidity.

Maternal uterine artery VEGF gene therapy for treatment of intrauterine growth restriction

“…The consortium were awarded orphan drug status from the European Committee for Orphan Medicinal Products for FGR, the first time that a drug has been recognised for the treatment of FGR. In stakeholder and patient interviews conducted by the EVERREST consortium, maternal gene therapy was for the majority of stakeholders considered to be acceptable if there was clear fetal benefit (44). Most women felt they would be able to make informed decisions about taking part in such a trial whilst…”