Placental Lesions in Fetal Growth Restrictions

• Status: Completed
• Trial end date: 2021-10-06
• Target enrollment: 0
• Participant gender: Female

Summary

The purpose of this research study is to develop imaging methods to diagnose placental injury in pregnancies diagnosed with fetal growth restriction (FGR). Investigators are doing this research because the use of IV iron, followed by a Magnetic resonance imaging (MRI), may help detect injury in the placenta. The IV iron, ferumoxytol, is an iron preparation used for treatment of iron deficiency anemia. It is given in hospital setting under close medical attention. Ferumoxytol(FE) is FDA approved for some uses, but in pregnant women, its use as a MRI contrast is investigational.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Wisconsin, Madison
• Collaborator: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Treatments: Ferrosoferric Oxide

Criteria

Inclusion Criteria:

• Pregravid Body Mass Index (BMI) 18.5-39.9 kg/M2

• Women with singleton pregnancies

• Ultrasound confirmed pregnancy dating prior to 14 weeks gestation

• Gestational age of 27 0/7 - 32 6/7 weeks at FGR diagnosis based on standard clinical criteria: Either estimated fetal weight (EFW) less than 10 percentile OR abdominal circumference less than 10th percentile

Exclusion Criteria:

• Diagnosis of preeclampsia at FGR diagnosis

• Gestational Diabetes Mellitus or type I/II Diabetes Mellitus

• Known fetal chromosome abnormality, structural malformation or syndromes in current pregnancy

• Known fetal viral infection syndrome

• Alcohol/drug use in current pregnancy

• History of sickle cell anemia, sickle cell trait or other inherited anemia with risk of iron overload

• Contraindications to MRI (such as claustrophobia, metallic implant, etc.) based on MRI Screening

• Participation in other interventional clinical trials, including those with other investigational agents not included in this trial, within 30 days of the start of this trial and throughout the duration of this trial

• Any physical or psychological symptom, based on the clinical judgment of the study physician that would make a participant unsuitable for the study.