70
Participants
Start Date
December 21, 2018
Primary Completion Date
March 10, 2025
Study Completion Date
February 28, 2030
Serial amnioinfusions with isotonic fluid
Amnioinfusions will be performed by an expert in fetal procedures with a 20 or 22 gauge needle using sterile technique and ultrasound guidance. Local anesthetic will be employed. The fluid will consist of warmed isotonic fluid. Infusions may take up to 1 hour.
Spinal needle
A 20 or 22 gauge spinal needle will be used with sterile technique to access the uterus under ultrasound guidance and to infuse isotonic fluid.
Isotonic fluid
Isotonic fluids, including normal saline or lactated ringers solution, will be infused into the uterus through a spinal needle under ultrasound guidance using sterile technique. This fluid will act as replacement amniotic fluid.
Columbia University, New York
Children's Hospital of Philadelphia, Philadelphia
Johns Hopkins Hospital, Baltimore
Mayo Clinic, Rochester
University of Texas Health Science Center at Houston, Houston
University of Colorado Denver, Aurora
University of Southern California/Children's Hospital of Los Angeles/Huntington Hospital, Los Angeles
University of California San Francisco, San Francisco
Stanford University, Stanford
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NIH
Johns Hopkins University
OTHER