Early pregnancy renal anhydramnios or EPRA is a condition where a pregnant woman does not
have any amniotic fluid around her fetus because of a problem with the fetus's kidneys. This
condition is thought to be fatal once the fetus is born because of inadequate lung growth.
The Renal Anhydramnios Fetal Therapy (RAFT) Trial offers eligible pregnant women with a
diagnosis of EPRA an experimental therapy of repeated or serial "amnioinfusions" of fluid
into the womb. An amnioinfusion involves placing a small needle through the pregnant woman's
skin into the womb next to the fetus. Warm sterile fluid with balanced electrolytes and
antibiotics is then slowly infused into amniotic space inside the womb. The aim is to help
the fetus's lungs grow enough so he or she can survive after birth. These amnioinfusions will
be carried out by an expert in fetal interventions at a RAFT center. There is a significant
risk of early rupture of membranes and early delivery in subjects who receive amnioinfusions,
and any potential trial participants will be counseled about these risks before they decide
whether to join the trial. Any eligible patients who, after counseling, elect to terminate
the pregnancy will not be eligible to participate in the trial. All eligible patients who
choose to join the RAFT trial will be able to choose their assignment into one of two arms of
the study: (1) to receive serial amnioinfusions (2) to not receive amnioinfusions but receive
monitoring for the remainder of the pregnancy at the RAFT center. Thus, assignment of
patients to study arm will not be random, but will be decided by the participant. Fetuses who
do survive after birth will require intensive medical management for kidney failure including
placement of a dialysis catheter and dialysis therapy with the eventual need for a kidney
transplant. Treatment for lung disease secondary to abnormal lung development may also be
required. The study will follow babies and their families until non-survival or transplant.