The Renal Anhydramnios Fetal Therapy (RAFT) study is testing an experimental treatment for mothers and their babies affected by Early Pregnancy Renal Anhydramnios (EPRA). The study seeks to determine whether repeated injections of fluid (amnioinfusions) into the uterus can reverse the effects of EPRA such that affected babies have enough lung function to survive outside the womb.
What is EPRA?
Early Pregnancy Renal Anhydramnios is a condition where a pregnant woman does not have amniotic fluid around her fetus (baby) because of problems with the baby’s renal system. EPRA occurs when the baby’s kidneys, ureters, bladder, or urethra fail to properly develop, interfering with the baby’s ability to make or pass urine. After 16 weeks of pregnancy, the baby’s urine contributes more than 90% of the amniotic fluid around the baby. Amniotic fluid is essential for normal lung development in the baby. Untreated EPRA is considered universally fatal.
What are bilateral renal agenesis and fetal renal failure?
Bilateral renal agenesis (BRA) is a congenital condition in which the kidneys do not develop. In contrast, with fetal renal failure (FRF) the kidneys are present but fail to make urine. FRF can result from a genetic condition or a blockage of urine exiting the bladder, which damage the kidneys. Bilateral renal agenesis and FRF occur in at least 1 in 3000 pregnancies. Diagnosis ismade on prenatal ultrasound or MRI. These conditions can occur in isolation or with other fetal anomalies.
Why is this study important?
Both of these conditions can lead to persistent absence of amniotic fluid (anhydramnios) and, in turn, underdeveloped fetal lungs. If anhydramnios occurs early in the pregnancy, infants may not survive without prenatal intervention.
Who may enroll in the study?
Fetuses with the following diagnoses are eligible:
- Bilateral renal agenesis
- Bilateral multidysplastic kidneys
- Lower Urinary Tract Obstruction (LUTO) with kidney failure
- Anhydramnios before 22 wks or confirmed bilateral renal agenesis
- First amnioinfusion before 26 wks 0 days
- Maternal age ≥ 18 years
- Willingness to be followed, deliver, and receive infant care at a RAFT Center
- Cervical length <2.5 cm
- Abnormal karyotype or microarray (significant pathogenic or likely pathogenic findings)
- Other significant congenital anomalies
- Chorioamnionitis or abruptio placentae
- Rupture of membranes or chorioamniotic separation
- Preterm labor
- Multiple gestation
- Severe maternal medical condition
- Maternal depression that is refractory to treatment
- Technical limitations precluding amnioinfusion
Participants may enroll in this study during pregnancy. If the fetal diagnosis is confirmed and the above criteria are met, parents can choose one of the following enrollment groups:
- Receive serial amnioinfusions (intervention)
- Observation throughout pregnancy (expectant management)
The known potential benefits for the participant who choose intervention is the possible survival of their baby from an otherwise fatal disease. For parents who wish to continue a pregnancy, this intervention may be the only way to prevent lethal respiratory failure.
Those parents that wish to participate in the study but not undergo fetal treatment will be providing important information by enrolling in the control group. These study participants could benefit patients who carry a fetus with BRA or FRF in the future.
Successful completion of this study could make this therapy available to all pregnancies complicated by fetal BRA or FRF. Furthermore, this study may be applicable to other fetal diseases in which there is a low amniotic fluid level and a risk of pulmonary hypoplasia.
What can I expect if I enroll in the study?
Each enrollment group, intervention and expectant management, will be closely monitored. Each visit is important so those enrolled in the study will be asked to transfer prenatal care to the RAFT center. Relocation near the RAFT center (within 30 minutes) for the duration of the pregnancy after 26 weeks and delivery, is also required. Consecutive follow up appointments
and counseling provided by specialists, are essential to the surveillance of both groups. The intervention will consist of serial amnioinfusions, of which its effectiveness will be measured throughout the pregnancy and postnatal follow-up assessments. The financial and logistical challenges will also be discussed.
How can I participate?
If you would like to participate in the study, please either email our study team at [email protected] or call 1-800-RX-FETUS. Additional information may be found on the trial website http://raft-trial.org.
Dr. Juan Gonzalez
Dr. Anita Moon-Grady
Dr. Paul Brakeman
Dr. Mark Sugi