No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
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Review the details below, then apply to join this clinical trial.
At a Glance
Sex
Any
Trial phase
Phase 1
Study type
Interventional
Purpose
Treatment
Participants needed
40 (estimated)
Sponsor
Mayo Clinic · Other
Who this trial is looking for
This trial is looking for pregnant women with certain severe conditions in their babies, like serious kidney issues or bladder problems. If you qualify, you may receive a treatment to help improve your baby's lung function and increase their chances of survival.
Are You a Good Fit for This Trial?
You may be able to join if
I am pregnant with a single baby
I am over 18 years old
My baby is less than 26 weeks old and has severe urinary obstruction
My baby is less than 26 weeks old and has no kidneys formed
My baby does not have chromosome abnormalities
My baby does not have other birth defects
I do not have Hepatitis B, Hepatitis C, or HIV
I can make decisions about my baby
You may not be able to join if
My baby has other unrelated birth defects
I am at high risk for early labor
There are known issues with my placenta
I have conditions that make surgery unsafe
I have declined invasive tests for my baby
I cannot meet the travel and follow-up requirements
I am involved in another study that affects my pregnancy
I have participated in this trial before
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
Congenital lower urinary tract obstruction (LUTO) is a heterogeneous group of congenital anomalies that lead bladder outlet obstruction. If a complete obstruction is present, the perinatal mortality is estimated to be as high as 90% because of severe pulmonary hypoplasia due to the lack of amniotic fluid. Survivors have significant risk of renal impairment (90%) requiring dialysis or renal transpl…
Congenital lower urinary tract obstruction (LUTO) is a heterogeneous group of congenital anomalies that lead bladder outlet obstruction. If a complete obstruction is present, the perinatal mortality is estimated to be as high as 90% because of severe pulmonary hypoplasia due to the lack of amniotic fluid. Survivors have significant risk of renal impairment (90%) requiring dialysis or renal transplantation if no fetal intervention is performed.
Renal agenesis is the congenital absence of one or both kidneys due to complete failure of the kidney to form. As many as 33% of fetuses with bilateral renal agenesis are stillborn, and the rest of them die immediately after birth due to severe pulmonary hypoplasia.
The objective of the serial amnioinfusions for fetuses with these conditions will be to reduce the severity of pulmonary hypoplasia (regenerating the lung functionality) and therefore increase the chance that the newborn survives to begin peritoneal dialysis. Although there is initial evidence that serial amnioinfusions are feasible for the pregnant women and the fetuses, there is still a need to have a prospective clinical trial to confirm the hypothesis that serial amnioinfusions could prevent severe pulmonary hypoplasia allowing the newborns with bilateral renal agenesis or severe LUTO to survive to begin peritoneal dialysis.
Therefore, the investigators aim to study the hypothesis that serial amnioinfusions for fetuses with severe LUTO and renal failure and those with bilateral renal agenesis will reduce the severity of pulmonary hypoplasia and therefore increase the chance that the newborn survives to begin peritoneal dialysis.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Pregnant women with singleton uterine pregnancy
* Maternal age \> age 18
* Fetus \< 26 weeks gestational age with severe LUTO and intrauterine renal failure
* Fetus \< 26 weeks gestational age with bilateral renal agenesis
* Fetus with absence of chromosome abnormalities
* Fet…
Inclusion Criteria:
* Pregnant women with singleton uterine pregnancy
* Maternal age \> age 18
* Fetus \< 26 weeks gestational age with severe LUTO and intrauterine renal failure
* Fetus \< 26 weeks gestational age with bilateral renal agenesis
* Fetus with absence of chromosome abnormalities
* Fetus with absence of associated anomalies
* Mother has negative Hepatitis B, Hepatitis C, and HIV testing
* Mother meets psychosocial criteria that allows her to make a conscious decision about her fetus/infant
Exclusion Criteria:
* Associated fetal anomaly unrelated to LUTO or renal agenesis
* Increased risk for preterm labor including short cervical length, history of incompetent cervix with or without cerclage, and previous preterm birth
* Placental abnormalities known at time of enrollment
* Maternal-fetal Rh isoimmunization, Kell sensitization or neonatal alloimmune thrombocytopenia affecting the current pregnancy
* Maternal medical condition that is a contraindication to surgery or anesthesia
* Mother has declined invasive testing
* Inability to comply with the travel and follow-up requirements of the trial
* Participation in another interventional study that influences maternal and fetal morbidity and mortality
* Participation in this clinical trial during a previous pregnancy
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