Womb surgery aims to save babies' kidneys and lungs
NCT ID NCT03281798
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This trial tests a procedure called fetal cystoscopy for unborn male babies with a severe blockage in the urinary tract (LUTO). Doctors insert a tiny telescope through the mother's belly into the baby's bladder to diagnose and treat the blockage with a laser. The study will enroll 10 pregnant women to see if the procedure can be done safely and help prevent serious lung and kidney problems after birth.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Fetal cystoscopy (a procedure using a fetoscope and laser to open blocked urinary tract in the womb)
- What this could lead to
- If successful, this procedure could help prevent severe lung and kidney damage in babies with this rare birth defect.
- What could go wrong
- This is a very small, early-stage trial with only 10 participants, so results may not apply widely. The procedure carries risks like preterm birth, infection, or fetal loss.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
-
About 10 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Jan 2018
- Expected to finish
-
Aug 2028
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
-
Female participants only
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Pregnant women 2. Singleton pregnancy 3. Maternal age ≥ 18 years 4. Male fetus with LUTO, dilated bladder, "keyhole sign" and bilateral hydronephrosis 5. Oligohydramnios or Anhydramnios 6. Favorable urine analysis defined as urinary sodium is \< 100 milliequivalents per liter (mEq/L), chloride \< 90 mEq/L, and osmolality \< 200 milliosmoles per kilogram (mOsm/kg) after 20 weeks and in the absence of previous in utero intervention for the disease (vesicoamniotic shunt placement or fetal cystoscopy). 7. Absence of chromosomal abnormalities and associated anomalies 8. Gestational age at the time of the procedure will be between 16 0/7 weeks and 25 6/7 weeks 9. Normal karyotype by invasive testing (amniocentesis or Chorionic Villus Sampling (CVS)). Patients declining invasive testing will be excluded. 10. Family have considered and declined the option of termination of the pregnancy at less than 24 weeks. 11. Family meets psychosocial criteria, including sufficient social support and ability to understand requirements of the study. 12. Parents or guardian are willing to provide signed informed consent. Exclusion Criteria: 1. Fetal anomaly unrelated to LUTO 2. Congenital cardiac anomaly 3. Female fetus 4. Increased risk for preterm labor including short cervical length (\<1.5 cm), history of incompetent cervix with or without cerclage, and previous preterm birth 5. Placental abnormalities (previa, abruption, accreta) known at time of enrollment 6. Contraindications to surgery including previous hysterotomy in active uterine segment 7. Technical limitations precluding fetoscopic surgery, such as uterine fibroids, fetal membrane separation, uterine anomalies incompatible with fetoscopy 8. Maternal-fetal Rh isoimmunization, Kell sensitization or neonatal alloimmune thrombocytopenia affecting the current pregnancy 9. Maternal HIV, Hepatitis-B, Hepatitis-C status positive because of the increased risk of transmission to the fetus during maternal-fetal surgery. If the patient's HIV or Hepatitis status is unknown, the patient must be tested and found to have negative results before enrollment 10. Maternal medical condition that is a contraindication to surgery or anesthesia 11. Patient does not have health insurance to cover routine clinical care including prenatal care, prenatal ultrasound, amniocentesis, tocolysis, admission, delivery, and fetal vesico-amniotic shunting. The exception will be fetal cystoscopy which is considered an experimental procedure. 12. Inability to comply with travel and follow-up requirements of the trial 13. Participation in another intervention study that influences maternal and fetal morbidity and mortality or participation in this trial in a previous pregnancy 14. Patients declining invasive testing 15. Family does not meet psychosocial criteria including insufficient
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Bladder outflow obstruction are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The places running it
1 site. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
-
Mayo Clinic
TERMINATEDRochester, Minnesota, 55905, United States
-
University of Miami
RECRUITINGMiami, Florida, 33136, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- A surgical twist that could save ejaculation during prostate surgery
- Laser vs bipolar: which surgery best tames an oversized prostate?
- New laser technique aims to prevent post-surgery bladder scarring in men with enlarged prostates
- Fetal surgery breakthrough: tiny camera could save Babies' bladders
- Botox shot during prostate op eases overactive bladder
- Double transplant: kidney and bladder together for the first time