Using amnioinfusions to treat pulmonary hypoplasia in fetuses

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to evaluate the effectiveness of serial amnioinfusions in fetuses diagnosed with severe lower urinary tract obstruction (LUTO) or bilateral renal agenesis. The study will involve pregnant women with affected fetuses who will receive ultrasound-guided amnioinfusions to increase amniotic fluid levels, potentially reducing the severity of pulmonary hypoplasia. The trial will enroll a limited number of participants due to the rarity of these conditions, with a focus on monitoring outcomes over a two-year period. The goal is to assess whether this intervention can improve survival rates and renal function in newborns.

Why it matters

Who can join: the full rules

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

Where it's running

• Mayo Clinic
  Rochester, Minnesota, United States Recruiting

Study contacts

• Principal investigator: Mauro Schenone, MD — Mayo Clinic
• Study coordinator: Taylor M Rasmusson, MSN
• Email: Rasmusson.Taylor@mayo.edu
• Phone: 507-266-4813

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Amnioinfusion to help fetuses with kidney problems

  This study is testing if giving extra fluid to pregnant women with fetuses that have serious kidney problems can help improve the babies' chances of survival and healthy development.

  Recruiting Fetal Care Center, PLLC · Dallas, Texas · NCT06728228

• Examining the link between urine proteins and urinary symptoms in men with prostate enlargement

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• Fetal cystoscopy to unblock severe bladder outlet obstruction before birth

  This procedure will try fetal cystoscopy in pregnant women carrying a male fetus with severe lower urinary tract obstruction and low amniotic fluid to see if it improves fetal kidney function and chances of survival.

  Recruiting University of Miami · Miami, Florida and 1 other locations · NCT03281798

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.