BridgeMD
New treatment option for Multicystic Dysplastic Kidney
Official title Amnioinfusion for Fetal Renal Failure
ClinicalTrials.gov ID: NCT06728228
What this study is testing
- What it's testing
- The goal of this clinical trial is to learn if serial amnioinfusions can improve the chances of survival for fetuses with severe kidney problems that cause low amniotic fluid (anhydramnios). Low amniotic fluid can affect lung development and may lead to serious health issues for the fetus.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Adults, women only
You may be able to join if
- Confirmed anhydramnios before 22 weeks GA for patients with FRF.
- Consent is signed and first therapeutic amnioinfusion can and does occur before 28 weeks and 6/7 days GA.
- Confirmation that the expectant mother understands her options for management of the pregnancy.
- Age ≥18 years of age.
- Willingness to be followed by the Fetal Care Center at Dallas and deliver at Medical City Dallas.
You likely can't join if
- Cervix less than 2.5 cm in length.
- No fatal findings on Karyotype (e.g trisomy 13, or 18) or Microarray fatal findings excluding those that are related to pulmonary hypoplasia due to...
- Other significant congenital anomalies in the fetus.
- Evidence of chorioamnionitis or abruptio placentae.
- Evidence of rupture of membranes or chorionic-amniotic separation.
- Evidence of preterm labor.
See the full eligibility criteria
- Confirmed anhydramnios before 22 weeks GA for patients with FRF.
- Consent is signed and first therapeutic amnioinfusion can and does occur before 28 weeks and 6/7 days GA.
- Confirmation that the expectant mother understands her options for management of the pregnancy.
- Age ≥18 years of age.
- Willingness to be followed by the Fetal Care Center at Dallas and deliver at Medical City Dallas.
- Willingness for postnatal care to be performed at Medical City Dallas Hospital/the Fetal Care Center until maternal discharge.
- Consults with Pediatric Nephrology, Neonatology, Transplant Surgery, Pediatric surgery, Maternal-Fetal Medicine Specialist, and a Genetic Counselor.
- Cervix less than 2.5 cm in length.
- No fatal findings on Karyotype (e.g trisomy 13, or 18) or Microarray fatal findings excluding those that are related to pulmonary hypoplasia due to fetal renal failure (e.g. Meckel-Gruber, PCKD).
- Other significant congenital anomalies in the fetus.
- Evidence of chorioamnionitis or abruptio placentae.
- Evidence of rupture of membranes or chorionic-amniotic separation.
- Evidence of preterm labor.
- Multiple gestation.
- Severe maternal medical condition in pregnancy.
- Clinically diagnosed maternal depression, psychoses, or anxiety that are refractory to treatment.
- Technical limitations precluding amnioinfusion.
The study team makes the final eligibility decision.
Where it's taking place
- Dallas, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, not specified. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Dallas, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.