NCT06728228Recruiting
Amnioinfusion for Fetal Renal Failure
Source: ClinicalTrials.gov · Last updated 20 Dec 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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. The main questions this study aims to answer are: * Can serial amnioinfusion increase the chances of survival for these fetuses? * Does this procedure improve chances of survival until dialysis and/or kidney transplant? Participants will: * Receive regular amnioinfusions, which is a procedure that adds fluid to the amniotic cavity. * Undergo monitoring to check the effects on the fetus and mother. This study will help researchers understand if amnioinfusion is a useful treatment for fetal kidney problems and may provide valuable information for similar cases in the future.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 35 (estimated)
- First submitted
- 6 Dec 2024
- Start date
- 5 Dec 2024
- Primary completion date
- 15 Nov 2025
- Lead sponsor
- Fetal Care Center, PLLC
- Diseases
- Polycystic kidney disease
- NCT number
- NCT06728228
What you commit to
- Study type: Interventional
- Planned participants: 35
- From 5 Dec 2024 to the primary completion date, 15 Nov 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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).
- Severe maternal medical condition in pregnancy.
Other
- Cervix less than 2.5 cm in length.
- 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.
- Clinically diagnosed maternal depression, psychoses, or anxiety that are refractory to treatment.
- Technical limitations precluding amnioinfusion.
Who the study is looking for
- 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.
Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Fetal Care Center Coordinator of this site? Confirm its status | Dallas | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.