Multicystic Dysplastic Kidney study: Amnioinfusion
Official title Amnioinfusion for Fetal Renal Failure
ClinicalTrials.gov ID: NCT06728228
What this study is testing
- What it's testing
- The study wants to find out whether serial amnioinfusions can improve survival chances for fetuses with serious kidney issues that cause low amniotic fluid.
- Who it's for
- Pregnant people whose unborn baby has severe kidney problems that lead to low amniotic fluid.
- What's involved
- Participants will receive regular amnioinfusions, a procedure that adds fluid to the amniotic cavity, and will be monitored for effects on the fetus and mother.
- Time commitment
- The study involves multiple visits for infusions and monitoring over the course of the pregnancy.
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 is enrolling
- 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, but 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?
This study is enrolling now at Dallas, Texas, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.