drugset / Trial / NCT01682928

Hydrotherapy for the Reversal of Oligohydramnios

NCT01682928

Terminated 4 enrolled Pediatrix Banner Health · collab
RandomizedParallel-groupOpen-labelTreatment

Summary

OBJECTIVE: To assess the efficacy of subtotal immersion therapy as an option to improve maternal intravascular volume thereby improving both maternal and fetal hemodynamic status with reversal of oligohydramnios. This will be measured utilizing the Amniotic Fluid Volume (AFV) as the primary outcome. Secondary outcomes will be measured using Fetal Doppler Studies, Maternal vital signs (Blood Pressure, Pulse Pressure, Weight, Pulse) and input/output. HYPOTHESIS: Oligohydramnios, secondary to depleted maternal intravascular volume, can be reversed by improving feto- and uteroplacental perfusion with subtotal immersion therapy.

Timeline

Start
2012-08
Primary completion
2014-12
Completion
2014-12

Drugs

EvaluationDrugModalityDoseRoute
Comparator IV/Oral Hydration and Bedrest Unknown 75 ml Intravenous
Comparator Salt and Water Unknown 1000 ml Oral

Indications