Clinical Trial: Hydrotherapy for the Reversal of Oligohydramnios

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: Submersion Therapy for the Reversal of Oligohydramnios; A Non-invasive Gentle Approach

Brief 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.

Detailed Summary:

BACKGROUND: The volume of amniotic fluid is relevant clinically as derangements that decrease volume result in a condition known as oligohydramnios, which can have profound implications on perinatal outcome. The incidence of oligohydramnios is 2.3%1,2,3 and measurements of amniotic fluid volume (AFV) has become a standard in fetal surveillance in the evaluation of high risk pregnancies as oligohydramnios is associated with intrauterine growth restriction, respiratory distress syndrome, post-maturity syndrome, and chronic fetal hypoxia. Oligohydramnios may also play a role in fetal malpresentation, umbilical cord compression, meconium staining, and increased operative delivery.3,4, 5,6 Oligohydramnios is commonly defined as an AFV of 5 cm or less. An AFV of 8 cm represents the fifth percentile of normal AFV values.7 It has been observed that delivery in the setting of isolated oligohydramnios, irrespective of an otherwise uncomplicated term gestation free of maternal disease, has become routine thereby increasing maternal morbidity particularly in context of operative delivery or failed inductions. 3

In order to understand oligohydramnios it is first important to understand intrauterine water and progressive changes that occur with normal human gestation. At term, it is reported that total water accumulation is approximately 3.5L, with 2400 mL in the fetus, 400 mL in the placenta, and 700 mL in the amniotic fluid.8 In 1989, Brace and colleagues determined amniotic fluid volume (AFV) as a function of gestational age. They reported an increase in mean values from 30mL at 10weeks to 190mL at 16wks to 780mL at 32-35wks after which time AFV decreases, especially in post-term pregnancies. It is important to realize; however, that the pattern of volume fluctuation as a function of gestational age may vary considerably between individuals. As a general rule AFV increases at a rate
Sponsor: Mednax Center for Research, Education and Quality

Current Primary Outcome: 1. Primary: Reversal of oligohydramnios following subtotal immersion therapy using AFV measures [ Time Frame: Increased AFI by day 7 or discharge ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Metabolic status [ Time Frame: admission, days 3, 5, 7/discharge and delivery ]

Original Secondary Outcome: Metobolic status [ Time Frame: admission, days 3, 5, 7/discharge and delivery ]

Information By: Mednax Center for Research, Education and Quality

Dates:
Date Received: September 6, 2012
Date Started: August 2012
Date Completion:
Last Updated: November 22, 2016
Last Verified: November 2016