Hydrotherapy for the Reversal of Oligohydramnios

Stopped early · Not applicable

Conditions studied: Oligohydramnios

In brief

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.

Key facts

Study ID

NCT01682928

Run by

Pediatrix

People needed

4

Starts

2012-08-01

Expected to finish

2014-12-01

Last updated by the study team

2020-03-30

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Maternal Age >18 years
• Oligohydramnios: diagnosed by sonography (defined AFV<8cm)
• Singleton Pregnancy
• Intact membranes
• Gestational age 24 - 36 weeks

You may not qualify if…

• Indication for urgent delivery (severe PET, HELLP syndrome, persistent fetal hypoxemia [non-reassuring fetal heart rate pattern])
• Ruptured amniotic membranes; PPROM, PROM, SROM
• Fever (>38C)
• Multiple gestation
• >37 week gestation
• Lethal Fetal anomalies and/or demise
• Maternal Cardiovascular disease
• Maternal Renal disease
• Maternal Pulmonary disease (other than asthma)
• Patients using prostaglandin inhibitors, NSAIDs3,15 (within 1 week of enrollment, other than baby asprin)
• Non-English speaking
• Vaginal Infections and/or active skin lesions
• Placenta Previa and/or Unexplained Vaginal Bleeding
• BMI > 45

Where it is running

• Banner Good Samaritan Medical Center — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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