Hydrotherapy for the Reversal of Oligohydramnios

• Status: Terminated
• Trial end date: 2014-12-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mednax Center for Research, Education and Quality; Mednax Center for Research, Education, Quality and Safety
• Collaborator: Banner Health

Criteria

Inclusion Criteria:

• Maternal Age >18 years

• Oligohydramnios: diagnosed by sonography (defined AFV<8cm)

• Singleton Pregnancy

• Intact membranes

• Gestational age 24 - 36 weeks

Exclusion Criteria:

• 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