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Poor enrollment
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| Name | Class |
|---|---|
| Banner Health | OTHER |
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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.
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 of 10ml/wk at the beginning of the fetal period, this rate of expansion increases to 50-60ml/wk from 19 to 25wks at which time a gradual decrease begins to take place until the rate of exchange is zero around 34wks.
The pathophysiology of amniotic fluid regulation is not entirely understood at this current date, but it is safe to state that AFV is the integrated sums of the inflow and outflow tracts of the amniotic space.8 Because fluid can move with relative ease between fetal and maternal blood across the placenta and amniotic membranes it stands to reason that a maternal hypovolemia secondary to dehydration would lead to the development of oligohydramnios. This was indeed shown to be the case by Sherer, et al in their 1990 publication. Furthermore, both oral and serum hydration as a way to increase maternal volume have been shown to be effective treatments for oligohydramnios.3,11-16
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IV/Oral Hydration and Bedrest | Active Comparator |
ALL ITEMS ABOVE MUST BE COMPLETED BEFORE:
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| Hydrotherapy Group | Active Comparator |
ALL ITEMS ABOVE MUST BE COMPLETED BEFORE:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IV/Oral Hydration and Bedrest | Drug |
ALL ITEMS ABOVE MUST BE COMPLETED BEFORE:
|
| Measure | Description | Time Frame |
|---|---|---|
| 1. Primary: Number of Participants With Reversal of Oligohydramnios Using AFV Measures | Subjects amniotic fluid index via ultrasound on days 3, 5 and 7 of study participation. | days 3, and 7 or discharge |
| Measure | Description | Time Frame |
|---|---|---|
| Metabolic Status | Secondary: - Changes in maternal hemodynamic status by mobilizing extravascular fluid | admission, days 3, 5, 7/discharge and delivery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Thomas H Strong, MD | Obstetrix Medical Group | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Banner Good Samaritan Medical Center | Phoenix | Arizona | 85212 | United States |
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There were no pre-assignment events.
Recruitment began April 8, 2012 and ended April 2014. Recruitment took place at Banner Good Samaritan hospital based on Banner IRB approval.
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| ID | Title | Description |
|---|---|---|
| FG000 | IV/Oral Hydration and Bedrest | 1 Liter Water PO over 2 hours 1 Liter IV Fluid Bolus (NS) then titrated to 75 ml\hr for duration of the study participation Strict I/O's Vital signs US Procedures
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| FG001 | Hydrotherapy Group | US Procedures
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| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | IV/Oral Hydration and Bedrest | IV/Oral Hydration and Bedrest:
ALL ITEMS ABOVE MUST BE COMPLETED BEFORE:
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| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 1. Primary: Number of Participants With Reversal of Oligohydramnios Using AFV Measures | Subjects amniotic fluid index via ultrasound on days 3, 5 and 7 of study participation. | no formal analysis done on the 4 enrolled patients, study halted due to poor enrollment. Data cannot be reported due to participant privacy. | Posted | days 3, and 7 or discharge |
|
2 years and 4 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | IV/Oral Hydration and Bedrest |
ALL ITEMS ABOVE MUST BE COMPLETED BEFORE:
IV/Oral Hydration and Bedrest: • Maternal BP (sitting)
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ana Braescu | Mednax | 480-969-5999 | ana_braescu@mednax.com |
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| ID | Term |
|---|---|
| D016104 | Oligohydramnios |
| ID | Term |
|---|---|
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D001510 | Bed Rest |
| D006875 | Hydrotherapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D012046 | Rehabilitation |
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| Hydrotherapy | Other |
ALL ITEMS ABOVE MUST BE COMPLETED BEFORE:
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| BG001 | Hydrotherapy Group | • HYDROTHERAPY TWICE DAILY FOR 3-7 DAYS o Blood pressure, pulse, pulse pressure, body weight, and fetal heart rate before and after submersion therapy Hydrotherapy:
ALL ITEMS ABOVE MUST BE COMPLETED BEFORE:
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
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| OG001 | Hydrotherapy Group | HYDROTHERAPY TWICE DAILY FOR 3-7 DAYS
ALL ITEMS ABOVE MUST BE COMPLETED BEFORE:
Hydrotherapy: • Maternal BP (sitting)
|
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| Secondary | Metabolic Status | Secondary: - Changes in maternal hemodynamic status by mobilizing extravascular fluid | No analysis done as study halted for poor enrollment only 4 subjects enrolled total. Detailed Data cannot be reported due to participant privacy. | Posted | admission, days 3, 5, 7/discharge and delivery |
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| 0 |
| 2 |
| 0 |
| 2 |
| EG001 | Hydrotherapy Group |
ALL ITEMS ABOVE MUST BE COMPLETED BEFORE:
| 0 | 2 | 0 | 2 |
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