An interventional study of IV/Oral Hydration and Bedrest and Hydrotherapy in Oligohydramnios, sponsored by Pediatrix. Terminated at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-03-30.
Sponsored by Pediatrix · Not applicable, Interventional, and Treatment
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
25 studies on the registry are indexed under Oligohydramnios; 5 are open to participants now.
This study's enrollment of 4 is below the median of 91 across 16 interventional studies indexed under Oligohydramnios.
Browse Oligohydramnios studies →Pediatrix is the lead sponsor of 34 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
* Maternal BP (sitting) * Pulse Pressure * Pulse * Urine Specific Gravity BID * Fetal Heart Rate * Maternal Body Weight US Procedures * AC/EFW * Umbilical Artery Doppler Flow (Baseline, day 3, 7 {or Discharge}) * Uterine Artery Doppler Flow (Baseline, day 3, 7 {or Discharge}) * AFI (Baseline, day 3, 7 {or Discharge}) ALL ITEMS ABOVE MUST BE COMPLETED BEFORE: * 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
Drug: IV/Oral Hydration and Bedrest
* Maternal BP (sitting) * Pulse Pressure * Pulse * Urine Specific Gravity BID * Fetal Heart Rate * Maternal Body Weight US Procedures * AC/EFW * Umbilical Artery Doppler Flow (Baseline, day 3, 7 {or Discharge}) o 1 hour +/- 30 minutes after submersion therapy * Uterine Artery Doppler Flow (Baseline, day 3, 7 {or Discharge}) o 1 hour +/- 30 minutes after submersion therapy * AFI (Baseline, day 3, 7 {or Discharge}) o 1 hour +/- 30 minutes after submersion therapy ALL ITEMS ABOVE MUST BE COMPLETED BEFORE: * 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 * HYDROTHERAPY TWICE DAILY FOR 3-7 DAYS o Blood pressure, pulse, pulse pressure, body weight, and fetal heart rate before and after submersion therapy
Other: Hydrotherapy
* Maternal BP (sitting) * Pulse Pressure * Pulse * Urine Specific Gravity BID * Fetal Heart Rate * Maternal Body Weight US Procedures * AC/EFW * Umbilical Artery Doppler Flow (Baseline, day 3, 7 {or Discharge}) * Uterine Artery Doppler Flow (Baseline, day 3, 7 {or Discharge}) * AFI (Baseline, day 3, 7 {or Discharge}) ALL ITEMS ABOVE MUST BE COMPLETED BEFORE: * 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
* Maternal BP (sitting) * Pulse Pressure * Pulse * Urine Specific Gravity BID * Fetal Heart Rate * Maternal Body Weight US Procedures * AC/EFW * Umbilical Artery Doppler Flow (Baseline, day 3, 7 {or Discharge}) o 1 hour +/- 30 minutes after submersion therapy * Uterine Artery Doppler Flow (Baseline, day 3, 7 {or Discharge}) o 1 hour +/- 30 minutes after submersion therapy * AFI (Baseline, day 3, 7 {or Discharge}) o 1 hour +/- 30 minutes after submersion therapy ALL ITEMS ABOVE MUST BE COMPLETED BEFORE: * 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 * HYDROTHERAPY TWICE DAILY FOR 3-7 DAYS o Blood pressure, pulse, pulse pressure, body weight, and fetal heart rate before and after submersion therapy
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.
Time frame: days 3, and 7 or discharge
Metabolic Status
Secondary: - Changes in maternal hemodynamic status by mobilizing extravascular fluid
Time frame: admission, days 3, 5, 7/discharge and delivery
Recruitment began April 8, 2012 and ended April 2014. Recruitment took place at Banner Good Samaritan hospital based on Banner IRB approval.
| Milestone | IV/Oral Hydration and Bedrest | Hydrotherapy Group |
|---|---|---|
| Started | 2 | 2 |
| Completed | 2 | 2 |
| Not completed | 0 | 0 |
Subjects amniotic fluid index via ultrasound on days 3, 5 and 7 of study participation.
No measurements were reported for this outcome.
Secondary: - Changes in maternal hemodynamic status by mobilizing extravascular fluid
No measurements were reported for this outcome.
Collected over 2 years and 4 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| IV/Oral Hydration and Bedrest | — | 0/2 (0%) | 0/2 (0%) |
| Hydrotherapy Group | — | 0/2 (0%) | 0/2 (0%) |
| Age, Categorical(Participants) | IV/Oral Hydration and Bedrest | Hydrotherapy Group | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 2 | 2 | 4 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | IV/Oral Hydration and Bedrest | Hydrotherapy Group | Total |
|---|---|---|---|
| Mean | 31.5 (29 to 34) | 23 (21 to 25) | 27.25 (21 to 34) |
| Sex: Female, Male(Participants) | IV/Oral Hydration and Bedrest | Hydrotherapy Group | Total |
|---|---|---|---|
| Female | 2 | 2 | 4 |
| Male | 0 | 0 | 0 |
| Ethnicity (NIH/OMB)(Participants) | IV/Oral Hydration and Bedrest | Hydrotherapy Group | Total |
|---|---|---|---|
| Hispanic or Latino | 1 | 0 | 1 |
| Not Hispanic or Latino | 1 | 2 | 3 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | IV/Oral Hydration and Bedrest | Hydrotherapy Group | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 1 | 1 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 1 | 0 | 1 |
| White | 1 | 1 | 2 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(Participants) | IV/Oral Hydration and Bedrest | Hydrotherapy Group | Total |
|---|---|---|---|
| United States | 2 | 2 | 4 |
Plan to share: No
No publications or documents are linked to this record.
The record gives a start of Aug 2012, a primary completion of Dec 2014 and a completion of Dec 2014. It does not say whether these dates are actual or estimated.
Results were first posted in Mar 2020, 5 years 3 months after primary completion.
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This study is terminated, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.
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