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Hydrotherapy for the Reversal of Oligohydramnios (STRONG)

Primary Purpose

Oligohydramnios

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
IV/Oral Hydration and Bedrest
Hydrotherapy
Sponsored by
Pediatrix
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Oligohydramnios focused on measuring Oligohydramnios, Hydrotherapy, Pregnancy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Banner Good Samaritan Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

IV/Oral Hydration and Bedrest

Hydrotherapy Group

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Metabolic Status
Secondary: - Changes in maternal hemodynamic status by mobilizing extravascular fluid

Full Information

First Posted
September 6, 2012
Last Updated
March 27, 2020
Sponsor
Pediatrix
Collaborators
Banner Health
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1. Study Identification

Unique Protocol Identification Number
NCT01682928
Brief Title
Hydrotherapy for the Reversal of Oligohydramnios
Acronym
STRONG
Official Title
Submersion Therapy for the Reversal of Oligohydramnios; A Non-invasive Gentle Approach
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Terminated
Why Stopped
Poor enrollment
Study Start Date
August 2012 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pediatrix
Collaborators
Banner Health

4. Oversight

Data Monitoring Committee
No

5. Study Description

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 Description
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oligohydramnios
Keywords
Oligohydramnios, Hydrotherapy, Pregnancy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
4 (Actual)

8. Arms, Groups, and Interventions

Arm Title
IV/Oral Hydration and Bedrest
Arm Type
Active Comparator
Arm Description
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
Arm Title
Hydrotherapy Group
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
IV/Oral Hydration and Bedrest
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Hydrotherapy
Intervention Description
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
Primary Outcome Measure Information:
Title
1. Primary: Number of Participants With Reversal of Oligohydramnios Using AFV Measures
Description
Subjects amniotic fluid index via ultrasound on days 3, 5 and 7 of study participation.
Time Frame
days 3, and 7 or discharge
Secondary Outcome Measure Information:
Title
Metabolic Status
Description
Secondary: - Changes in maternal hemodynamic status by mobilizing extravascular fluid
Time Frame
admission, days 3, 5, 7/discharge and delivery

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas H Strong, MD
Organizational Affiliation
Obstetrix Medical Group
Official's Role
Principal Investigator
Facility Information:
Facility Name
Banner Good Samaritan Medical Center
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85212
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Hydrotherapy for the Reversal of Oligohydramnios

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