Suspended

STRONGSubmersion Therapy for the Reversal of Oligohydramnios; A Non-invasive Gentle Approach

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What is being tested

IV/Oral Hydration and Bedrest

+ Hydrotherapy

DrugOther
Who is being recruted

Urogenital Diseases+1

+ Female Urogenital Diseases and Pregnancy Complications

+ Pregnancy Complications

Over 18 Years
+19 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: August 2012
See protocol details

Summary

Principal SponsorPediatrix
Last updated: March 30, 2020
Sourced from a government-validated database.Claim as a partner

Study start date: August 1, 2012

Actual date on which the first participant was enrolled.

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

Principal SponsorPediatrix
Last updated: March 30, 2020
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

4 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.


Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Female

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsPregnancy ComplicationsOligohydramnios

Criteria

5 inclusion criteria required to participate
Gestational age 24 - 36 weeks

Intact membranes

Maternal Age > 18 years

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

Show More Criteria

14 exclusion criteria prevent from participating
37 week gestation

BMI > 45

Fever ( > 38C)

Indication for urgent delivery (severe PET, HELLP syndrome, persistent fetal hypoxemia [non-reassuring fetal heart rate pattern])

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Active Comparator
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

Group II

Active Comparator
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

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Banner Good Samaritan Medical Center

Phoenix, United StatesOpen Banner Good Samaritan Medical Center in Google Maps
SuspendedOne Study Center