Hydrotherapy for the Reversal of Oligohydraminos (STRONG)

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Obstetrix Medical Group
Sponsor:
Collaborator:
Banner Health
Information provided by (Responsible Party):
Ana Bodea Braescu, Obstetrix Medical Group
ClinicalTrials.gov Identifier:
NCT01682928
First received: September 6, 2012
Last updated: January 22, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention
Oligohydramnios
Drug: IV/Oral Hydration and Bedrest
Other: Hydrotherapy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Submersion Therapy for the Reversal of Oligohydramnios; A Non-invasive Gentle Approach

Further study details as provided by Obstetrix Medical Group:

Primary Outcome Measures:
  • 1. Primary: Reversal of oligohydramnios following subtotal immersion therapy using AFV measures [ Time Frame: Increased AFI by day 7 or discharge ] [ Designated as safety issue: No ]
    Subjects will have an ultrasound on days 3, 5 and 7 of study participation to check the amniotic fluid index.


Secondary Outcome Measures:
  • Metobolic status [ Time Frame: admission, days 3, 5, 7/discharge and delivery ] [ Designated as safety issue: No ]

    Secondary:

    - Changes in maternal hemodynamic status by mobilizing extravascular fluid



Estimated Enrollment: 120
Study Start Date: August 2012
Estimated Study Completion Date: February 2016
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 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})
  • 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})
  • 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
Active Comparator: Hydrotherapy Group
  • 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})

    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

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01682928

Locations
United States, Arizona
Banner Good Samaritan Medical Center Recruiting
Phoenix, Arizona, United States, 85212
Contact: Melissa Ingersoll, BSN    602-722-9564    mingersoll5@gmail.com   
Contact: Ana Bodea Braescu, MSN, MPH    602-257-8118 ext 135    ana_braescu@pediatrix.com   
Principal Investigator: Thomas H Strong, MD         
Sponsors and Collaborators
Obstetrix Medical Group
Banner Health
Investigators
Principal Investigator: Thomas H Strong, MD Obstetrix Medical Group
  More Information

No publications provided

Responsible Party: Ana Bodea Braescu, Research Nurse Coordinator, Obstetrix Medical Group
ClinicalTrials.gov Identifier: NCT01682928     History of Changes
Other Study ID Numbers: STRONG-2012
Study First Received: September 6, 2012
Last Updated: January 22, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Obstetrix Medical Group:
Oligohydramnios
Hydrotherapy
Pregnancy

Additional relevant MeSH terms:
Oligohydramnios
Pregnancy Complications

ClinicalTrials.gov processed this record on August 28, 2014