<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01682928</url>
  </required_header>
  <id_info>
    <org_study_id>STRONG-2012</org_study_id>
    <nct_id>NCT01682928</nct_id>
  </id_info>
  <brief_title>Hydrotherapy for the Reversal of Oligohydramnios</brief_title>
  <acronym>STRONG</acronym>
  <official_title>Submersion Therapy for the Reversal of Oligohydramnios; A Non-invasive Gentle Approach</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Pediatrix</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Banner Health</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Pediatrix</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      OBJECTIVE: To assess the efficacy of subtotal immersion therapy as an option to improve&#xD;
      maternal intravascular volume thereby improving both maternal and fetal hemodynamic status&#xD;
      with reversal of oligohydramnios. This will be measured utilizing the Amniotic Fluid Volume&#xD;
      (AFV) as the primary outcome. Secondary outcomes will be measured using Fetal Doppler&#xD;
      Studies, Maternal vital signs (Blood Pressure, Pulse Pressure, Weight, Pulse) and&#xD;
      input/output.&#xD;
&#xD;
      HYPOTHESIS: Oligohydramnios, secondary to depleted maternal intravascular volume, can be&#xD;
      reversed by improving feto- and uteroplacental perfusion with subtotal immersion therapy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      BACKGROUND: The volume of amniotic fluid is relevant clinically as derangements that decrease&#xD;
      volume result in a condition known as oligohydramnios, which can have profound implications&#xD;
      on perinatal outcome. The incidence of oligohydramnios is 2.3%1,2,3 and measurements of&#xD;
      amniotic fluid volume (AFV) has become a standard in fetal surveillance in the evaluation of&#xD;
      high risk pregnancies as oligohydramnios is associated with intrauterine growth restriction,&#xD;
      respiratory distress syndrome, post-maturity syndrome, and chronic fetal hypoxia.&#xD;
      Oligohydramnios may also play a role in fetal malpresentation, umbilical cord compression,&#xD;
      meconium staining, and increased operative delivery.3,4, 5,6 Oligohydramnios is commonly&#xD;
      defined as an AFV of 5 cm or less. An AFV of 8 cm represents the fifth percentile of normal&#xD;
      AFV values.7 It has been observed that delivery in the setting of isolated oligohydramnios,&#xD;
      irrespective of an otherwise uncomplicated term gestation free of maternal disease, has&#xD;
      become routine thereby increasing maternal morbidity particularly in context of operative&#xD;
      delivery or failed inductions. 3&#xD;
&#xD;
      In order to understand oligohydramnios it is first important to understand intrauterine water&#xD;
      and progressive changes that occur with normal human gestation. At term, it is reported that&#xD;
      total water accumulation is approximately 3.5L, with 2400 mL in the fetus, 400 mL in the&#xD;
      placenta, and 700 mL in the amniotic fluid.8 In 1989, Brace and colleagues determined&#xD;
      amniotic fluid volume (AFV) as a function of gestational age. They reported an increase in&#xD;
      mean values from 30mL at 10weeks to 190mL at 16wks to 780mL at 32-35wks after which time AFV&#xD;
      decreases, especially in post-term pregnancies. It is important to realize; however, that the&#xD;
      pattern of volume fluctuation as a function of gestational age may vary considerably between&#xD;
      individuals. As a general rule AFV increases at a rate of 10ml/wk at the beginning of the&#xD;
      fetal period, this rate of expansion increases to 50-60ml/wk from 19 to 25wks at which time a&#xD;
      gradual decrease begins to take place until the rate of exchange is zero around 34wks.&#xD;
&#xD;
      The pathophysiology of amniotic fluid regulation is not entirely understood at this current&#xD;
      date, but it is safe to state that AFV is the integrated sums of the inflow and outflow&#xD;
      tracts of the amniotic space.8 Because fluid can move with relative ease between fetal and&#xD;
      maternal blood across the placenta and amniotic membranes it stands to reason that a maternal&#xD;
      hypovolemia secondary to dehydration would lead to the development of oligohydramnios. This&#xD;
      was indeed shown to be the case by Sherer, et al in their 1990 publication. Furthermore, both&#xD;
      oral and serum hydration as a way to increase maternal volume have been shown to be effective&#xD;
      treatments for oligohydramnios.3,11-16&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Poor enrollment&#xD;
  </why_stopped>
  <start_date>August 2012</start_date>
  <completion_date type="Actual">December 2014</completion_date>
  <primary_completion_date type="Actual">December 2014</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>1. Primary: Number of Participants With Reversal of Oligohydramnios Using AFV Measures</measure>
    <time_frame>days 3, and 7 or discharge</time_frame>
    <description>Subjects amniotic fluid index via ultrasound on days 3, 5 and 7 of study participation.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Metabolic Status</measure>
    <time_frame>admission, days 3, 5, 7/discharge and delivery</time_frame>
    <description>Secondary:&#xD;
- Changes in maternal hemodynamic status by mobilizing extravascular fluid</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">4</enrollment>
  <condition>Oligohydramnios</condition>
  <arm_group>
    <arm_group_label>IV/Oral Hydration and Bedrest</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Maternal BP (sitting)&#xD;
Pulse Pressure&#xD;
Pulse&#xD;
Urine Specific Gravity BID&#xD;
Fetal Heart Rate&#xD;
Maternal Body Weight US Procedures&#xD;
AC/EFW&#xD;
Umbilical Artery Doppler Flow (Baseline, day 3, 7 {or Discharge})&#xD;
Uterine Artery Doppler Flow (Baseline, day 3, 7 {or Discharge})&#xD;
AFI (Baseline, day 3, 7 {or Discharge})&#xD;
ALL ITEMS ABOVE MUST BE COMPLETED BEFORE:&#xD;
1 Liter Water PO over 2 hours&#xD;
1 Liter IV Fluid Bolus (NS) then titrated to 75 ml\hr for duration of the study participation&#xD;
Strict I/O's&#xD;
Vital signs</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Hydrotherapy Group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Maternal BP (sitting)&#xD;
Pulse Pressure&#xD;
Pulse&#xD;
Urine Specific Gravity BID&#xD;
Fetal Heart Rate&#xD;
Maternal Body Weight US Procedures&#xD;
AC/EFW&#xD;
Umbilical Artery Doppler Flow (Baseline, day 3, 7 {or Discharge})&#xD;
o 1 hour +/- 30 minutes after submersion therapy&#xD;
Uterine Artery Doppler Flow (Baseline, day 3, 7 {or Discharge})&#xD;
o 1 hour +/- 30 minutes after submersion therapy&#xD;
AFI (Baseline, day 3, 7 {or Discharge}) o 1 hour +/- 30 minutes after submersion therapy&#xD;
ALL ITEMS ABOVE MUST BE COMPLETED BEFORE:&#xD;
1 Liter Water PO over 2 hours&#xD;
1 Liter IV Fluid Bolus (NS) then titrated to 75 ml\hr for duration of the study participation&#xD;
Strict I/O's&#xD;
Vital signs&#xD;
HYDROTHERAPY TWICE DAILY FOR 3-7 DAYS o Blood pressure, pulse, pulse pressure, body weight, and fetal heart rate before and after submersion therapy</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>IV/Oral Hydration and Bedrest</intervention_name>
    <description>Maternal BP (sitting)&#xD;
Pulse Pressure&#xD;
Pulse&#xD;
Urine Specific Gravity BID&#xD;
Fetal Heart Rate&#xD;
Maternal Body Weight US Procedures&#xD;
AC/EFW&#xD;
Umbilical Artery Doppler Flow (Baseline, day 3, 7 {or Discharge})&#xD;
Uterine Artery Doppler Flow (Baseline, day 3, 7 {or Discharge})&#xD;
AFI (Baseline, day 3, 7 {or Discharge})&#xD;
ALL ITEMS ABOVE MUST BE COMPLETED BEFORE:&#xD;
1 Liter Water PO over 2 hours&#xD;
1 Liter IV Fluid Bolus (NS) then titrated to 75 ml\hr for duration of the study participation&#xD;
Strict I/O's&#xD;
Vital signs</description>
    <arm_group_label>IV/Oral Hydration and Bedrest</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Hydrotherapy</intervention_name>
    <description>Maternal BP (sitting)&#xD;
Pulse Pressure&#xD;
Pulse&#xD;
Urine Specific Gravity BID&#xD;
Fetal Heart Rate&#xD;
Maternal Body Weight US Procedures&#xD;
AC/EFW&#xD;
Umbilical Artery Doppler Flow (Baseline, day 3, 7 {or Discharge})&#xD;
o 1 hour +/- 30 minutes after submersion therapy&#xD;
Uterine Artery Doppler Flow (Baseline, day 3, 7 {or Discharge})&#xD;
o 1 hour +/- 30 minutes after submersion therapy&#xD;
AFI (Baseline, day 3, 7 {or Discharge}) o 1 hour +/- 30 minutes after submersion therapy&#xD;
ALL ITEMS ABOVE MUST BE COMPLETED BEFORE:&#xD;
1 Liter Water PO over 2 hours&#xD;
1 Liter IV Fluid Bolus (NS) then titrated to 75 ml\hr for duration of the study participation&#xD;
Strict I/O's&#xD;
Vital signs&#xD;
HYDROTHERAPY TWICE DAILY FOR 3-7 DAYS o Blood pressure, pulse, pulse pressure, body weight, and fetal heart rate before and after submersion therapy</description>
    <arm_group_label>Hydrotherapy Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Maternal Age &gt;18 years&#xD;
&#xD;
          -  Oligohydramnios: diagnosed by sonography (defined AFV&lt;8cm)&#xD;
&#xD;
          -  Singleton Pregnancy&#xD;
&#xD;
          -  Intact membranes&#xD;
&#xD;
          -  Gestational age 24 - 36 weeks&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Indication for urgent delivery (severe PET, HELLP syndrome, persistent fetal hypoxemia&#xD;
             [non-reassuring fetal heart rate pattern])&#xD;
&#xD;
          -  Ruptured amniotic membranes; PPROM, PROM, SROM&#xD;
&#xD;
          -  Fever (&gt;38C)&#xD;
&#xD;
          -  Multiple gestation&#xD;
&#xD;
          -  &gt;37 week gestation&#xD;
&#xD;
          -  Lethal Fetal anomalies and/or demise&#xD;
&#xD;
          -  Maternal Cardiovascular disease&#xD;
&#xD;
          -  Maternal Renal disease&#xD;
&#xD;
          -  Maternal Pulmonary disease (other than asthma)&#xD;
&#xD;
          -  Patients using prostaglandin inhibitors, NSAIDs3,15 (within 1 week of enrollment,&#xD;
             other than baby asprin)&#xD;
&#xD;
          -  Non-English speaking&#xD;
&#xD;
          -  Vaginal Infections and/or active skin lesions&#xD;
&#xD;
          -  Placenta Previa and/or Unexplained Vaginal Bleeding&#xD;
&#xD;
          -  BMI &gt; 45&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Thomas H Strong, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Obstetrix Medical Group</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Banner Good Samaritan Medical Center</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85212</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2020</verification_date>
  <study_first_submitted>September 6, 2012</study_first_submitted>
  <study_first_submitted_qc>September 7, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 11, 2012</study_first_posted>
  <results_first_submitted>August 28, 2019</results_first_submitted>
  <results_first_submitted_qc>March 27, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">March 30, 2020</results_first_posted>
  <last_update_submitted>March 27, 2020</last_update_submitted>
  <last_update_submitted_qc>March 27, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 30, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Oligohydramnios</keyword>
  <keyword>Hydrotherapy</keyword>
  <keyword>Pregnancy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Oligohydramnios</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Recruitment began April 8, 2012 and ended April 2014. Recruitment took place at Banner Good Samaritan hospital based on Banner IRB approval.</recruitment_details>
      <pre_assignment_details>There were no pre-assignment events.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>IV/Oral Hydration and Bedrest</title>
          <description>1 Liter Water PO over 2 hours&#xD;
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&#xD;
AC/EFW&#xD;
Umbilical Artery Doppler Flow (Baseline, day 3, 7 {or Discharge})&#xD;
Uterine Artery Doppler Flow (Baseline, day 3, 7 {or Discharge})&#xD;
AFI (Baseline, day 3, 7 {or Discharge})</description>
        </group>
        <group group_id="P2">
          <title>Hydrotherapy Group</title>
          <description>US Procedures&#xD;
AC/EFW&#xD;
Umbilical Artery Doppler Flow (Baseline,&#xD;
Uterine Artery Doppler Flow (Baseline,&#xD;
AFI (Baseline,&#xD;
Strict I/O's&#xD;
Vital signs&#xD;
HYDROTHERAPY TWICE DAILY FOR 3-7 DAYS&#xD;
o Blood pressure, pulse, pulse pressure, body weight, and fetal heart rate before and after submersion therapy Hydrotherapy: • Maternal BP (sitting)&#xD;
Pulse Pressure&#xD;
Pulse&#xD;
Urine Specific Gravity BID&#xD;
Fetal Heart Rate&#xD;
Maternal Body Weight US Procedures&#xD;
AC/EFW&#xD;
Umbilical Artery Doppler Flow&#xD;
Uterine Artery Doppler Flow • AFI (Baseline, day 3, 7 {or Discharge})</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="2">2 subjects in this Arm</participants>
                <participants group_id="P2" count="2">2 subjects in this Arm</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>IV/Oral Hydration and Bedrest</title>
          <description>IV/Oral Hydration and Bedrest:&#xD;
Maternal BP (sitting)&#xD;
Pulse Pressure&#xD;
Pulse&#xD;
Urine Specific Gravity BID&#xD;
Fetal Heart Rate&#xD;
Maternal Body Weight US Procedures&#xD;
AC/EFW&#xD;
Umbilical Artery Doppler Flow (Baseline, day 3, 7 {or Discharge})&#xD;
Uterine Artery Doppler Flow (Baseline, day 3, 7 {or Discharge})&#xD;
AFI (Baseline, day 3, 7 {or Discharge})&#xD;
ALL ITEMS ABOVE MUST BE COMPLETED BEFORE:&#xD;
1 Liter Water PO over 2 hours&#xD;
1 Liter IV Fluid Bolus (NS) then titrated to 75 ml\hr for duration of the study participation&#xD;
Strict I/O's&#xD;
Vital signs</description>
        </group>
        <group group_id="B2">
          <title>Hydrotherapy Group</title>
          <description>• HYDROTHERAPY TWICE DAILY FOR 3-7 DAYS&#xD;
o Blood pressure, pulse, pulse pressure, body weight, and fetal heart rate before and after submersion therapy&#xD;
Hydrotherapy:&#xD;
Maternal BP (sitting)&#xD;
Pulse Pressure&#xD;
Pulse&#xD;
Urine Specific Gravity BID&#xD;
Fetal Heart Rate&#xD;
Maternal Body Weight US Procedures&#xD;
AC/EFW&#xD;
Umbilical Artery Doppler Flow (Baseline, day 3, 7 {or Discharge})&#xD;
o 1 hour +/- 30 minutes after submersion therapy&#xD;
AFI (Baseline, day 3, 7 {or Discharge}) o 1 hour +/- 30 minutes after submersion therapy&#xD;
ALL ITEMS ABOVE MUST BE COMPLETED BEFORE:&#xD;
1 Liter Water PO over 2 hours&#xD;
1 Liter IV Fluid Bolus (NS) then titrated to 75 ml\hr for duration of the study participation&#xD;
Strict I/O's&#xD;
Vital signs</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="2"/>
            <count group_id="B2" value="2"/>
            <count group_id="B3" value="4"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="31.5" lower_limit="29" upper_limit="34"/>
                    <measurement group_id="B2" value="23" lower_limit="21" upper_limit="25"/>
                    <measurement group_id="B3" value="27.25" lower_limit="21" upper_limit="34"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>1. Primary: Number of Participants With Reversal of Oligohydramnios Using AFV Measures</title>
        <description>Subjects amniotic fluid index via ultrasound on days 3, 5 and 7 of study participation.</description>
        <time_frame>days 3, and 7 or discharge</time_frame>
        <population>no formal analysis done on the 4 enrolled patients, study halted due to poor enrollment. Data cannot be reported due to participant privacy.</population>
        <group_list>
          <group group_id="O1">
            <title>IV/Oral Hydration and Bedrest</title>
            <description>IV/Oral Hydration and Bedrest for up to 7 days&#xD;
US Procedures&#xD;
AC/EFW&#xD;
Umbilical Artery Doppler Flow (Baseline, day 3, 7 {or Discharge})&#xD;
Uterine Artery Doppler Flow (Baseline, day 3, 7 {or Discharge})&#xD;
AFI (Baseline, day 3, 7 {or Discharge})&#xD;
ALL ITEMS ABOVE MUST BE COMPLETED BEFORE:&#xD;
1 Liter Water PO over 2 hours&#xD;
1 Liter IV Fluid Bolus (NS) then titrated to 75 ml\hr for duration of the study participation&#xD;
Strict I/O's&#xD;
Vital signs&#xD;
: • Maternal BP (sitting)&#xD;
Pulse Pressure&#xD;
Pulse&#xD;
Urine Specific Gravity BID&#xD;
Fetal Heart Rate&#xD;
Maternal Body Weight US Procedures&#xD;
AC/EFW&#xD;
Umbilical Artery Doppler Flow (Baseline, day 3, 7 {or Discharge})&#xD;
Uterine Artery Doppler Flow (Baseline, day 3, 7 {or Discharge})&#xD;
AFI (Baseline, day 3, 7 {or Discharge})&#xD;
ALL ITEMS ABOVE MUST BE COMPLETED BEFORE:&#xD;
1 Liter Water PO over 2 hours&#xD;
1 Liter IV</description>
          </group>
          <group group_id="O2">
            <title>Hydrotherapy Group</title>
            <description>HYDROTHERAPY TWICE DAILY FOR 3-7 DAYS&#xD;
Maternal BP (sitting) US Procedures&#xD;
AC/EFW&#xD;
Umbilical Artery Doppler Flow (Baseline, day 3, 7 {or Discharge})&#xD;
o 1 hour +/- 30 minutes after submersion therapy&#xD;
Uterine Artery Doppler Flow (Baseline, day 3, 7 {or Discharge})&#xD;
o 1 hour +/- 30 minutes after submersion therapy&#xD;
AFI (Baseline, day 3, 7 {or Discharge}) o 1 hour +/- 30 minutes after submersion therapy&#xD;
ALL ITEMS ABOVE MUST BE COMPLETED BEFORE:&#xD;
1 Liter Water PO over 2 hours&#xD;
1 Liter IV Fluid Bolus (NS) then titrated to 75 ml\hr for duration of the study participation&#xD;
Strict I/O's&#xD;
Vital signs&#xD;
Blood pressure, pulse, pulse pressure, body weight, and fetal heart rate before and after submersion therapy&#xD;
Hydrotherapy: • Maternal BP (sitting)&#xD;
Pulse Pressure&#xD;
Pulse&#xD;
Urine Specific Gravity BID&#xD;
Fetal Heart Rate&#xD;
Maternal Body Weight</description>
          </group>
        </group_list>
        <measure>
          <title>1. Primary: Number of Participants With Reversal of Oligohydramnios Using AFV Measures</title>
          <description>Subjects amniotic fluid index via ultrasound on days 3, 5 and 7 of study participation.</description>
          <population>no formal analysis done on the 4 enrolled patients, study halted due to poor enrollment. Data cannot be reported due to participant privacy.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Metabolic Status</title>
        <description>Secondary:&#xD;
- Changes in maternal hemodynamic status by mobilizing extravascular fluid</description>
        <time_frame>admission, days 3, 5, 7/discharge and delivery</time_frame>
        <population>No analysis done as study halted for poor enrollment only 4 subjects enrolled total. Detailed Data cannot be reported due to participant privacy.</population>
        <group_list>
          <group group_id="O1">
            <title>IV/Oral Hydration and Bedrest</title>
            <description>IV/Oral Hydration and Bedrest up to 7 days&#xD;
AC/EFW&#xD;
Umbilical Artery Doppler Flow (Baseline, day 3, 7 {or Discharge})&#xD;
Uterine Artery Doppler Flow (Baseline, day 3, 7 {or Discharge})&#xD;
AFI (Baseline, day 3, 7 {or Discharge})&#xD;
ALL ITEMS ABOVE MUST BE COMPLETED BEFORE:&#xD;
1 Liter Water PO over 2 hours&#xD;
1 Liter IV Fluid Bolus (NS) then titrated to 75 ml\hr for duration of the study participation&#xD;
Strict I/O's&#xD;
Vital signs&#xD;
: • Maternal BP (sitting)&#xD;
Pulse Pressure&#xD;
Pulse&#xD;
Urine Specific Gravity BID&#xD;
Fetal Heart Rate&#xD;
Maternal Body Weight US Procedures&#xD;
AC/EFW&#xD;
Umbilical Artery Doppler Flow (Baseline, day 3, 7 {or Discharge})&#xD;
Uterine Artery Doppler Flow (Baseline, day 3, 7 {or Discharge})&#xD;
AFI (Baseline, day 3, 7 {or Discharge})&#xD;
ALL ITEMS ABOVE MUST BE COMPLETED BEFORE:&#xD;
1 Liter Water PO over 2 hours&#xD;
1 Liter IV Fluid Bolus (NS) then titrated to 75 ml\hr for duration of the study participation&#xD;
Strict I/O's&#xD;
Vital sign</description>
          </group>
          <group group_id="O2">
            <title>Hydrotherapy Group</title>
            <description>• HYDROTHERAPY TWICE DAILY FOR 3-7 DAYS&#xD;
ALL ITEMS ABOVE MUST BE COMPLETED BEFORE:&#xD;
1 Liter Water PO over 2 hours&#xD;
1 Liter IV Fluid Bolus (NS) then titrated to 75 ml\hr for duration of the study participation&#xD;
Strict I/O's&#xD;
Vital signs&#xD;
Blood pressure, pulse, pulse pressure, body weight, and fetal heart rate before and after submersion therapy&#xD;
Hydrotherapy: • Maternal BP (sitting)&#xD;
Pulse Pressure&#xD;
Pulse&#xD;
Urine Specific Gravity BID&#xD;
Fetal Heart Rate&#xD;
Maternal Body Weight US Procedures&#xD;
AC/EFW&#xD;
Umbilical Artery Doppler Flow (Baseline, day 3, 7 {or Discharge}) o 1 hour +/- 30 minutes after submer</description>
          </group>
        </group_list>
        <measure>
          <title>Metabolic Status</title>
          <description>Secondary:&#xD;
- Changes in maternal hemodynamic status by mobilizing extravascular fluid</description>
          <population>No analysis done as study halted for poor enrollment only 4 subjects enrolled total. Detailed Data cannot be reported due to participant privacy.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>2 years and 4 months</time_frame>
      <group_list>
        <group group_id="E1">
          <title>IV/Oral Hydration and Bedrest</title>
          <description>Maternal BP (sitting)&#xD;
Pulse Pressure&#xD;
Pulse&#xD;
Urine Specific Gravity BID&#xD;
Fetal Heart Rate&#xD;
Maternal Body Weight US Procedures&#xD;
AC/EFW&#xD;
Umbilical Artery Doppler Flow (Baseline, day 3, 7 {or Discharge})&#xD;
Uterine Artery Doppler Flow (Baseline, day 3, 7 {or Discharge})&#xD;
AFI (Baseline, day 3, 7 {or Discharge})&#xD;
ALL ITEMS ABOVE MUST BE COMPLETED BEFORE:&#xD;
1 Liter Water PO over 2 hours&#xD;
1 Liter IV Fluid Bolus (NS) then titrated to 75 ml\hr for duration of the study participation&#xD;
Strict I/O's&#xD;
Vital signs&#xD;
IV/Oral Hydration and Bedrest: • Maternal BP (sitting)&#xD;
Pulse Pressure&#xD;
Pulse&#xD;
Urine Specific Gravity BID&#xD;
Fetal Heart Rate&#xD;
Maternal Body Weight US Procedures&#xD;
AC/EFW&#xD;
Umbilical Artery Doppler Flow (Baseline, day 3, 7 {or Discharge})&#xD;
Uterine Artery Doppler Flow (Baseline, day 3, 7 {or Discharge})&#xD;
AFI (Baseline, day 3, 7 {or Discharge})</description>
        </group>
        <group group_id="E2">
          <title>Hydrotherapy Group</title>
          <description>Maternal BP (sitting)&#xD;
Pulse Pressure&#xD;
Pulse&#xD;
Urine Specific Gravity BID&#xD;
Fetal Heart Rate&#xD;
Maternal Body Weight US Procedures&#xD;
AC/EFW&#xD;
Umbilical Artery Doppler Flow (Baseline, day 3, 7 {or Discharge})&#xD;
o 1 hour +/- 30 minutes after submersion therapy&#xD;
Uterine Artery Doppler Flow (Baseline, day 3, 7 {or Discharge})&#xD;
o 1 hour +/- 30 minutes after submersion therapy&#xD;
AFI (Baseline, day 3, 7 {or Discharge}) o 1 hour +/- 30 minutes after submersion therapy&#xD;
ALL ITEMS ABOVE MUST BE COMPLETED BEFORE:&#xD;
1 Liter Water PO over 2 hours&#xD;
1 Liter IV Fluid Bolus (NS) then titrated to 75 ml\hr for duration of the study participation&#xD;
Strict I/O's&#xD;
Vital signs&#xD;
HYDROTHERAPY TWICE DAILY FOR 3-7 DAYS o Blood pressure, pulse, pulse pressure, body weight, and fetal heart rate before and after submersion therapy</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="2"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="2"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Ana Braescu</name_or_title>
      <organization>Mednax</organization>
      <phone>480-969-5999</phone>
      <email>ana_braescu@mednax.com</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01682928
org study id: STRONG-2012
nct id: NCT01682928
lead sponsor: 
collaborator: 
has dmc: No
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
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: 1. Primary: Number of Participants With Reversal of Oligohydramnios Using AFV Measures
time frame: days 3, and 7 or discharge
description: Subjects amniotic fluid index via ultrasound on days 3, 5 and 7 of study participation.
measure: Metabolic Status
time frame: admission, days 3, 5, 7/discharge and delivery
description: Secondary:
- Changes in maternal hemodynamic status by mobilizing extravascular fluid
arm group label: IV/Oral Hydration and Bedrest
arm group type: Active Comparator
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 group label: Hydrotherapy Group
arm group type: Active Comparator
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: IV/Oral Hydration and Bedrest
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 group label: IV/Oral Hydration and Bedrest
intervention type: Other
intervention name: Hydrotherapy
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
arm group label: Hydrotherapy Group
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Thomas H Strong, MD
role: Principal Investigator
affiliation: Obstetrix Medical Group
facility: 
country: United States
responsible party type: Sponsor
mesh term: Oligohydramnios
sharing ipd: No
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 