Ignite Creation Date:
2025-12-26 @ 10:36 AM
Ignite Modification Date:
2026-03-06 @ 1:33 AM
Study NCT ID:
NCT01682928
Status:
TERMINATED
Last Update Posted:
2020-03-30
First Post:
2012-09-06
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Hydrotherapy for the Reversal of Oligohydramnios
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016104', 'term': 'Oligohydramnios'}], 'ancestors': [{'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001510', 'term': 'Bed Rest'}, {'id': 'D006875', 'term': 'Hydrotherapy'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D012046', 'term': 'Rehabilitation'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ana_braescu@mednax.com', 'phone': '480-969-5999', 'title': 'Ana Braescu', 'organization': 'Mednax'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '2 years and 4 months', 'eventGroups': [{'id': 'EG000', 'title': 'IV/Oral Hydration and Bedrest', 'description': "* Maternal BP (sitting)\n* Pulse Pressure\n* Pulse\n* Urine Specific Gravity BID\n* Fetal Heart Rate\n* Maternal Body Weight US Procedures\n* AC/EFW\n* Umbilical Artery Doppler Flow (Baseline, day 3, 7 {or Discharge})\n* Uterine Artery Doppler Flow (Baseline, day 3, 7 {or Discharge})\n* AFI (Baseline, day 3, 7 {or Discharge})\n\nALL ITEMS ABOVE MUST BE COMPLETED BEFORE:\n\n* 1 Liter Water PO over 2 hours\n* 1 Liter IV Fluid Bolus (NS) then titrated to 75 ml\\\\hr for duration of the study participation\n* Strict I/O's\n* Vital signs\n\nIV/Oral Hydration and Bedrest: • Maternal BP (sitting)\n\n* Pulse Pressure\n* Pulse\n* Urine Specific Gravity BID\n* Fetal Heart Rate\n* Maternal Body Weight US Procedures\n* AC/EFW\n* Umbilical Artery Doppler Flow (Baseline, day 3, 7 {or Discharge})\n* Uterine Artery Doppler Flow (Baseline, day 3, 7 {or Discharge})\n* AFI (Baseline, day 3, 7 {or Discharge})", 'otherNumAtRisk': 2, 'otherNumAffected': 0, 'seriousNumAtRisk': 2, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Hydrotherapy Group', 'description': "* Maternal BP (sitting)\n* Pulse Pressure\n* Pulse\n* Urine Specific Gravity BID\n* Fetal Heart Rate\n* Maternal Body Weight US Procedures\n* AC/EFW\n* Umbilical Artery Doppler Flow (Baseline, day 3, 7 {or Discharge})\n\n o 1 hour +/- 30 minutes after submersion therapy\n* Uterine Artery Doppler Flow (Baseline, day 3, 7 {or Discharge})\n\n o 1 hour +/- 30 minutes after submersion therapy\n* AFI (Baseline, day 3, 7 {or Discharge}) o 1 hour +/- 30 minutes after submersion therapy\n\nALL ITEMS ABOVE MUST BE COMPLETED BEFORE:\n\n* 1 Liter Water PO over 2 hours\n* 1 Liter IV Fluid Bolus (NS) then titrated to 75 ml\\\\hr for duration of the study participation\n* Strict I/O's\n* Vital signs\n* HYDROTHERAPY TWICE DAILY FOR 3-7 DAYS o Blood pressure, pulse, pulse pressure, body weight, and fetal heart rate before and after submersion therapy", 'otherNumAtRisk': 2, 'otherNumAffected': 0, 'seriousNumAtRisk': 2, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': '1. Primary: Number of Participants With Reversal of Oligohydramnios Using AFV Measures', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IV/Oral Hydration and Bedrest', 'description': "IV/Oral Hydration and Bedrest for up to 7 days\n\nUS Procedures\n\n* AC/EFW\n* Umbilical Artery Doppler Flow (Baseline, day 3, 7 {or Discharge})\n* Uterine Artery Doppler Flow (Baseline, day 3, 7 {or Discharge})\n* AFI (Baseline, day 3, 7 {or Discharge})\n\nALL ITEMS ABOVE MUST BE COMPLETED BEFORE:\n\n* 1 Liter Water PO over 2 hours\n* 1 Liter IV Fluid Bolus (NS) then titrated to 75 ml\\\\hr for duration of the study participation\n* Strict I/O's\n* Vital signs\n\n : • Maternal BP (sitting)\n* Pulse Pressure\n* Pulse\n* Urine Specific Gravity BID\n* Fetal Heart Rate\n* Maternal Body Weight US Procedures\n* AC/EFW\n* Umbilical Artery Doppler Flow (Baseline, day 3, 7 {or Discharge})\n* Uterine Artery Doppler Flow (Baseline, day 3, 7 {or Discharge})\n* AFI (Baseline, day 3, 7 {or Discharge})\n\nALL ITEMS ABOVE MUST BE COMPLETED BEFORE:\n\n* 1 Liter Water PO over 2 hours\n* 1 Liter IV"}, {'id': 'OG001', 'title': 'Hydrotherapy Group', 'description': "HYDROTHERAPY TWICE DAILY FOR 3-7 DAYS\n\n* Maternal BP (sitting) US Procedures\n* AC/EFW\n* Umbilical Artery Doppler Flow (Baseline, day 3, 7 {or Discharge})\n\n o 1 hour +/- 30 minutes after submersion therapy\n* Uterine Artery Doppler Flow (Baseline, day 3, 7 {or Discharge})\n\n o 1 hour +/- 30 minutes after submersion therapy\n* AFI (Baseline, day 3, 7 {or Discharge}) o 1 hour +/- 30 minutes after submersion therapy\n\nALL ITEMS ABOVE MUST BE COMPLETED BEFORE:\n\n* 1 Liter Water PO over 2 hours\n* 1 Liter IV Fluid Bolus (NS) then titrated to 75 ml\\\\hr for duration of the study participation\n* Strict I/O's\n* Vital signs\n\n * Blood pressure, pulse, pulse pressure, body weight, and fetal heart rate before and after submersion therapy\n\nHydrotherapy: • Maternal BP (sitting)\n\n* Pulse Pressure\n* Pulse\n* Urine Specific Gravity BID\n* Fetal Heart Rate\n* Maternal Body Weight"}], 'timeFrame': 'days 3, and 7 or discharge', 'description': 'Subjects amniotic fluid index via ultrasound on days 3, 5 and 7 of study participation.', 'reportingStatus': 'POSTED', 'populationDescription': 'no formal analysis done on the 4 enrolled patients, study halted due to poor enrollment. Data cannot be reported due to participant privacy.'}, {'type': 'SECONDARY', 'title': 'Metabolic Status', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IV/Oral Hydration and Bedrest', 'description': "IV/Oral Hydration and Bedrest up to 7 days\n\n* AC/EFW\n* Umbilical Artery Doppler Flow (Baseline, day 3, 7 {or Discharge})\n* Uterine Artery Doppler Flow (Baseline, day 3, 7 {or Discharge})\n* AFI (Baseline, day 3, 7 {or Discharge})\n\nALL ITEMS ABOVE MUST BE COMPLETED BEFORE:\n\n* 1 Liter Water PO over 2 hours\n* 1 Liter IV Fluid Bolus (NS) then titrated to 75 ml\\\\hr for duration of the study participation\n* Strict I/O's\n* Vital signs\n\n : • Maternal BP (sitting)\n* Pulse Pressure\n* Pulse\n* Urine Specific Gravity BID\n* Fetal Heart Rate\n* Maternal Body Weight US Procedures\n* AC/EFW\n* Umbilical Artery Doppler Flow (Baseline, day 3, 7 {or Discharge})\n* Uterine Artery Doppler Flow (Baseline, day 3, 7 {or Discharge})\n* AFI (Baseline, day 3, 7 {or Discharge})\n\nALL ITEMS ABOVE MUST BE COMPLETED BEFORE:\n\n* 1 Liter Water PO over 2 hours\n* 1 Liter IV Fluid Bolus (NS) then titrated to 75 ml\\\\hr for duration of the study participation\n* Strict I/O's\n* Vital sign"}, {'id': 'OG001', 'title': 'Hydrotherapy Group', 'description': "• HYDROTHERAPY TWICE DAILY FOR 3-7 DAYS\n\nALL ITEMS ABOVE MUST BE COMPLETED BEFORE:\n\n* 1 Liter Water PO over 2 hours\n* 1 Liter IV Fluid Bolus (NS) then titrated to 75 ml\\\\hr for duration of the study participation\n* Strict I/O's\n* Vital signs\n\n * Blood pressure, pulse, pulse pressure, body weight, and fetal heart rate before and after submersion therapy\n\nHydrotherapy: • Maternal BP (sitting)\n\n* Pulse Pressure\n* Pulse\n* Urine Specific Gravity BID\n* Fetal Heart Rate\n* Maternal Body Weight US Procedures\n* AC/EFW\n* Umbilical Artery Doppler Flow (Baseline, day 3, 7 {or Discharge}) o 1 hour +/- 30 minutes after submer"}], 'timeFrame': 'admission, days 3, 5, 7/discharge and delivery', 'description': 'Secondary:\n\n\\- Changes in maternal hemodynamic status by mobilizing extravascular fluid', 'reportingStatus': 'POSTED', 'populationDescription': 'No analysis done as study halted for poor enrollment only 4 subjects enrolled total. Detailed Data cannot be reported due to participant privacy.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'IV/Oral Hydration and Bedrest', 'description': "1 Liter Water PO over 2 hours\n\n1 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\n\n* AC/EFW\n* Umbilical Artery Doppler Flow (Baseline, day 3, 7 {or Discharge})\n* Uterine Artery Doppler Flow (Baseline, day 3, 7 {or Discharge})\n* AFI (Baseline, day 3, 7 {or Discharge})"}, {'id': 'FG001', 'title': 'Hydrotherapy Group', 'description': "US Procedures\n\n* AC/EFW\n* Umbilical Artery Doppler Flow (Baseline,\n* Uterine Artery Doppler Flow (Baseline,\n* AFI (Baseline,\n* Strict I/O's\n* Vital signs\n* HYDROTHERAPY TWICE DAILY FOR 3-7 DAYS\n\n o Blood pressure, pulse, pulse pressure, body weight, and fetal heart rate before and after submersion therapy Hydrotherapy: • Maternal BP (sitting)\n* Pulse Pressure\n* Pulse\n* Urine Specific Gravity BID\n* Fetal Heart Rate\n* Maternal Body Weight US Procedures\n* AC/EFW\n* Umbilical Artery Doppler Flow\n* Uterine Artery Doppler Flow • AFI (Baseline, day 3, 7 {or Discharge})"}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': '2 subjects in this Arm', 'groupId': 'FG000', 'numSubjects': '2'}, {'comment': '2 subjects in this Arm', 'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Recruitment began April 8, 2012 and ended April 2014. Recruitment took place at Banner Good Samaritan hospital based on Banner IRB approval.', 'preAssignmentDetails': 'There were no pre-assignment events.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'IV/Oral Hydration and Bedrest', 'description': "IV/Oral Hydration and Bedrest:\n\n* Maternal BP (sitting)\n* Pulse Pressure\n* Pulse\n* Urine Specific Gravity BID\n* Fetal Heart Rate\n* Maternal Body Weight US Procedures\n* AC/EFW\n* Umbilical Artery Doppler Flow (Baseline, day 3, 7 {or Discharge})\n* Uterine Artery Doppler Flow (Baseline, day 3, 7 {or Discharge})\n* AFI (Baseline, day 3, 7 {or Discharge})\n\nALL ITEMS ABOVE MUST BE COMPLETED BEFORE:\n\n* 1 Liter Water PO over 2 hours\n* 1 Liter IV Fluid Bolus (NS) then titrated to 75 ml\\\\hr for duration of the study participation\n* Strict I/O's\n* Vital signs"}, {'id': 'BG001', 'title': 'Hydrotherapy Group', 'description': "• HYDROTHERAPY TWICE DAILY FOR 3-7 DAYS\n\no Blood pressure, pulse, pulse pressure, body weight, and fetal heart rate before and after submersion therapy\n\nHydrotherapy:\n\n* Maternal BP (sitting)\n* Pulse Pressure\n* Pulse\n* Urine Specific Gravity BID\n* Fetal Heart Rate\n* Maternal Body Weight US Procedures\n* AC/EFW\n* Umbilical Artery Doppler Flow (Baseline, day 3, 7 {or Discharge})\n\n o 1 hour +/- 30 minutes after submersion therapy\n* AFI (Baseline, day 3, 7 {or Discharge}) o 1 hour +/- 30 minutes after submersion therapy\n\nALL ITEMS ABOVE MUST BE COMPLETED BEFORE:\n\n* 1 Liter Water PO over 2 hours\n* 1 Liter IV Fluid Bolus (NS) then titrated to 75 ml\\\\hr for duration of the study participation\n* Strict I/O's\n* Vital signs"}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '31.5', 'groupId': 'BG000', 'lowerLimit': '29', 'upperLimit': '34'}, {'value': '23', 'groupId': 'BG001', 'lowerLimit': '21', 'upperLimit': '25'}, {'value': '27.25', 'groupId': 'BG002', 'lowerLimit': '21', 'upperLimit': '34'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 4}}, 'statusModule': {'whyStopped': 'Poor enrollment', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2012-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-03-27', 'studyFirstSubmitDate': '2012-09-06', 'resultsFirstSubmitDate': '2019-08-28', 'studyFirstSubmitQcDate': '2012-09-07', 'lastUpdatePostDateStruct': {'date': '2020-03-30', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-03-27', 'studyFirstPostDateStruct': {'date': '2012-09-11', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-03-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '1. Primary: Number of Participants With Reversal of Oligohydramnios Using AFV Measures', 'timeFrame': 'days 3, and 7 or discharge', 'description': 'Subjects amniotic fluid index via ultrasound on days 3, 5 and 7 of study participation.'}], 'secondaryOutcomes': [{'measure': 'Metabolic Status', 'timeFrame': 'admission, days 3, 5, 7/discharge and delivery', 'description': 'Secondary:\n\n\\- Changes in maternal hemodynamic status by mobilizing extravascular fluid'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Oligohydramnios', 'Hydrotherapy', 'Pregnancy'], 'conditions': ['Oligohydramnios']}, 'descriptionModule': {'briefSummary': '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.\n\nHYPOTHESIS: Oligohydramnios, secondary to depleted maternal intravascular volume, can be reversed by improving feto- and uteroplacental perfusion with subtotal immersion therapy.', 'detailedDescription': '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\n\nIn 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.\n\nThe 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'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Maternal Age \\>18 years\n* Oligohydramnios: diagnosed by sonography (defined AFV\\<8cm)\n* Singleton Pregnancy\n* Intact membranes\n* Gestational age 24 - 36 weeks\n\nExclusion Criteria:\n\n* Indication for urgent delivery (severe PET, HELLP syndrome, persistent fetal hypoxemia \\[non-reassuring fetal heart rate pattern\\])\n* Ruptured amniotic membranes; PPROM, PROM, SROM\n* Fever (\\>38C)\n* Multiple gestation\n* \\>37 week gestation\n* Lethal Fetal anomalies and/or demise\n* Maternal Cardiovascular disease\n* Maternal Renal disease\n* Maternal Pulmonary disease (other than asthma)\n* Patients using prostaglandin inhibitors, NSAIDs3,15 (within 1 week of enrollment, other than baby asprin)\n* Non-English speaking\n* Vaginal Infections and/or active skin lesions\n* Placenta Previa and/or Unexplained Vaginal Bleeding\n* BMI \\> 45'}, 'identificationModule': {'nctId': 'NCT01682928', 'acronym': 'STRONG', 'briefTitle': 'Hydrotherapy for the Reversal of Oligohydramnios', 'organization': {'class': 'OTHER', 'fullName': 'Pediatrix'}, 'officialTitle': 'Submersion Therapy for the Reversal of Oligohydramnios; A Non-invasive Gentle Approach', 'orgStudyIdInfo': {'id': 'STRONG-2012'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'IV/Oral Hydration and Bedrest', 'description': "* Maternal BP (sitting)\n* Pulse Pressure\n* Pulse\n* Urine Specific Gravity BID\n* Fetal Heart Rate\n* Maternal Body Weight US Procedures\n* AC/EFW\n* Umbilical Artery Doppler Flow (Baseline, day 3, 7 {or Discharge})\n* Uterine Artery Doppler Flow (Baseline, day 3, 7 {or Discharge})\n* AFI (Baseline, day 3, 7 {or Discharge})\n\nALL ITEMS ABOVE MUST BE COMPLETED BEFORE:\n\n* 1 Liter Water PO over 2 hours\n* 1 Liter IV Fluid Bolus (NS) then titrated to 75 ml\\\\hr for duration of the study participation\n* Strict I/O's\n* Vital signs", 'interventionNames': ['Drug: IV/Oral Hydration and Bedrest']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Hydrotherapy Group', 'description': "* Maternal BP (sitting)\n* Pulse Pressure\n* Pulse\n* Urine Specific Gravity BID\n* Fetal Heart Rate\n* Maternal Body Weight US Procedures\n* AC/EFW\n* Umbilical Artery Doppler Flow (Baseline, day 3, 7 {or Discharge})\n\n o 1 hour +/- 30 minutes after submersion therapy\n* Uterine Artery Doppler Flow (Baseline, day 3, 7 {or Discharge})\n\n o 1 hour +/- 30 minutes after submersion therapy\n* AFI (Baseline, day 3, 7 {or Discharge}) o 1 hour +/- 30 minutes after submersion therapy\n\nALL ITEMS ABOVE MUST BE COMPLETED BEFORE:\n\n* 1 Liter Water PO over 2 hours\n* 1 Liter IV Fluid Bolus (NS) then titrated to 75 ml\\\\hr for duration of the study participation\n* Strict I/O's\n* Vital signs\n* HYDROTHERAPY TWICE DAILY FOR 3-7 DAYS o Blood pressure, pulse, pulse pressure, body weight, and fetal heart rate before and after submersion therapy", 'interventionNames': ['Other: Hydrotherapy']}], 'interventions': [{'name': 'IV/Oral Hydration and Bedrest', 'type': 'DRUG', 'description': "* Maternal BP (sitting)\n* Pulse Pressure\n* Pulse\n* Urine Specific Gravity BID\n* Fetal Heart Rate\n* Maternal Body Weight US Procedures\n* AC/EFW\n* Umbilical Artery Doppler Flow (Baseline, day 3, 7 {or Discharge})\n* Uterine Artery Doppler Flow (Baseline, day 3, 7 {or Discharge})\n* AFI (Baseline, day 3, 7 {or Discharge})\n\nALL ITEMS ABOVE MUST BE COMPLETED BEFORE:\n\n* 1 Liter Water PO over 2 hours\n* 1 Liter IV Fluid Bolus (NS) then titrated to 75 ml\\\\hr for duration of the study participation\n* Strict I/O's\n* Vital signs", 'armGroupLabels': ['IV/Oral Hydration and Bedrest']}, {'name': 'Hydrotherapy', 'type': 'OTHER', 'description': "* Maternal BP (sitting)\n* Pulse Pressure\n* Pulse\n* Urine Specific Gravity BID\n* Fetal Heart Rate\n* Maternal Body Weight US Procedures\n* AC/EFW\n* Umbilical Artery Doppler Flow (Baseline, day 3, 7 {or Discharge})\n\n o 1 hour +/- 30 minutes after submersion therapy\n* Uterine Artery Doppler Flow (Baseline, day 3, 7 {or Discharge})\n\n o 1 hour +/- 30 minutes after submersion therapy\n* AFI (Baseline, day 3, 7 {or Discharge}) o 1 hour +/- 30 minutes after submersion therapy\n\nALL ITEMS ABOVE MUST BE COMPLETED BEFORE:\n\n* 1 Liter Water PO over 2 hours\n* 1 Liter IV Fluid Bolus (NS) then titrated to 75 ml\\\\hr for duration of the study participation\n* Strict I/O's\n* Vital signs\n* HYDROTHERAPY TWICE DAILY FOR 3-7 DAYS o Blood pressure, pulse, pulse pressure, body weight, and fetal heart rate before and after submersion therapy", 'armGroupLabels': ['Hydrotherapy Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85212', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Banner Good Samaritan Medical Center', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}], 'overallOfficials': [{'name': 'Thomas H Strong, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Obstetrix Medical Group'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pediatrix', 'class': 'OTHER'}, 'collaborators': [{'name': 'Banner Health', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}