OligohydramniosSTRONGNCT01682928
Hydrotherapy for the Reversal of Oligohydramnios
A study testing IV/Oral Hydration and Bedrest and Hydrotherapy in people with Oligohydramnios, run by Pediatrix at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Oligohydramnios
- What is being tested?
- IV/Oral Hydration and Bedrest and Hydrotherapy
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2012to Dec 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Maternal Age >18 years
- Oligohydramnios: diagnosed by sonography (defined AFV<8cm)
- Singleton Pregnancy
- Intact membranes
- Gestational age 24 - 36 weeks
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Banner Good Samaritan Medical Center
Phoenix, Arizona, 85212
About this study
Official title: Submersion Therapy for the Reversal of Oligohydramnios; A Non-invasive Gentle Approach
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.
Read the 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
- Conditions
- Oligohydramnios
- Being tested
- IV/Oral Hydration and Bedrest, Hydrotherapy
- Keywords
- Oligohydramnios, Hydrotherapy, Pregnancy
- Medical subject headings
- Oligohydramnios
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IV/Oral Hydration and BedrestDrug
- 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
HydrotherapyOther
- 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})
- 1 hour +/- 30 minutes after submersion therapy
- Uterine Artery Doppler Flow (Baseline, day 3, 7 {or Discharge})
- 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 group | Role | What they receive |
|---|---|---|
| IV/Oral Hydration and Bedrest | 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 Receives: Drug: IV/Oral Hydration and Bedrest |
| Hydrotherapy Group | 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 Receives: Other: Hydrotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: days 3, and 7 or discharge
Secondary outcomes (1)
Metabolic Status
Secondary:
- Changes in maternal hemodynamic status by mobilizing extravascular fluid
Measured: admission, days 3, 5, 7/discharge and delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2012 (estimated)
- Study startAug 2012
- Primary completionDec 2014
- Study completionDec 2014
Why it stopped: Poor enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for OligohydramniosStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pediatrix
- Sponsor type
- University, hospital or other
- Collaborators
- Banner Health
- Responsible party
- Sponsor
- Investigators
- Thomas H Strong, MD, Principal investigator, Obstetrix Medical Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01682928
- Sponsor's protocol ID
- STRONG-2012
- Acronym
- STRONG
- Status last verified
- Mar 2020
- First submitted
- 6 Sep 2012
- Last updated
- 30 Mar 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Submersion Therapy for the Reversal of Oligohydramnios; A Non-invasive Gentle Approach
- ClinicalTrials.gov ID
- NCT01682928
- Acronym / sponsor ID
- STRONG / STRONG-2012
- Conditions
- Oligohydramnios
- Keywords
- Oligohydramnios, Hydrotherapy, Pregnancy
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Poor enrollment
- Enrolment
- 4 participants (actual)
- Lead sponsor
- PediatrixUniversity, hospital or other
- Collaborators
- Banner Health
- Study start
- Aug 2012
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 11 Sep 2012 (estimated)
- Results
- Posted 30 Mar 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IV/Oral Hydration and Bedrest | Active comparator | 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 |
| Hydrotherapy Group | Active comparator | 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Maternal Age >18 years
- Oligohydramnios: diagnosed by sonography (defined AFV<8cm)
- Singleton Pregnancy
- Intact membranes
- Gestational age 24 - 36 weeks
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 |
| 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 | Other | Hydrotherapy Group |
Primary outcome
1. Primary: Number of Participants With Reversal of Oligohydramnios Using AFV Measures
Time frame: days 3, and 7 or discharge
Subjects amniotic fluid index via ultrasound on days 3, 5 and 7 of study participation.
1 secondary outcome
Metabolic Status
Time frame: admission, days 3, 5, 7/discharge and delivery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas H Strong, MD principal investigator
Obstetrix Medical Group
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IV/Oral Hydration and Bedrest and Hydrotherapy in people with Oligohydramnios, run by Pediatrix at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 30 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Mar 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1. Primary: Number of Participants With Reversal of Oligohydramnios Using AFV Measures (time frame: days 3, and 7 or discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2020.