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Hydrotherapy for the Reversal of Oligohydramnios

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

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01682928
Acronym
STRONG
Enrollment
4
Registered
2012-09-11
Start date
2012-08-31
Completion date
2014-12-31
Last updated
2020-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Oligohydramnios

Keywords

Oligohydramnios, Hydrotherapy, Pregnancy

Brief 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. 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

Interventions

DRUGIV/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

OTHERHydrotherapy

* 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

Sponsors

Banner Health
CollaboratorOTHER
Pediatrix
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Maternal Age \>18 years * Oligohydramnios: diagnosed by sonography (defined AFV\<8cm) * Singleton Pregnancy * Intact membranes * Gestational age 24 - 36 weeks

Exclusion criteria

* Indication for urgent delivery (severe PET, HELLP syndrome, persistent fetal hypoxemia \[non-reassuring fetal heart rate pattern\]) * Ruptured amniotic membranes; PPROM, PROM, SROM * Fever (\>38C) * Multiple gestation * \>37 week gestation * Lethal Fetal anomalies and/or demise * Maternal Cardiovascular disease * Maternal Renal disease * Maternal Pulmonary disease (other than asthma) * Patients using prostaglandin inhibitors, NSAIDs3,15 (within 1 week of enrollment, other than baby asprin) * Non-English speaking * Vaginal Infections and/or active skin lesions * Placenta Previa and/or Unexplained Vaginal Bleeding * BMI \> 45

Design outcomes

Primary

MeasureTime frameDescription
1. Primary: Number of Participants With Reversal of Oligohydramnios Using AFV Measuresdays 3, and 7 or dischargeSubjects amniotic fluid index via ultrasound on days 3, 5 and 7 of study participation.

Secondary

MeasureTime frameDescription
Metabolic Statusadmission, days 3, 5, 7/discharge and deliverySecondary: \- Changes in maternal hemodynamic status by mobilizing extravascular fluid

Countries

United States

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.

Pre-assignment details

There were no pre-assignment events.

Participants by arm

ArmCount
IV/Oral Hydration and Bedrest
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
2
Hydrotherapy Group
• HYDROTHERAPY TWICE DAILY FOR 3-7 DAYS o Blood pressure, pulse, pulse pressure, body weight, and fetal heart rate before and after submersion therapy 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 * 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
2
Total4

Baseline characteristics

CharacteristicIV/Oral Hydration and BedrestHydrotherapy GroupTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
2 Participants2 Participants4 Participants
Age, Continuous31.5 years23 years27.25 years
Ethnicity (NIH/OMB)
Hispanic or Latino
1 Participants0 Participants1 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
1 Participants2 Participants3 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants1 Participants1 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
1 Participants0 Participants1 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
1 Participants1 Participants2 Participants
Region of Enrollment
United States
2 Participants2 Participants4 Participants
Sex: Female, Male
Female
2 Participants2 Participants4 Participants
Sex: Female, Male
Male
0 Participants0 Participants0 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
0 / 20 / 2
serious
Total, serious adverse events
0 / 20 / 2

Outcome results

Primary

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.

Time frame: days 3, and 7 or discharge

Population: no formal analysis done on the 4 enrolled patients, study halted due to poor enrollment. Data cannot be reported due to participant privacy.

Secondary

Metabolic Status

Secondary: \- Changes in maternal hemodynamic status by mobilizing extravascular fluid

Time frame: admission, days 3, 5, 7/discharge and delivery

Population: No analysis done as study halted for poor enrollment only 4 subjects enrolled total. Detailed Data cannot be reported due to participant privacy.

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026