Trial Outcomes & Findings for Hydrotherapy for the Reversal of Oligohydramnios (NCT NCT01682928)
NCT ID: NCT01682928
Last Updated: 2020-03-30
Results Overview
Subjects amniotic fluid index via ultrasound on days 3, 5 and 7 of study participation.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
4 participants
Primary outcome timeframe
days 3, and 7 or discharge
Results posted on
2020-03-30
Participant Flow
Recruitment began April 8, 2012 and ended April 2014. Recruitment took place at Banner Good Samaritan hospital based on Banner IRB approval.
There were no pre-assignment events.
Participant milestones
| Measure |
IV/Oral Hydration and Bedrest
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 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})
|
Hydrotherapy Group
US Procedures
* AC/EFW
* Umbilical Artery Doppler Flow (Baseline,
* Uterine Artery Doppler Flow (Baseline,
* AFI (Baseline,
* 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 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
* Uterine Artery Doppler Flow • AFI (Baseline, day 3, 7 {or Discharge})
|
|---|---|---|
|
Overall Study
STARTED
|
2
|
2
|
|
Overall Study
COMPLETED
|
2
|
2
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Hydrotherapy for the Reversal of Oligohydramnios
Baseline characteristics by cohort
| Measure |
IV/Oral Hydration and Bedrest
n=2 Participants
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
n=2 Participants
• 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
|
Total
n=4 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
31.5 years
n=5 Participants
|
23 years
n=7 Participants
|
27.25 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: days 3, and 7 or dischargePopulation: no formal analysis done on the 4 enrolled patients, study halted due to poor enrollment. Data cannot be reported due to participant privacy.
Subjects amniotic fluid index via ultrasound on days 3, 5 and 7 of study participation.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: admission, days 3, 5, 7/discharge and deliveryPopulation: No analysis done as study halted for poor enrollment only 4 subjects enrolled total. Detailed Data cannot be reported due to participant privacy.
Secondary: \- Changes in maternal hemodynamic status by mobilizing extravascular fluid
Outcome measures
Outcome data not reported
Adverse Events
IV/Oral Hydration and Bedrest
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Hydrotherapy Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place