NCT01682928

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2012

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2012

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 6, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 11, 2012

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
5.3 years until next milestone

Results Posted

Study results publicly available

March 30, 2020

Completed
Last Updated

March 30, 2020

Status Verified

March 1, 2020

Enrollment Period

2.3 years

First QC Date

September 6, 2012

Results QC Date

August 28, 2019

Last Update Submit

March 27, 2020

Conditions

Oligohydramnios

Keywords

OligohydramniosHydrotherapyPregnancy

Outcome Measures

Primary Outcomes (1)

  • 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.

    days 3, and 7 or discharge

Secondary Outcomes (1)

  • Metabolic Status

    admission, days 3, 5, 7/discharge and delivery

Study Arms (2)

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

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

Other: Hydrotherapy

Interventions

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

IV/Oral Hydration and Bedrest
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}) 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

Hydrotherapy Group

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Banner Good Samaritan Medical Center

Phoenix, Arizona, 85212, United States

Location

MeSH Terms

Conditions

Oligohydramnios

Interventions

Bed RestHydrotherapy

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Intervention Hierarchy (Ancestors)

TherapeuticsPhysical Therapy ModalitiesRehabilitation

Results Point of Contact

Title
Ana Braescu
Organization
Mednax
ana_braescu@mednax.com
480-969-5999

Study Officials

  • Thomas H Strong, MD

    Obstetrix Medical Group

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 6, 2012

First Posted

September 11, 2012

Study Start

August 1, 2012

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

March 30, 2020

Results First Posted

March 30, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)