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Water Immersion and Changes in the Fetoplacental Circulation

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ClinicalTrials.gov Identifier: NCT01799343
Recruitment Status : Completed
First Posted : February 26, 2013
Last Update Posted : February 26, 2013
Sponsor:
Information provided by (Responsible Party):
Dorthe Thisted, Hvidovre University Hospital

Brief Summary:

Pregnant women with pre-eclampsia and growth restricted fetuses often have a reduced function of the placenta. This is accompanied by an increased perinatal mortality and morbidity.

By ultrasound it is possible to measure blood flow and vascular resistance in both the fetal umbilical cord and in the blood vessels supplying the uterus. A high resistance in these vessels occur before the child is severely affected.

By immersion in water extracellular fluid is redistributed back into the circulation, and central blood volume increases. Previous studies have shown that maternal minute-volume increases, while blood pressure drops slightly. Also an increased amniotic fluid has been recorded. This has been interpreted as an expression of increased renal blood flow. Immersion into water could increase blood flow in the vessels supplying the uterus and thus increase blood flow to the child.

The investigators aim to clarify this by examining blood flow and resistance in the blood vessel supplying the uterus and in the umbilical cord, while the participant is immersed into water. Initially, 25 healthy women with an uncomplicated singleton pregnancy recruited from the Department of Obstetrics and Gynaecology: Hvidovre University Hospital, Denmark, will be examined. The participant will act as its own control and measurements above water and immersed will be conducted at the same study session.

Ultimately the investigators seek to contribute to a non-invasive option for prolonging those pregnancies where the fetus and/or maternal condition requires delivery several weeks before term, and where immersion of the pregnant woman in the water a few hours one to several times daily, may prolong the pregnancy the required number of hours/days for antenatal steroid treatment to be sufficient.

There are no risks associated with the study and the project team considers it ethical to implement this. The study is not supported by pharmaceutical companies or other groups with economic interests. The project group itself has taken the initiative to study.


Condition or disease Intervention/treatment Phase
Pregnancy Immersion Other: Immersion into water Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Water Immersion and Changes in the Fetoplacental Circulation. A Case-Control Study With the Case as it's Own Control.
Study Start Date : February 2011
Actual Primary Completion Date : March 2012
Actual Study Completion Date : March 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Drinking Water

Arm Intervention/treatment
Experimental: Immersion into water
Normal healthy singleton pregnant women. The case serves as its own control. Measurements of mean arterial pressure, deepest vertical pocket of amnion fluid and Doppler flow in the umbilical and uterine arteries will be assessed before immersion (Baseline), during immersion (Immersion) and after immersion (Post-immersion).
Other: Immersion into water
Measurements of mean arterial pressure, deepest vertical pocket of amnion fluid and Doppler flow in the umbilical and uterine arteries will be assessed before immersion, during immersion and after immersion.




Primary Outcome Measures :
  1. Changes in pulsatility index in umbilical and uterine arteries following immersion into water [ Time Frame: After 5 and 25 minutes of immersion and after 15 and 30 past immersion ]

Secondary Outcome Measures :
  1. Changes in maternal mean arterial pressure and in amniotic fluid following immersion into water [ Time Frame: After 5 and 25 minutes of immersion and after 15 and 30 minutes past immersion ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Singleton pregnant women
  • Normal weight fetuses
  • Normal first trimester combined screening
  • Normal second trimester ultrasound scan for fetal abnormalities

Exclusion Criteria:

  • Cardiovascular disease
  • Thyroid disease
  • Abuse of medication, alcohol- or drugs
  • Medical treatment of hypertension
  • Medical treatment of depression or any other psychiatric disorder
  • Ongoing infection
  • Placenta previa
  • Cerclage
  • Premature rupture of membranes
  • Body mass index above 35

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01799343


Locations
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Denmark
Dep. Gynaecology and Obstetrics, Hvidovre University Hospital
Hvidovre, Denmark, 2650
Sponsors and Collaborators
Hvidovre University Hospital
Investigators
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Study Chair: Niels Jørgen Secher, Prof., MD Dep. Gynaecology and Obstetrics, Hvidovre University Hospital
Principal Investigator: Dorthe LA Thisted, MD Dep. Gynaecology and Obstetrics, Hvidovre University Hospital
Publications:

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Responsible Party: Dorthe Thisted, Specialist trainee, Hvidovre University Hospital
ClinicalTrials.gov Identifier: NCT01799343    
Other Study ID Numbers: H-4-2010-139
2011-41-5889 ( Registry Identifier: The Danish Data Protection Agency )
First Posted: February 26, 2013    Key Record Dates
Last Update Posted: February 26, 2013
Last Verified: February 2013
Keywords provided by Dorthe Thisted, Hvidovre University Hospital:
Prenatal care
Blood flow velocity
Hydrotherapy
Fetalplacental circulation
Uteroplacental circulation