Water Immersion and Changes in the Fetoplacental Circulation
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01799343|
Recruitment Status : Completed
First Posted : February 26, 2013
Last Update Posted : February 26, 2013
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|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||25 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Single (Outcomes Assessor)|
|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|
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.
- 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 ]
- 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 ]
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
|Dep. Gynaecology and Obstetrics, Hvidovre University Hospital|
|Hvidovre, Denmark, 2650|
|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|