Pregnancy Clinical Trial
Official title:
Water Immersion and Changes in the Fetoplacental Circulation. A Case-Control Study With the Case as it's Own Control.
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.
Status | Completed |
Enrollment | 25 |
Est. completion date | March 2012 |
Est. primary completion date | March 2012 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
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 |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Denmark | Dep. Gynaecology and Obstetrics, Hvidovre University Hospital | Hvidovre |
Lead Sponsor | Collaborator |
---|---|
Hvidovre University Hospital |
Denmark,
Cnossen JS, Morris RK, ter Riet G, Mol BW, van der Post JA, Coomarasamy A, Zwinderman AH, Robson SC, Bindels PJ, Kleijnen J, Khan KS. Use of uterine artery Doppler ultrasonography to predict pre-eclampsia and intrauterine growth restriction: a systematic review and bivariable meta-analysis. CMAJ. 2008 Mar 11;178(6):701-11. doi: 10.1503/cmaj.070430. Review. — View Citation
Elvan-Taspinar A, Franx A, Delprat CC, Bruinse HW, Koomans HA. Water immersion in preeclampsia. Am J Obstet Gynecol. 2006 Dec;195(6):1590-5. Epub 2006 Jul 26. — View Citation
Epstein M, Duncan DC, Fishman LM. Characterization of the natriuresis caused in normal man by immersion in water. Clin Sci. 1972 Aug;43(2):275-87. — View Citation
Epstein M, Miller M, Schneider N. Depth of immersion as a determinant of the natriuresis of water immersion. Proc Soc Exp Biol Med. 1974 Jun;146(2):562-6. — View Citation
Epstein M, Norsk P, Loutzenhiser R, Sonke P. Detailed characterization of a tank used for head-out water immersion in humans. J Appl Physiol (1985). 1987 Aug;63(2):869-71. — View Citation
Epstein M. Renal, endocrine and hemodynamic effects of water immersion in man. Contrib Nephrol. 1984;41:174-88. — View Citation
Greenleaf JE. Physiological responses to prolonged bed rest and fluid immersion in humans. J Appl Physiol Respir Environ Exerc Physiol. 1984 Sep;57(3):619-33. Review. — View Citation
Katz VL. Exercise in water during pregnancy. Clin Obstet Gynecol. 2003 Jun;46(2):432-41. Review. — View Citation
Katz VL. Water exercise in pregnancy. Semin Perinatol. 1996 Aug;20(4):285-91. Review. — View Citation
Kwee A, Graziosi GC, Schagen van Leeuwen JH, van Venrooy FV, Bennink D, Mol BW, Cohlen BJ, Visser GH. The effect of immersion on haemodynamic and fetal measures in uncomplicated pregnancies of nulliparous women. BJOG. 2000 May;107(5):663-8. — View Citation
Marsál K. Obstetric management of intrauterine growth restriction. Best Pract Res Clin Obstet Gynaecol. 2009 Dec;23(6):857-70. doi: 10.1016/j.bpobgyn.2009.08.011. Epub 2009 Oct 24. Review. — View Citation
San Juan Dertkigil M, Cecatti JG, Sarno MA, Cavalcante SR, Marussi EF. Variation in the amniotic fluid index following moderate physical activity in water during pregnancy. Acta Obstet Gynecol Scand. 2007;86(5):547-52. — View Citation
* Note: There are 12 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Changes in pulsatility index in umbilical and uterine arteries following immersion into water | After 5 and 25 minutes of immersion and after 15 and 30 past immersion | Yes | |
Secondary | Changes in maternal mean arterial pressure and in amniotic fluid following immersion into water | After 5 and 25 minutes of immersion and after 15 and 30 minutes past immersion | Yes |
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