Water Immersion and Changes in the Fetoplacental Circulation

NCT01799343 | Completed

• 2 other identifiers: H-4-2010-1392011-41-5889
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Pregnancy; Immersion

Keywords

Prenatal care; Blood flow velocity; Hydrotherapy; Fetalplacental circulation; Uteroplacental circulation

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• 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

Study Arms (1)

Immersion into water

EXPERIMENTAL

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

Interventions

Immersion into water OTHER

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.

Immersion into water

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hvidovre University Hospital: lead

Study Sites (1)

Dep. Gynaecology and Obstetrics, Hvidovre University Hospital

Hvidovre, Hvidovre, 2650, Denmark

Location

Related Publications (12)

• Marsal 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.

  PMID: 19854682 BACKGROUND

• 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.

  PMID: 18332385 BACKGROUND

• 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. doi: 10.3181/00379727-146-38147. No abstract available.

  PMID: 4834465 BACKGROUND

• 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. doi: 10.1152/jappl.1987.63.2.869.

  PMID: 3654446 BACKGROUND

• 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. doi: 10.1042/cs0430275. No abstract available.

  PMID: 5048310 BACKGROUND

• Epstein M. Renal, endocrine and hemodynamic effects of water immersion in man. Contrib Nephrol. 1984;41:174-88. doi: 10.1159/000429282. No abstract available.

  PMID: 6570093 BACKGROUND

• 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. doi: 10.1152/jappl.1984.57.3.619.

  PMID: 6386766 BACKGROUND

• Katz VL. Water exercise in pregnancy. Semin Perinatol. 1996 Aug;20(4):285-91. doi: 10.1016/s0146-0005(96)80021-8.

  PMID: 8888454 BACKGROUND

• 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. doi: 10.1080/00016340601181649.

  PMID: 17464582 BACKGROUND

• 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. doi: 10.1111/j.1471-0528.2000.tb13310.x.

  PMID: 10826583 BACKGROUND

• 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. doi: 10.1016/j.ajog.2006.05.007. Epub 2006 Jul 26.

  PMID: 16875643 BACKGROUND

• Katz VL. Exercise in water during pregnancy. Clin Obstet Gynecol. 2003 Jun;46(2):432-41. doi: 10.1097/00003081-200306000-00022. No abstract available.

  PMID: 12808393 BACKGROUND

Study Officials

• Niels Jørgen Secher, Prof., MD

  Dep. Gynaecology and Obstetrics, Hvidovre University Hospital

  STUDY CHAIR

• Dorthe LA Thisted, MD

  Dep. Gynaecology and Obstetrics, Hvidovre University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Specialist trainee

Study Record Dates

• First Submitted: February 21, 2013
• First Posted: February 26, 2013
• Study Start: February 1, 2011
• Primary Completion: March 1, 2012
• Study Completion: March 1, 2012
• Last Updated: February 26, 2013

Record last verified: 2013-02

Locations

DK (1)