AzTrials
AzTrials

PregnancyNCT01799343

Water Immersion and Changes in the Fetoplacental Circulation

A study testing Immersion into water in people with Pregnancy and Immersion, run by Hvidovre University Hospital at 1 site in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women onlyHealthy volunteers can take part
Conditions the study is for
Pregnancy, Immersion
What is being tested?
Immersion into water
Could I receive a placebo?
No, everyone receives an active treatment
How many people
25 participants
Where
1 siteDenmark
Study dates
Feb 2011to Mar 2012
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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
Show all 10Show fewer
  • Placenta previa
  • Cerclage
  • Premature rupture of membranes
  • Body mass index above 35

Trial locations and contacts

1 site in 1 country.

Denmark1 site
  • Dep. Gynaecology and Obstetrics, Hvidovre University Hospital

    Hvidovre, Hvidovre, 2650

Other trials in Denmark

About this study

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.

Read more

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.

Read the detailed description

Intrauterine growth retardation and preeclampsia are major causes of neonatal mortality, morbidity and later neurological sequelae. The conditions are associated with an increased resistance to blood flow in the placenta, that can be detected by an increase in pulsatility index (PI) in the umbilical artery (1).

When Doppler flow is assessed in the uterine arteries, increased resistance in the uteroplacental circuit is indicated both by an increase in PI and by a change in the flow velocity waveform, which can be seen as a "notch" in early diastole.

In the 2nd trimester, the invasion of trophoblasts and the remodeling of the uterine spiral arteries are complete. Persistence of a bilateral notch beyond the 24th week of gestation is associated with an increased risk of intrauterine growth retardation and preeclampsia. Even though the risk persists, the notch usually disappears later in pregnancy (2).

When the non-pregnant body is immersed in water, extracellular fluid is redistributed back into the circulation. Central blood volume, cardiac output, renal perfusion and urine output increase and the blood pressure falls (3-7).

The same changes occur in the pregnant women. However the increased diuresis is strongly correlated with the degree of the pregnancy edema, which decreases substantially (8), and the amount of amniotic fluid increases (9). The changes all occur within minutes (8), but are transient and return to conditions before immersion within 1-2 hours after the pregnant woman has come out of the water.

The changes in the above parameters are significant but less pronounced in pregnant women with preeclampsia than in pregnant women without the condition (11). None of the experiments showed changes in the fetal heart rate.

Because of the physiological changes that take place when pregnant women are immersed in water, several authors have speculated whether immersion has a positive effect on the uteroplacental circuit (8,10,12).

There are no published data on Doppler flow measurements in the umbilical artery and the uterine arteries during water immersion.

The aim of the present study is to evaluate the effect of immersion on the fetoplacental and uteroplacental circuits in healthy pregnant women, using Doppler flow measurements in the umbilical artery and uterine arteries.

Materials From the Department of Obstetrics and Gynecology, Hvidovre University Hospital, Denmark, we recruit 25 healthy women with an uncomplicated singleton pregnancy. Gestational age was between 26 and 38 weeks. All participants will have a normal first trimester combined screening and a normal second trimester ultrasound scan for fetal abnormalities. Within the last 2 weeks prior to participation, fetal weight will be estimated, and only woman with fetuses of normal weight (within the 95 percentile) will be included.

Methods The study is performed at the labor ward at Hvidovre Hospital, Denmark. If fetal weight has not been estimated by an ultrasound examination within the last 2 weeks, fetal weight will be estimated on the day of the study. In order to exclude an on-going infection, the temperature is measured and the urine examined in all participants on the day of the study.

The same experienced sonographer performs all examinations, and the same Bruel \& Kjaer ultrasound scanner, suitable for scanning under water, is used in all participants.

Each participant has five recordings of blood pressure, pulse, saturation, deepest vertical pocket (DVP) of amniotic fluid and Doppler flow in the umbilical artery and uterine arteries. All recordings are obtained during the same study session. Doppler ultrasound measurements of umbilical and uterine arteries are obtained by pulsed wave ultrasound using an insonating angle as close to 0 degrees as possible. The Doppler measurements on the uterine arteries are obtained approximately one centimeter from the crossing of the iliac arteries. The pulsatility index (PI) is calculated automatically by the machine using the formula (systolic velocity-diastolic velocity)/mean velocity. PI of the uterine artery is calculated as the mean PI of the left and the right uterine artery.

For immersion, a regular bathtub is used. The tub is filled with thermo-neutral tap water (35.0 °C +/- 0.5 °C). The temperature of the water is measured every 10 minutes, and kept thermo-neutral during the period of immersion.

The participants are placed in a supine position outside the bathtub and the first recordings are obtained (T0). Afterwards the participants are immersed in water, placed in a supine position, and measurements are repeated after 5 min (T5) and 25 min (T25) in water. All measurements are repeated with the participant in a supine position outside the bathtub 15 min (T40) and 30 min (T55) after immersion.

All recordings of Doppler flow curves and measurements of amniotic fluid (DVP) are saved on an USB stick. An experienced specialist in fetal medicine, who is not present at the investigation, validates each recording blindly. Any recording not eligible for approval is redefined as a missing value.

Statistical analysis Because the measurements taken before, during and after immersion, are made in the same patient during the same study session, and with the same ultrasound apparatus, each participant act as their own control.

Data are expressed as means +/- standard error of the mean (SEM). The first recording, T0, was defined as baseline. Comparisons between the respective recordings, T0-T55, are done using a two-tailed paired t-test on raw data. P-values < 0.05 are considered significant. For calculation, STATA 12.1 (13) is used.

Conditions
Pregnancy, Immersion
Being tested
Immersion into water
Keywords
Prenatal care, Blood flow velocity, Hydrotherapy, Fetalplacental circulation, Uteroplacental circulation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Immersion into waterOther

    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.

Study groups in NCT01799343
Study groupRoleWhat they receive
Immersion into waterExperimentalNormal 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).
Receives: Other: Immersion into water

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Changes in pulsatility index in umbilical and uterine arteries following immersion into water

    Measured: After 5 and 25 minutes of immersion and after 15 and 30 past immersion

Secondary outcomes (1)
  1. Changes in maternal mean arterial pressure and in amniotic fluid following immersion into water

    Measured: After 5 and 25 minutes of immersion and after 15 and 30 minutes past immersion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Feb 2013 (estimated)
  2. Study startFeb 2011
  3. Primary completionMar 2012
  4. Study completionMar 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
25 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01799343
Sponsor's protocol ID
H-4-2010-139
Other IDs
2011-41-5889
Status last verified
Feb 2013
First submitted
21 Feb 2013
Last updated
26 Feb 2013
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 19854682
  • 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.

    PubMed 18332385
  • 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.

    PubMed 4834465
  • 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.

    PubMed 3654446
  • 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.

    PubMed 5048310
  • 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.

    PubMed 6570093
  • 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.

    PubMed 6386766
  • Katz VL. Water exercise in pregnancy. Semin Perinatol. 1996 Aug;20(4):285-91. doi: 10.1016/s0146-0005(96)80021-8.

    PubMed 8888454
  • 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.

    PubMed 17464582
  • 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.

    PubMed 10826583
  • 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.

    PubMed 16875643
  • 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.

    PubMed 12808393

Questions about this trial

What is this clinical trial studying?

A study testing Immersion into water in people with Pregnancy and Immersion, run by Hvidovre University Hospital at 1 site in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01799343, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2013.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in