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Bioimpedance In Pregnancy and Labour: A Fluid Balance Concept Study. (BiPAL)

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03823820
Recruitment Status : Not yet recruiting
First Posted : January 31, 2019
Last Update Posted : April 4, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospitals, Leicester

Brief Summary:
The purpose of our study is to find out if using a simple bed side test can tell us information about changes that occur in women's body water content. We would like to check if certain medical conditions could affect body water contents.

Condition or disease Intervention/treatment
Hydration Other: Bioimpedance Analyser

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Study Type : Observational
Estimated Enrollment : 900 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Bioimpedance In Pregnancy and Labour: A Fluid Balance Concept Study.
Estimated Study Start Date : April 15, 2019
Estimated Primary Completion Date : March 1, 2024
Estimated Study Completion Date : October 1, 2024

Group/Cohort Intervention/treatment
Cesarean section
Women attending for elective CS.
Other: Bioimpedance Analyser
Bio-electrical impedance analysis (BIA) measures whole body (or regional) impedance by means of an electric current transmitted at different frequencies.

Induction of labour
Women admitted for induction of labour and expected to stayed in hospital for more than 24 hours.
Other: Bioimpedance Analyser
Bio-electrical impedance analysis (BIA) measures whole body (or regional) impedance by means of an electric current transmitted at different frequencies.

pregnancy complication group

Maternal condition that could affect body fluid including:

  • Pre-eclampsia requiring hospital admission.
  • Hyperemesis gravidarum.
  • Major postpartum haemorrhage.
Other: Bioimpedance Analyser
Bio-electrical impedance analysis (BIA) measures whole body (or regional) impedance by means of an electric current transmitted at different frequencies.

control
Gestational age matched controls.
Other: Bioimpedance Analyser
Bio-electrical impedance analysis (BIA) measures whole body (or regional) impedance by means of an electric current transmitted at different frequencies.




Primary Outcome Measures :
  1. Bioimpedance assessment of hydration status [ Time Frame: on admission ]
    assessment of extracellular and intra-cellular body fluid using Bio-electrical impedance analysis and comparing results to standard fluid chart.



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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Pregnant women admitted for caesarean section, induction of labour or has a medical condition that affect amount of fluid inside the body.
Criteria

Inclusion Criteria: pregnant women at age of 16 or over with a viable pregnancy and who will fulfil the following:

  • Group I: Women attending for elective CS.
  • Group II: Women admitted for induction of labour and expected to stay stay in hospital for more than 24 hours.
  • Group III: Maternal condition that could have direct impact on body fluid including:

    1. Pre-eclampsia requiring hospital admission.
    2. Hyperemesis gravidarum requiring hospital admission.
    3. Major postpartum haemorrhage (equal or greater than 1000 ml following delivery).
  • Group IV: gestational age matched controls.

Exclusion criteria:

  • Maternal age less than 16 years at booking.
  • Women who are not capable of giving consent.
  • Women with learning disabilities/difficulties.
  • Unable to speak or read English to the appropriate level.
  • Prisoners.
  • Any others deemed to belong to a vulnerable group.
  • Women who require pace maker or defibrillators.
Publications:
The Association of Anaesthetists of Great Britain and Ireland Obstetric Anaesthetists' Association (2000). OAA/AAGBI Guidelines for Obstetric Anaesthetic Services Revised Edition 2005. London: The Association of Anaesthetists of Great Britain and Ireland Obstetric Anaesthetists' Association.
The Association of Anaesthetists of Great Britain and Ireland. Immediate Postanaesthetic Recovery. September 2002. www.aagbi.org.
NICE Advice QP Case Study Published November 2009 Last updated May 2016
DOH Nov 2009. Enhanced Recovery for Elective Surgery. www.evidence.nhs.uk/qualityand productivity
Gregory, R et al. Can pre-operative carbohydrate loading be used in diabetic patients undergoing colorectal surgery? British Journal of Diabetes. 2011: Vol 14-3. P102-4.
Management of adults with diabetes undergoing surgery and elective procedures: Improving standards (revised 2016). The Joint British Diabetes Societies for inpatient care. Diabetes UK.
Enhanced Recovery for Elective Caesarean Sections. University of Leicester Working Party. Guideline Register No: C15/2017.

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Responsible Party: University Hospitals, Leicester
ClinicalTrials.gov Identifier: NCT03823820    
Other Study ID Numbers: Edge ID 120909
First Posted: January 31, 2019    Key Record Dates
Last Update Posted: April 4, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No