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

NCT03823820 | Recruiting

• 1 other identifier: Edge ID 120909
• Study Type: observational
• Target: 900
• Locations: 1 country
• Sites: 1

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.

Conditions

Hydration

Outcome Measures

Primary Outcomes (1)

• Bioimpedance assessment of hydration status

  assessment of extracellular and intra-cellular body fluid using Bio-electrical impedance analysis and comparing results to standard fluid chart.

  on admission

Study Arms (4)

Cesarean section

Women attending for elective CS.

Other: Bioimpedance Analyser

Induction of labour

Women admitted for induction of labour and expected to stayed in hospital for more than 24 hours.

Other: Bioimpedance Analyser

pregnancy complication group

Maternal condition that could affect body fluid including: * Pre-eclampsia requiring hospital admission. * Hyperemesis gravidarum. * Major postpartum haemorrhage.

Other: Bioimpedance Analyser

control

Gestational age matched controls.

Other: Bioimpedance Analyser

Interventions

Bioimpedance Analyser OTHER

Bio-electrical impedance analysis (BIA) measures whole body (or regional) impedance by means of an electric current transmitted at different frequencies.

Cesarean section; Induction of labour; control; pregnancy complication group

Eligibility Criteria

• Age: 16 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospitals, Leicester: lead

Study Sites (1)

Univercity Hospitals of Leicester NHS Trust

Leicester, Leicestershire, LE1 5WW, United Kingdom

RECRUITING

Related Publications (19)

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  PMID: 13649774 BACKGROUND

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  PMID: 13130691 BACKGROUND

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• Piuri G, Ferrazzi E, Bulfoni C, Mastricci L, Di Martino D, Speciani AF. Longitudinal changes and correlations of bioimpedance and anthropometric measurements in pregnancy: Simple possible bed-side tools to assess pregnancy evolution. J Matern Fetal Neonatal Med. 2017 Dec;30(23):2824-2830. doi: 10.1080/14767058.2016.1265929. Epub 2016 Dec 14.

  PMID: 27892802 BACKGROUND

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  PMID: 23232753 BACKGROUND

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  PMID: 23780639 BACKGROUND

• 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.

  BACKGROUND

• The Association of Anaesthetists of Great Britain and Ireland. Immediate Postanaesthetic Recovery. September 2002. www.aagbi.org.

  BACKGROUND

• NICE Advice QP Case Study Published November 2009 Last updated May 2016

  BACKGROUND

• DOH Nov 2009. Enhanced Recovery for Elective Surgery. www.evidence.nhs.uk/qualityand productivity

  BACKGROUND

• 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.

  BACKGROUND

• Management of adults with diabetes undergoing surgery and elective procedures: Improving standards (revised 2016). The Joint British Diabetes Societies for inpatient care. Diabetes UK.

  BACKGROUND

• Enhanced Recovery for Elective Caesarean Sections. University of Leicester Working Party. Guideline Register No: C15/2017.

  BACKGROUND

• Knight M; UKOSS. Eclampsia in the United Kingdom 2005. BJOG. 2007 Sep;114(9):1072-8. doi: 10.1111/j.1471-0528.2007.01423.x. Epub 2007 Jul 6.

  PMID: 17617191 BACKGROUND

• Lyons G. Saving mothers' lives: confidential enquiry into maternal and child health 2003-5. Int J Obstet Anesth. 2008 Apr;17(2):103-5. doi: 10.1016/j.ijoa.2008.01.006. Epub 2008 Mar 4. No abstract available.

  PMID: 18308550 BACKGROUND

• Schutte JM, Schuitemaker NW, van Roosmalen J, Steegers EA; Dutch Maternal Mortality Committee. Substandard care in maternal mortality due to hypertensive disease in pregnancy in the Netherlands. BJOG. 2008 May;115(6):732-6. doi: 10.1111/j.1471-0528.2008.01702.x.

  PMID: 18410657 BACKGROUND

• Waterstone M, Bewley S, Wolfe C. Incidence and predictors of severe obstetric morbidity: case-control study. BMJ. 2001 May 5;322(7294):1089-93; discussion 1093-4. doi: 10.1136/bmj.322.7294.1089.

  PMID: 11337436 BACKGROUND

• Kuklina EV, Ayala C, Callaghan WM. Hypertensive disorders and severe obstetric morbidity in the United States. Obstet Gynecol. 2009 Jun;113(6):1299-1306. doi: 10.1097/AOG.0b013e3181a45b25.

  PMID: 19461426 BACKGROUND

• Gyselaers W, Vonck S, Staelens AS, Lanssens D, Tomsin K, Oben J, Dreesen P, Bruckers L. Body fluid volume homeostasis is abnormal in pregnancies complicated with hypertension and/or poor fetal growth. PLoS One. 2018 Nov 1;13(11):e0206257. doi: 10.1371/journal.pone.0206257. eCollection 2018.

  PMID: 30383796 BACKGROUND

Central Study Contacts

Tommy Mousa

CONTACT

0116 258 7770; tommy.mousa@uhl-tr.nhs.uk

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 28, 2019
• First Posted: January 31, 2019
• Study Start: April 8, 2019
• Primary Completion (Estimated): February 14, 2029
• Study Completion (Estimated): February 14, 2029
• Last Updated: January 5, 2026

Record last verified: 2025-12

Locations

GB (1)