Assessing body water changes in pregnant women using bioimpedance analysis
Official title: Bioimpedance In Pregnancy and Labour: A Fluid Balance Concept Study.
Run by University Hospitals, Leicester · NCT03823820 · Data updated 2026-11-12
This study tests a simple bedside test to see how body water changes during pregnancy in women with different medical conditions.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 16 Years and up |
| Sex | Women only |
| Enrollment | 900 (estimated) |
| Sponsor | University Hospitals, Leicester Academic / other |
| Locations | 1 site (Leicester, Leicestershire) |
| Status | Recruiting |
| Started | April 8, 2019 |
| Main results expected | February 14, 2029 |
| Study ends | February 14, 2029 |
| Registry record updated | January 5, 2026 |
| Trial ID | NCT03823820 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include pregnant women aged 16 and over with viable pregnancies, particularly those undergoing elective cesarean sections or induction of labor, as well as those with conditions like pre-eclampsia or hyperemesis gravidarum.
✕Probably not a fit
Patients who may not benefit include those under 16 years of age, individuals unable to provide consent, and those with learning disabilities or requiring pacemakers.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study aims to evaluate how a simple bedside test can provide insights into changes in body water content during pregnancy. It focuses on understanding the impact of various medical conditions on hydration levels in pregnant women. By utilizing bio-electrical impedance analysis (BIA), the study seeks to measure total body water and differentiate between extracellular and intracellular water. The research will involve pregnant women undergoing elective cesarean sections, those being induced for labor, and women with specific maternal conditions affecting fluid balance.
Why it matters
Potential benefit: If successful, this study could enhance the management of hydration in pregnant women, potentially improving maternal and fetal outcomes.
How similar studies have gone: While the use of bioimpedance analysis has been established in other patient groups, this specific application in pregnant women is relatively novel and has not been extensively tested.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
-
Univercity Hospitals of Leicester NHS Trust
Leicester, Leicestershire, United Kingdom Recruiting
Study contacts
- Study coordinator: Tommy Mousa
- Email: tommy.mousa@uhl-tr.nhs.uk
- Phone: 0116 258 7770
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.