Assessing body water changes in pregnant women using bioimpedance analysis
Bioimpedance In Pregnancy and Labour: A Fluid Balance Concept Study.
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 |
|---|---|
| Enrollment | 900 (estimated) |
| Ages | 16 Years and up |
| Sex | Female |
| Sponsor | University Hospitals, Leicester Academic / other |
| Locations | 1 site (Leicester, Leicestershire) |
| Trial ID | NCT03823820 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Leicester, Leicestershire
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.