RecruitingOBSERVATIONAL

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

This study aims to understand changes in a pregnant woman's body water content using a simple, non-invasive test called a Bioimpedance Analyser. During pregnancy, a woman’s body naturally changes a lot, including how much fluid it holds. We want to see if various medical conditions can influence these fluid levels. By understanding these changes better, healthcare professionals might be able to monitor a woman's health more effectively throughout her pregnancy. The study focuses on gathering more information about this test and its usefulness, particularly as pregnancy-related high blood pressure is becoming more common alongside obesity.

At a glance

Status

Recruiting

Sponsor

University Hospitals, Leicester

Enrolment target

900

Start

08 Apr 2019

Estimated completion

14 Feb 2029

Hydration

What is this study about?

During pregnancy, a woman's body undergoes many amazing changes to support her growing baby. One of these important changes involves how much fluid or water her body holds. This study is looking into a simple, straightforward test called a Bioimpedance Analyser to help us understand these body fluid changes better. We're particularly interested in seeing if different health conditions that can happen during pregnancy might affect how these fluid levels naturally shift.

Traditionally, doctors have known about these fluid changes for a long time, but new ways to measure body water — including separating it into fluid inside and outside cells — are becoming more advanced. This new technology could offer helpful insights, especially as we see more cases of high blood pressure during pregnancy, sometimes linked to obesity. Understanding fluid balance can be really important for managing these conditions.

This research is about gathering more information about how useful this Bioimpedance Analyser test is during pregnancy. While it's used in other medical areas, there haven't been many studies specifically for pregnant women. Previous research suggests this test might be able to spot differences in body fluid that could be important, for example, in women who develop high blood pressure during pregnancy.

Key takeaways

This study uses a simple test to understand body fluid changes in pregnancy.
It aims to see if medical conditions affect these fluid levels.
The test (Bioimpedance Analyser) is safe, quick, and non-invasive.
No new medicines are involved in this research.
The findings could help improve care for pregnant women in the future.
You can stop participating at any time without affecting your care.

Who may be eligible?

You might be able to take part in this study if you are at least 16 years old, pregnant with a healthy baby, and fit into one of these groups: a) you are having a planned caesarean section; b) you are coming into the hospital to start your labour and expect to stay for more than 24 hours; c) you have a specific medical condition that affects your body fluids, such as severe morning sickness requiring hospital stay, high blood pressure in pregnancy (pre-eclampsia) needing hospital admission, or significant bleeding after birth (1 litre or more); or d) you are a healthy pregnant woman acting as a comparison for the other groups.

However, there are reasons why you might not be able to join. These include if you are under 16, can't give your consent freely, have learning difficulties, can't speak or read English well enough, or are a prisoner. Also, if you have a pacemaker or defibrillator, this study would not be suitable for you. The researchers also have a duty to keep vulnerable people safe, so if you're in a group deemed particularly vulnerable, you might not be able to participate.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 16 years old or older and pregnant with a healthy baby?
Are you having a planned caesarean section OR starting labour at the hospital (expecting to stay over 24 hours)?
Do you currently have (or recently had) certain pregnancy conditions like severe sickness, high blood pressure in pregnancy (pre-eclampsia), or significant bleeding after birth?
Can you give informed consent and read/speak English well enough?
Do you NOT have a pacemaker or defibrillator?

Answer every question to see your result.

What does participation involve?

The study involves using a Bioimpedance Analyser, which is a simple, quick test. This device measures your body's water content by sending a very small, harmless electrical current through your body, similar to what some home fitness scales do. This test is non-invasive and easy to perform by your bedside. You won't need to take any new medications as part of this study. The exact number of visits or assessments will depend on which group you are in, but it will involve measuring your body water at different points during and potentially after your pregnancy. The overall duration of your involvement will vary depending on your individual circumstances, but you will be informed of all time commitments upfront.

Potential risks and benefits

Taking part in this study may not directly benefit you, but the information we gather will help doctors understand more about body fluid changes in pregnancy and potentially improve care for future pregnant women. The Bioimpedance Analyser is a very safe test with no known risks to you or your baby. It's a non-invasive procedure, meaning no needles or discomfort. You are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Univercity Hospitals of Leicester NHS Trust
Verified postcode
Leicester, United Kingdom· Recruiting

Common questions

What is a Bioimpedance Analyser?

It's a simple, safe device that measures your body's water content using a harmless electrical current, similar to smart scales.

Will taking part in this study hurt me or my baby?

No, the test is non-invasive, meaning no needles or discomfort, and uses a very low, safe electrical current, posing no risk to you or your baby.

Do I have to take any new medicines for this study?

No, this study does not involve taking any new medications. It only uses the Bioimpedance Analyser test.

How long will I be involved in the study?

The length of your involvement will depend on which group you are in, but you will be told all the details about the time commitments before you agree to participate.

Can I leave the study if I change my mind?

Yes, you can withdraw from the study at any time, for any reason, without it affecting your medical care.

How to find out more

Tommy Mousa

tommy.mousa@uhl-tr.nhs.uk 0116 258 7770 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.