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New device could track hydration in pregnancy without needles

NCT ID NCT03823820

Knowledge-focused Sponsor: University Hospitals, Leicester Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study is testing a simple bedside device called a bioimpedance analyser to measure body water changes in pregnant women. Researchers will compare its readings to standard fluid charts in 900 women, including those having planned C-sections, induced labor, or conditions like pre-eclampsia. The goal is to see if this non-invasive tool can reliably track hydration status during pregnancy and labor.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Bioimpedance analyser (device)
What this could lead to
If successful, this could lead to a simple, non-invasive way to monitor hydration in pregnant women, potentially improving care during labor and for conditions like pre-eclampsia.
What could go wrong
This is an early observational study, not a treatment trial. The device may not prove accurate enough to replace current methods, and results may not apply to all pregnancies.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 900 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2019

Expected to finish

Feb 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Pregnant women admitted for caesarean section, induction of labour or has a medical condition that affect amount of fluid inside the body.

Ages

16 years and older

Sex

Female participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

hyperemesis gravidarum preeclampsia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Hydration

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Univercity Hospitals of Leicester NHS Trust

    RECRUITING

    Leicester, Leicestershire, LE1 5WW, United Kingdom

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