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

November 29, 2023 updated by: University Hospitals, Leicester
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Maternal cardiovascular physiology evolves during the course of pregnancy to accommodate the growing foetus. In order that the uterine artery can deliver 10% of the entire maternal cardiac output, there are considerable structural and physiological changes that take place. There is a 30% increase in global arterial compliance, predominantly due to vasodilation at the level of the renal arteries, which leads to a reduced total peripheral resistance. Stroke volume increases due to the plasma expansion and increasing total blood volume. All water compartments show an absolute and relative increase with advancing gestation and eventually water represents the largest component of weight gain in pregnancy. These changes have been measured and known to clinicians for decades. Yet, it is only in the recent past, that the possible clinical relevance of assessing total body water and extracellular body water has been enhanced by the cross over of hypertensive disorders of pregnancy with obesity epidemics.

Bio-electrical impedance analysis (BIA) measures whole body (or regional) impedance by means of an electric current transmitted at different frequencies. New techniques allow measurement of total body water with separation into extracellular and intracellular water. Current evidence suggests that BIA may provide useful information not only in different well-established patient groups (renal dialysis, malnutrition), but also in critically ill patients with burns, trauma and sepsis undergoing fluid resuscitation.

There are a limited number of studies assessing the use of BIA during pregnancy. In a longitudinal study of 126 pregnant women, Piuri and colleagues assessed changes of bio-impedance analysis among low-risk pregnant woman recruited in the first trimester and followed their progress. They found that women who developed hypertensive disorders of pregnancy (HDP) showed significantly different bioimpedance from control cases. Total Body Water (TBW)indices were highly significantly different from the first trimester. In pregnancies delivered of small for gestational age (SGA) newborns, these indices were the opposite of the values observed in patients with HDP-average for gestational age (AGA).TBW in these patients was significantly reduced compared with normal pregnancies. The authors concluded that the bioelectrical impedance is a fast, simple, noninvasive way to assess the TBW content in pregnancy and bio-impedance might help to identify, early in gestation, patients at risk of developing different clinical phenotypes of hypertensive disease of pregnancy and SGA fetuses.

In a prospective observational study of 3000 pregnant women, Kent and colleagues examined the use of multi frequency segmental bioelectric impedance analysis in the first trimester of pregnancy for assessment of maternal body composition as predictors of increased birth weight. They observed that on direct measurements of body composition, birth weight correlated positively with maternal fat-free mass and not adiposity.

Several factors may influence the progression of normal labour. It has been postulated that the routine administration of intravenous fluids to keep women adequately hydrated during labour may reduce the period of contraction and relaxation of the uterine muscle, and may ultimately reduce the duration of the labour. It has also been suggested that intravenous fluids may reduce caesarean section rates (CS) for prolonged labour. Conversely, excessive volumes of intravenous fluids may pose risks to both the mother and her new-born with different fluids being associated with different risks.

In a Cochrane systematic review, Dawood and colleagues reported that administration of intravenous fluids compared with oral intake alone demonstrated a reduction in the duration of labour. The findings of other trials suggested that if a policy of no oral intake is applied, then the duration of labour in nulliparous women may be shortened by the administration of intravenous fluids at a rate of 250 ml/hour rather than 125ml/hour. However, there was no objective assessment of hydration status.

However, the benefits of routine administration of intravenous fluids to labouring women has not been adequately elucidated although it is a widely-adopted policy, and there is no consensus on the type or volume of fluid that are required, or indeed, whether intravenous fluids are at all necessary. Women may be able to adequately hydrate themselves if they were allowed oral fluids during labour.

Enhanced recovery was initially introduced for patients having minimally-invasive laparoscopic surgery. Following its introduction in colorectal surgery, it is now advocated for many other specialities including Obstetrics. Enhanced recovery has transformed the delivery of perioperative practice. The core ethos of enhanced recovery is to speed up a patient's recovery after surgery and improve patient outcomes, with associated benefits for staff and healthcare systems.

Patients are given clear instructions about fluid and food intake before the operation. Currently there is limited data about hydration state at the time of admission for operation. Women having their operation on the morning of admission are advised to follow the following instructions: a) they should not eat food after 0200h. b) They can drink water until 0600h. c) At 0600h women should consume 400ml (2x 200ml bottles supplied at outpatient 'pre-clerking' clinic) of high energy carbohydrate drink before they attend hospital. Women should then remain nil by mouth, unless advised differently by the hospital team. Ranitidine and all routine medications (unless directed otherwise on the intrapartum care plan) should be taken at 0600h. Women having operations in the afternoon are advised a) to have light breakfast such as cereal, toast and fruit. b) Women should not eat food after 0600h but may drink water until 1000h.

Hypertensive disorders during pregnancy carry risks for the mother and the baby and it is one of the leading causes of maternal morbidity and mortality death in the worldwide. A UK study reported that one-third of severe maternal morbidity was a consequence of hypertensive conditions and a study conducted in the USA found that over half of admissions for acute kidney failure, one-quarter of admissions for coagulopathy and nearly one-third of admissions for ventilation or cerebrovascular disorders occurred in women with hypertensive disorders.

In a semi-longitudinal cohort study from Italy, Wilfried and colleagues examined changes in body fluid composition using Bioimpedance analyser of women with early onset preeclampsia (75 subjects) and late onset preeclampsia (117 subjects) and compared results to healthy controls. They observed significant difference in extracellular water among women with preeclampsia across trimesters. However, changes in body fluid and degree of severity of pre-eclampsia were not examined before. Other conditions that could affect body composition of water during pregnancy includes hyperemesis gravidarum, poor renal or cardiac function, major postpartum haemorrhage, and sepsis.

Study Type

Observational

Enrollment (Estimated)

900

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United Kingdom
    • Leicestershire
      • Leicester, Leicestershire, United Kingdom, LE1 5WW
        • Recruiting
        • Univercity Hospitals of Leicester NHS Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Cesarean section
Women attending for elective CS.
Other: Bioimpedance Analyser
Bio-electrical impedance analysis (BIA) measures whole body (or regional) impedance by means of an electric current transmitted at different frequencies.
Induction of labour
Women admitted for induction of labour and expected to stayed in hospital for more than 24 hours.
Other: Bioimpedance Analyser
Bio-electrical impedance analysis (BIA) measures whole body (or regional) impedance by means of an electric current transmitted at different frequencies.
pregnancy complication group

Maternal condition that could affect body fluid including:

  • Pre-eclampsia requiring hospital admission.
  • Hyperemesis gravidarum.
  • Major postpartum haemorrhage.
Other: Bioimpedance Analyser
Bio-electrical impedance analysis (BIA) measures whole body (or regional) impedance by means of an electric current transmitted at different frequencies.
control
Gestational age matched controls.
Other: Bioimpedance Analyser
Bio-electrical impedance analysis (BIA) measures whole body (or regional) impedance by means of an electric current transmitted at different frequencies.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bioimpedance assessment of hydration status
Time Frame: on admission
assessment of extracellular and intra-cellular body fluid using Bio-electrical impedance analysis and comparing results to standard fluid chart.
on admission

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospitals, Leicester

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 8, 2019

Primary Completion (Estimated)

March 1, 2024

Study Completion (Estimated)

October 1, 2024

Study Registration Dates

First Submitted

January 28, 2019

First Submitted That Met QC Criteria

January 29, 2019

First Posted (Actual)

January 31, 2019

Study Record Updates

Last Update Posted (Actual)

December 6, 2023

Last Update Submitted That Met QC Criteria

November 29, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • Edge ID 120909

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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