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临床试验/NCT03823820
NCT03823820招募中不适用

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

University Hospitals, Leicester1 个研究点 分布在 1 个国家目标入组 900 人开始时间: 2019年4月8日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
900
试验地点
1
主要终点
Bioimpedance assessment of hydration status

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
16 Years 至 —(Child, Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • 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:
  • Pre-eclampsia requiring hospital admission.
  • Hyperemesis gravidarum requiring hospital admission.
  • Major postpartum haemorrhage (equal or greater than 1000 ml following delivery).
  • Group IV: gestational age matched controls.

排除标准

  • 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.

研究组 & 干预措施

Cesarean section

Women attending for elective CS.

干预措施: Bioimpedance Analyser (Other)

Induction of labour

Women admitted for induction of labour and expected to stayed in hospital for more than 24 hours.

干预措施: Bioimpedance Analyser (Other)

pregnancy complication group

Maternal condition that could affect body fluid including:

  • Pre-eclampsia requiring hospital admission.
  • Hyperemesis gravidarum.
  • Major postpartum haemorrhage.

干预措施: Bioimpedance Analyser (Other)

control

Gestational age matched controls.

干预措施: Bioimpedance Analyser (Other)

结局指标

主要结局

Bioimpedance assessment of hydration status

时间窗: on admission

assessment of extracellular and intra-cellular body fluid using Bio-electrical impedance analysis and comparing results to standard fluid chart.

次要结局

未报告次要终点

研究者

发起方
University Hospitals, Leicester
申办方类型
Other
责任方
Sponsor

研究点 (1)

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