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临床试验/NCT04586283
NCT04586283已完成不适用

Does Maternal Prone Position Affect Maternal Cardiorespiratory Status or the Fetal Heart Rate?

University of Manchester2 个研究点 分布在 1 个国家目标入组 21 人开始时间: 2021年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
21
试验地点
2
主要终点
Maternal cardiac output at Baseline

研究概览

简要总结

During pregnancy women may need or choose to undergo physical therapies such as physiotherapy, massage or osteopathy. Recent findings from studies of mothers who had a stillbirth in late pregnancy found that the position in which women went to sleep in was linked to stillbirth, as was the frequency of day time naps. This link is thought to be due to changes in mother's blood flow from her heart when lying flat leading to changes in the amount of oxygen going to her baby. This raise concerns that spending extended periods laid flat could be detrimental to baby's health. However, it is not known whether lying flat for extended periods for physical therapies could also alter a baby's heart rate or levels of oxygen. One small study of 33 women from Brazil found that there were no differences in a mother's heart rate, blood pressure, oxygen saturation or baby's heart rate. But there were changes in mother's breathing rate and systolic blood pressure when a mother laid on her front. All the women reported feeling comfortable lying flat (on a bent surface). However, in this study women only spent 6 minutes in each position which is less than a woman would be expected to spend lying in a position for a session of physical therapy. The investigators plan a study to assess whether using a device to support a prone position (Anna cushion) would be associated with changes in mother's heart rate, blood pressure, breathing rate and blood oxygen levels and baby's heart rate. The investigators will also ask about mother's levels of comfort while she is laid in the prone position. The findings of this study will give an indication whether supporting a mother to lie in a prone position for physical therapies is safe and comfortable.

详细描述

Women frequently experience lower-back or pelvic pain during pregnancy. This may lead to a need for physical therapies such as physiotherapy, osteopathy or massage in late pregnancy. Several case-control studies, and a recent individual patient data meta-analysis has demonstrated an association between going to sleep position and late stillbirth (a greater than 2-fold increased risk with going to sleep supine) and increased frequency of daytime naps. This is thought to be related to maternal haemodynamic changes when a mother lies supine in late pregnancy which decreases cardiac output and uterine blood flow. These changes are accompanied by alterations in fetal behaviour which are consistent with a reduction in oxygenation. This observation raises concerns that spending extended periods laid flat could be detrimental to baby's health. However, it is not known whether lying flat for extended periods for physical therapies could also alter a baby's heart rate or levels of oxygen. One small study of 33 women from Brazil which randomised the order of maternal positions found that there were no differences in a mother's heart rate, blood pressure, oxygen saturation or baby's heart rate between a supine, lateral and prone position (bent over a concave couch). However, there were observed changes in mother's breathing rate and systolic blood pressure when a mother laid on her front. Nevertheless, all the women reported feeling comfortable lying flat (on a bent surface). However, in this study women only spent 6 minutes in each position which is less than a woman would be expected to spend lying in a position for a session of physical therapy. Therefore, further work is required to determine whether spending extended periods laid prone is safe for mother and baby.

The co-investigator (Karli Büchling) has developed a cushion to support mothers in a prone position (Anna cushion). This study will investigate whether adopting this position supported by the cushion is associated with changes in mother's heart rate, blood pressure, breathing rate and blood oxygen levels and fetal heart rate as assessed by the cardiotocograph. The investigators will also ask about mother's levels of comfort while she is laid flat. The findings of this study will give an indication whether supporting a mother to lie in a prone position for physical therapies is safe and comfortable.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

盲法说明

As the study involves examination of cardiorespiratory indices in different maternal positions investigators cannot be blind to the participants' position.

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

  • Viable singleton pregnancy ≥28 weeks' gestation
  • No fetal anomalies according to Fetal Anomaly Screening Programme definition
  • Ability to give written informed consent
  • Maternal Age >16 years

排除标准

  • Unable to read English (as the survey instruments are only available in English)
  • Multiple pregnancy
  • Pre-existing maternal cardiovascular or respiratory disease
  • Fetal anomaly
  • Contraindication to lying prone (severe pain etc.)
  • Allergy to self-adhesive electrodes used for standard electrocardiography (ECG)
  • Unable to give written informed consent

结局指标

主要结局

Maternal cardiac output at Baseline

时间窗: At baseline

Maternal cardiac output as assessed by non-invasive cardiac monitoring.

Change in maternal cardiac output

时间窗: After 30 minutes in prone position

Maternal cardiac output as assessed by non-invasive cardiac monitoring in prone position. Change calculated as Maternal cardiac output after 30 minutes in prone position - baseline cardiac output.

次要结局

  • Maternal respiratory rate(At baseline)
  • Maternal heart rate at baseline(At baseline)
  • Change in maternal heart rate(After 30 minutes in prone position)
  • Maternal blood pressure(At baseline)
  • Change in maternal blood pressure(After 30 minutes in prone position)
  • Change in oxygen saturation(After 30 minutes in prone position)
  • Change in maternal respiratory rate(After 30 minutes in prone position)
  • Oxygen saturation(At baseline)
  • Fetal heart rate(Baseline)
  • Change in fetal heart rate(Afer 30 minutes in prone position)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr Alexander Heazell

Professor of Obstetrics

University of Manchester

研究点 (2)

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