Skip to content

Does Prone Position Alter Maternal Cardiorespiratory Status?

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04586283
Enrollment
21
Registered
2020-10-14
Start date
2021-07-01
Completion date
2022-05-16
Last updated
2022-05-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pregnancy-Related Condition, Unspecified

Keywords

Maternal prone position, Cardiac output, Fetal heart rate, Cardiotocography, Maternal anxiety

Brief summary

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.

Detailed description

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.

Interventions

OTHERMaternal prone position

Women will be asked to lie in a prone position supported by a specially designed cushion for 30 minutes.

Sponsors

University of Manchester
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Masking description

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

Intervention model description

Cohort study

Eligibility

Sex/Gender
FEMALE
Age
16 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* 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

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Change in maternal cardiac outputAfter 30 minutes in prone positionMaternal 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.
Maternal cardiac output at BaselineAt baselineMaternal cardiac output as assessed by non-invasive cardiac monitoring.

Secondary

MeasureTime frameDescription
Change in maternal heart rateAfter 30 minutes in prone positionMaternal heart rate as assessed by non-invasive monitoring (as beats per minute) in prone position. Change calculated as Maternal heart rate after 30 minutes in prone position - baseline heart rate.
Maternal respiratory rateAt baselineMaternal respiratory rate as assessed by counting respirations (per minute)
Change in maternal respiratory rateAfter 30 minutes in prone positionMaternal respiratory rate as assessed by counting respirations (per minute) in prone position. Change calculated as Maternal respiratory rate after 30 minutes in prone position - baseline respiratory rate.
Maternal blood pressureAt baselineBoth maternal systolic and diastolic blood pressure as assessed noninvasive blood pressure monitoring
Maternal heart rate at baselineAt baselineMaternal heart rate as assessed by non-invasive monitoring (as beats per minute).
Change in oxygen saturationAfter 30 minutes in prone positionOxygen saturation measured by pulse oximetry in prone position. Change calculated as Maternal oxygen saturation after 30 minutes in prone position - baseline oxygen saturation.
Fetal heart rateBaselineFetal wellbeing assessed by continuous cardiotocography which will report baseline heart rate, variability, the presence of accelerations or decelerations.
Change in fetal heart rateAfer 30 minutes in prone positionFetal wellbeing assessed by continuous cardiotocography which will report baseline heart rate, variability, the presence of accelerations or decelerations.
Change in maternal blood pressureAfter 30 minutes in prone positionBoth maternal systolic and diastolic blood pressure as assessed noninvasive blood pressure monitoring in prone position. Change calculated as maternal systolic blood pressure after 30 minutes in prone position - baseline systolic blood pressure or maternal diastolic blood pressure after 30 minutes in prone position - baseline diastolic blood pressure.
Oxygen saturationAt baselineOxygen saturation measured by pulse oximetry

Other

MeasureTime frameDescription
Maternal AnxietyBefore the experimental protocolMaternal anxiety will be assessed using the State Trait Anxiety Index (scores range from 20-80, where higher scores indicate greater anxiety).
Maternal comfort as assessed by visual analogue scaleBefore the experimental protocolMaternal comfort as assesed by a visual analogue scale from 0-10. Higher scores indicate greater discomfort.
Maternal comfort as assessed by self-reported questionnaireImmediately after the completion of the experimental protocolMaternal comfort as assessed by self-reported questionnaire using Likert scales (from 1-5, where higher scores indicate greater agreement with the statement) and free-text responses

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 10, 2026