Does Prone Position Alter Maternal Cardiorespiratory Status?
Primary Purpose
Pregnancy-Related Condition, Unspecified
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Maternal prone position
Sponsored by
About this trial
This is an interventional treatment trial for Pregnancy-Related Condition, Unspecified focused on measuring Maternal prone position, Cardiac output, Fetal heart rate, Cardiotocography, Maternal anxiety
Eligibility Criteria
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
Sites / Locations
- Manchester University NHS Foundation Trust
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Maternal Prone Position
Arm Description
Participants will initially be assessed in left-lateral position for 20 minutes. Participants will then be asked to lie in a prone position for 30 minutes supported by a specially designed pillow. Participants will then return to a left-lateral position for 20 minutes.
Outcomes
Primary Outcome Measures
Maternal cardiac output at Baseline
Maternal cardiac output as assessed by non-invasive cardiac monitoring.
Change in maternal cardiac output
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.
Secondary Outcome Measures
Maternal heart rate at baseline
Maternal heart rate as assessed by non-invasive monitoring (as beats per minute).
Change in maternal heart rate
Maternal 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 rate
Maternal respiratory rate as assessed by counting respirations (per minute)
Change in maternal respiratory rate
Maternal 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 pressure
Both maternal systolic and diastolic blood pressure as assessed noninvasive blood pressure monitoring
Change in maternal blood pressure
Both 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 saturation
Oxygen saturation measured by pulse oximetry
Change in oxygen saturation
Oxygen 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 rate
Fetal wellbeing assessed by continuous cardiotocography which will report baseline heart rate, variability, the presence of accelerations or decelerations.
Change in fetal heart rate
Fetal wellbeing assessed by continuous cardiotocography which will report baseline heart rate, variability, the presence of accelerations or decelerations.
Full Information
NCT ID
NCT04586283
First Posted
September 22, 2020
Last Updated
May 16, 2022
Sponsor
University of Manchester
1. Study Identification
Unique Protocol Identification Number
NCT04586283
Brief Title
Does Prone Position Alter Maternal Cardiorespiratory Status?
Official Title
Does Maternal Prone Position Affect Maternal Cardiorespiratory Status or the Fetal Heart Rate?
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
July 1, 2021 (Actual)
Primary Completion Date
March 31, 2022 (Actual)
Study Completion Date
May 16, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Manchester
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pregnancy-Related Condition, Unspecified
Keywords
Maternal prone position, Cardiac output, Fetal heart rate, Cardiotocography, Maternal anxiety
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Cohort study
Masking
None (Open Label)
Masking Description
As the study involves examination of cardiorespiratory indices in different maternal positions investigators cannot be blind to the participants' position.
Allocation
N/A
Enrollment
21 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Maternal Prone Position
Arm Type
Experimental
Arm Description
Participants will initially be assessed in left-lateral position for 20 minutes. Participants will then be asked to lie in a prone position for 30 minutes supported by a specially designed pillow. Participants will then return to a left-lateral position for 20 minutes.
Intervention Type
Other
Intervention Name(s)
Maternal prone position
Intervention Description
Women will be asked to lie in a prone position supported by a specially designed cushion for 30 minutes.
Primary Outcome Measure Information:
Title
Maternal cardiac output at Baseline
Description
Maternal cardiac output as assessed by non-invasive cardiac monitoring.
Time Frame
At baseline
Title
Change in maternal cardiac output
Description
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.
Time Frame
After 30 minutes in prone position
Secondary Outcome Measure Information:
Title
Maternal heart rate at baseline
Description
Maternal heart rate as assessed by non-invasive monitoring (as beats per minute).
Time Frame
At baseline
Title
Change in maternal heart rate
Description
Maternal 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.
Time Frame
After 30 minutes in prone position
Title
Maternal respiratory rate
Description
Maternal respiratory rate as assessed by counting respirations (per minute)
Time Frame
At baseline
Title
Change in maternal respiratory rate
Description
Maternal 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.
Time Frame
After 30 minutes in prone position
Title
Maternal blood pressure
Description
Both maternal systolic and diastolic blood pressure as assessed noninvasive blood pressure monitoring
Time Frame
At baseline
Title
Change in maternal blood pressure
Description
Both 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.
Time Frame
After 30 minutes in prone position
Title
Oxygen saturation
Description
Oxygen saturation measured by pulse oximetry
Time Frame
At baseline
Title
Change in oxygen saturation
Description
Oxygen saturation measured by pulse oximetry in prone position. Change calculated as Maternal oxygen saturation after 30 minutes in prone position - baseline oxygen saturation.
Time Frame
After 30 minutes in prone position
Title
Fetal heart rate
Description
Fetal wellbeing assessed by continuous cardiotocography which will report baseline heart rate, variability, the presence of accelerations or decelerations.
Time Frame
Baseline
Title
Change in fetal heart rate
Description
Fetal wellbeing assessed by continuous cardiotocography which will report baseline heart rate, variability, the presence of accelerations or decelerations.
Time Frame
Afer 30 minutes in prone position
Other Pre-specified Outcome Measures:
Title
Maternal Anxiety
Description
Maternal anxiety will be assessed using the State Trait Anxiety Index (scores range from 20-80, where higher scores indicate greater anxiety).
Time Frame
Before the experimental protocol
Title
Maternal Anxiety
Description
Maternal anxiety will be assessed using the State Trait Anxiety Index (scores range from 20-80, where higher scores indicate greater anxiety).
Time Frame
Immediately after the completion of the experimental protocol
Title
Maternal comfort as assessed by visual analogue scale
Description
Maternal comfort as assesed by a visual analogue scale from 0-10. Higher scores indicate greater discomfort.
Time Frame
Before the experimental protocol
Title
Maternal comfort as assessed by visual analogue scale
Description
Maternal comfort as assesed by a visual analogue scale from 0-10. Higher scores indicate greater discomfort.
Time Frame
Immediately after the completion of the experimental protocol
Title
Maternal comfort as assessed by self-reported questionnaire
Description
Maternal 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
Time Frame
Immediately after the completion of the experimental protocol
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
Pregnant women
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Manchester University NHS Foundation Trust
City
Manchester
ZIP/Postal Code
M13 9WL
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
There is currently no plans to make individual participant data available to other researchers.
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Does Prone Position Alter Maternal Cardiorespiratory Status?
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