- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04586283
Does Prone Position Alter Maternal Cardiorespiratory Status?
Does Maternal Prone Position Affect Maternal Cardiorespiratory Status or the Fetal Heart Rate?
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Manchester, United Kingdom, M13 9WL
- Manchester University NHS Foundation Trust
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Maternal Prone Position
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.
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Women will be asked to lie in a prone position supported by a specially designed cushion for 30 minutes.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Maternal cardiac output at Baseline
Time Frame: At baseline
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Maternal cardiac output as assessed by non-invasive cardiac monitoring.
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At baseline
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Change in maternal cardiac output
Time Frame: After 30 minutes in prone position
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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.
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After 30 minutes in prone position
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Maternal heart rate at baseline
Time Frame: At baseline
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Maternal heart rate as assessed by non-invasive monitoring (as beats per minute).
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At baseline
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Change in maternal heart rate
Time Frame: After 30 minutes in prone position
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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.
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After 30 minutes in prone position
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Maternal respiratory rate
Time Frame: At baseline
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Maternal respiratory rate as assessed by counting respirations (per minute)
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At baseline
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Change in maternal respiratory rate
Time Frame: After 30 minutes in prone position
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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.
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After 30 minutes in prone position
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Maternal blood pressure
Time Frame: At baseline
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Both maternal systolic and diastolic blood pressure as assessed noninvasive blood pressure monitoring
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At baseline
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Change in maternal blood pressure
Time Frame: After 30 minutes in prone position
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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.
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After 30 minutes in prone position
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Oxygen saturation
Time Frame: At baseline
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Oxygen saturation measured by pulse oximetry
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At baseline
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Change in oxygen saturation
Time Frame: After 30 minutes in prone position
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Oxygen saturation measured by pulse oximetry in prone position.
Change calculated as Maternal oxygen saturation after 30 minutes in prone position - baseline oxygen saturation.
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After 30 minutes in prone position
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Fetal heart rate
Time Frame: Baseline
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Fetal wellbeing assessed by continuous cardiotocography which will report baseline heart rate, variability, the presence of accelerations or decelerations.
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Baseline
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Change in fetal heart rate
Time Frame: Afer 30 minutes in prone position
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Fetal wellbeing assessed by continuous cardiotocography which will report baseline heart rate, variability, the presence of accelerations or decelerations.
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Afer 30 minutes in prone position
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Maternal Anxiety
Time Frame: Before the experimental protocol
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Maternal anxiety will be assessed using the State Trait Anxiety Index (scores range from 20-80, where higher scores indicate greater anxiety).
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Before the experimental protocol
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Maternal Anxiety
Time Frame: Immediately after the completion of the experimental protocol
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Maternal anxiety will be assessed using the State Trait Anxiety Index (scores range from 20-80, where higher scores indicate greater anxiety).
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Immediately after the completion of the experimental protocol
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Maternal comfort as assessed by visual analogue scale
Time Frame: Before the experimental protocol
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Maternal comfort as assesed by a visual analogue scale from 0-10.
Higher scores indicate greater discomfort.
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Before the experimental protocol
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Maternal comfort as assessed by visual analogue scale
Time Frame: Immediately after the completion of the experimental protocol
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Maternal comfort as assesed by a visual analogue scale from 0-10.
Higher scores indicate greater discomfort.
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Immediately after the completion of the experimental protocol
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Maternal comfort as assessed by self-reported questionnaire
Time Frame: Immediately after the completion of the experimental protocol
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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
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Immediately after the completion of the experimental protocol
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRAS240071
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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