Pregnancy-Related Condition, UnspecifiedNCT04586283
Does Prone Position Alter Maternal Cardiorespiratory Status?
A study testing Maternal prone position in people with Pregnancy-Related Condition, Unspecified, run by University of Manchester at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy-Related Condition, Unspecified
- What is being tested?
- Maternal prone position
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Jul 2021to 16 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Manchester University NHS Foundation Trust
Manchester, M13 9WL
About this study
Official title: Does Maternal Prone Position Affect Maternal Cardiorespiratory Status or the Fetal Heart Rate?
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.
Read the 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.
- Conditions
- Pregnancy-Related Condition, Unspecified
- Being tested
- Maternal prone position
- Keywords
- Maternal prone position, Cardiac output, Fetal heart rate, Cardiotocography, Maternal anxiety
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Maternal prone positionOther
Women will be asked to lie in a prone position supported by a specially designed cushion for 30 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Maternal Prone Position | Experimental | 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. Receives: Other: Maternal prone position |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maternal cardiac output at Baseline
Maternal cardiac output as assessed by non-invasive cardiac monitoring.
Measured: At baseline
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.
Measured: After 30 minutes in prone position
Secondary outcomes (10)
Maternal heart rate at baseline
Maternal heart rate as assessed by non-invasive monitoring (as beats per minute).
Measured: At baseline
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.
Measured: After 30 minutes in prone position
Maternal respiratory rate
Maternal respiratory rate as assessed by counting respirations (per minute)
Measured: At baseline
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.
Measured: After 30 minutes in prone position
Maternal blood pressure
Both maternal systolic and diastolic blood pressure as assessed noninvasive blood pressure monitoring
Measured: At baseline
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.
Measured: After 30 minutes in prone position
Oxygen saturation
Oxygen saturation measured by pulse oximetry
Measured: At baseline
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.
Measured: After 30 minutes in prone position
Fetal heart rate
Fetal wellbeing assessed by continuous cardiotocography which will report baseline heart rate, variability, the presence of accelerations or decelerations.
Measured: Baseline
Change in fetal heart rate
Fetal wellbeing assessed by continuous cardiotocography which will report baseline heart rate, variability, the presence of accelerations or decelerations.
Measured: Afer 30 minutes in prone position
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2020
- Study start1 Jul 2021
- Primary completion31 Mar 2022
- Study completion16 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pregnancy-Related Condition, UnspecifiedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Cohort study
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Manchester
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Alexander Heazell, University of Manchester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04586283
- Sponsor's protocol ID
- IRAS240071
- Status last verified
- May 2022
- First submitted
- 22 Sep 2020
- Last updated
- 18 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is currently no plans to make individual participant data available to other researchers.
Publications
Ormesher L, Catchpole J, Peacock L, Pitt H, Fabian-Hunt A, Hayes D, Popp C, Carson JM, van Loon R, Warrander L, Buchling K, Heazell AEP. The effect of prone positioning on maternal haemodynamics and fetal wellbeing in the third trimester-A primary cohort study with a scoping review. PLoS One. 2023 Oct 11;18(10):e0287804. doi: 10.1371/journal.pone.0287804. eCollection 2023.
PubMed 37819872
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Maternal Prone Position Affect Maternal Cardiorespiratory Status or the Fetal Heart Rate?
- ClinicalTrials.gov ID
- NCT04586283
- Acronym / sponsor ID
- IRAS240071
- Conditions
- Pregnancy-Related Condition, Unspecified
- Keywords
- Maternal prone position, Cardiac output, Fetal heart rate, Cardiotocography, Maternal anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- University of ManchesterUniversity, hospital or other
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 31 Mar 2022 (actual)
- Study completion
- 16 May 2022 (actual)
- First posted
- 14 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Cohort study
| Arm | Type | Receives |
|---|---|---|
| Maternal Prone Position | Experimental | Other: Maternal prone positionParticipants 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. |
Who may qualify
- Ages
- 16 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Maternal prone positionWomen will be asked to lie in a prone position supported by a specially designed cushion for 30 minutes. | Other | Maternal Prone Position |
Primary outcome
Maternal cardiac output at Baseline
Time frame: At baseline
Maternal cardiac output as assessed by non-invasive cardiac monitoring.
Change in maternal cardiac output
Time frame: 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.
10 secondary outcomes
Maternal heart rate at baseline
Time frame: At baseline
Change in maternal heart rate
Time frame: After 30 minutes in prone position
Maternal respiratory rate
Time frame: At baseline
Change in maternal respiratory rate
Time frame: After 30 minutes in prone position
Maternal blood pressure
Time frame: At baseline
Change in maternal blood pressure
Time frame: After 30 minutes in prone position
Oxygen saturation
Time frame: At baseline
Change in oxygen saturation
Time frame: After 30 minutes in prone position
Fetal heart rate
Time frame: Baseline
Change in fetal heart rate
Time frame: Afer 30 minutes in prone position
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2022.
- Derived from this study: PubMed 37819872Ormesher L, Catchpole J, Peacock L, Pitt H, Fabian-Hunt A, Hayes D, Popp C, Carson JM, van Loon R, Warrander L, Buchling K, Heazell AEP. The effect of prone positioning on maternal haemodynamics and fetal wellbeing in the third trimester-A primary cohort study with a scoping review. PLoS One. 2023 Oct 11;18(10):e0287804. doi: 10.1371/journal.pone.0287804. eCollection 2023.
- Individual participant dataSharing planned: No. There is currently no plans to make individual participant data available to other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Maternal prone position in people with Pregnancy-Related Condition, Unspecified, run by University of Manchester at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maternal cardiac output at Baseline (time frame: At baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04586283, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2022.