Hypertension in PregnancyNCT04303871
Invasive Versus Non-invasive Assessment of Blood Pressure in Hypertensive Disorders of Pregnancy
A study testing Invasive blood pressure assessment by radial artery canulation in people with Hypertension in Pregnancy, run by Assiut University at 1 site in Egypt.
Trial summary
Hypertensive disorders of pregnancy are important causes of maternal morbidity and mortality worldwide. Hypertension is one of the most commonly reported health conditions among pregnant women and complicates 5-10% of all pregnancies.(Martin et al., 2009) (Wagner et al., 2007) The measurement of central BP in… Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Hypertension in Pregnancy
- What is being tested?
- Invasive blood pressure assessment by radial artery canulation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 117 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2018to 5 Mar 2020
- 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 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- All Pregnant women diagnosed to have hypertensive disorders of pregnancy (chronic HTN, gestational HTN, pre-eclampsia or eclampsia) after control of hypertension using anti-hypertensive drugs.
Who cannot join
- Patients with previous cardiac diseases.
- Chronic kidney disease (CKD) which is defined as kidney damage or glomerular filtration rate (GFR) <60 mL/min/1.73 m2 for 3 months or more, irrespective of cause.
- Any disease requiring the use of anti-inflammatory medication, any other endocrine disease such as hyperthyroidism.
- Conditions that prevent invasive blood pressure measurement (arterial cannulation) as severe bleeding disorders.
- Patients refusing to join the study.
- Any associated severe comorbidities have been excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison Between Invasive and Non-invasive Assessment of Blood Pressure in Hypertensive Disorders of Pregnancy
Hypertensive disorders of pregnancy are important causes of maternal morbidity and mortality worldwide. Hypertension is one of the most commonly reported health conditions among pregnant women and complicates 5-10% of all pregnancies.(Martin et al., 2009) (Wagner et al., 2007) The measurement of central BP in hypertensive patients became more important because of its predictive value for cardiovascular events. Direct intra-arterial readings are considered to be the gold standard method for blood pressure measurement but because arterial cannulation is associated with risks, alternative non-invasive blood pressure measurements may be used. (Araghi et al., 2006) In our study, the investigator aimed to assess the accuracy of non-invasive central blood pressure by oscillometric automated device (Mobil O graph) in comparison to the invasive blood pressure measurement by arterial cannulation in patients with hypertensive disorders in pregnancy.
the investigators enrolled 100 pregnant women and 10 healthy non-pregnant women as a control group, central blood pressure was measured invasively by arterial cannula and non-invasively by oscillometric automated device (Mobil O Graph).
the investigatorshave found a high correlation between non-invasive central blood pressure measurements and invasively measured both systolic (r 0.968, p=0.000) and diastolic (r 0.687, p=0.000).
Read the detailed description
Study Methods:
All patients included in our study were subjected to the following:
- Full history taking including: Age, full obstetric history including (number of previous pregnancies and abortions), history of previous illness, duration of pregnancy. Risk factors for developing hypertension as Diabetes Mellitus (DM), history of chronic hypertension, anti-hypertensive treatment, history of HTN during previous pregnancies.
- Full physical examination: On admission: Patient's weight and height were obtained to calculate Body surface area (BSA) Vital signs assessment regarding arterial pulse, arterial blood pressure measurement using mercury sphygmomanometer and proper arm cuff according to the recent guidelines of arterial hypertension General and local cardiac examination.
- Investigations : the followings were done at time of hospital admission:
- Urine analysis: was done to all participants to exclude the presence of albuminuria
- Echocardiography:
All participants underwent resting transthoracic 2D echocardiography, Scans were acquired by a standard parasternal/apical views using (VIVID S5 instrument, GE Medical Systems, Horten, Norway) with subjects in the left lateral decubitus position.
- Blood pressure assessment: was done after control of blood pressure by different anti-hypertensive drugs mostly on 3rd- 4th day of admission.
- Office blood pressure measurement: BP in pregnancy was measured in the sitting position (or the left lateral recumbent during labour) with an appropriately sized arm cuff at heart level and using Korotkoff V for DBP. Manual auscultation was the only method used as it remains the gold standard for BP measurement in pregnancy, because automated devices tend to under-record the BP and are unreliable in severe preeclampsia.
- Non-invasive central BP monitoring: measured by MOBIL-O-GRAPH:
- The non-invasive assessment of estimated PWV was performed in a quiet, temperature-controlled examination room
- Three measurements were taken with a 2-min break between them. The procedure was performed with the patient in a sitting position and using an adequately sized cuff. The Mobil-O-Graph 24h NG (IEM, Stolberg, Germany) with inbuilt ARCSolver (Austrian Institute of Technology, Vienna, Austria) This device is a commercially available brachial oscillometric blood pressure monitor with Food and Drug Administration and Conformite´ Europe´enne approval. Its blood pressure detection unit is validated according to the British Hypertension Society and European Society of Hypertension recommendations. Algorithms were used to obtain conventional blood pressure readings such as brachial systolic and diastolic pressures. In the second step, the brachial cuff is inflated to the diastolic blood pressure level and held for about 10s to record the pulse waves. Subsequently, central pressure curves obtained through a transfer function from the peripheral reading are plotted. To estimate aPWV, the ARCSolver method utilizes several parameters from pulse wave analysis and wave separation analysis combined in a proprietary mathematical model, whereby the major determinants are age (Mendes, 2015) , central pressure, and aortic characteristic impedance.
- Invasive blood pressure measurement:
Cannulation technique:
Percutaneous cannulation is performed under aseptic conditions, using the radial artery. The hand and forearm are affixed to an arm board, with the wrist dorsiflexed over a bandage roll. The thumb should be immobilized as well, to ensure proper anchorage of the artery. the investigators infiltrate subcutaneously with 2% lidocaine as a local anaesthetic, it helps also to minimize arterial spasm.
Using palpation of the artery as a guide, the cannula (20-gauge Teflon cannula) is advanced at a 20° angle to the skin until the arterial wall is pierced. The stylet is then held fixed and the cannula advanced up the arterial lumen.
The cannula was connected to a disposable tubing system and flushed intermittently with heparinized 0.9% saline solution. This helped prevent occlusion of the cannula by thrombus .The tubing should be stiff and not contain any bubbles in order to minimize resonance and damping.
The liquid within the tubing was connected to a transducer (Auto Transducer®; ACE Medical, Inc., Goyang, Korea). The transducer needs to be kept horizontally level with the patient; traditionally, the right atrium because raising or lowering the transducer relative to the patient will alter the reading. Zeroing was performed by opening the transducer to atmospheric pressure and electronically zeroing the system.
The arterial blood pressure signals were recorded and displayed on a bedside monitor (GE Datex-Ohmeda S/5TM Anaesthesia Monitor, Helsinki, Finland).The whole tubing system was flushed with sterile normal saline to eliminate air bubbles and tested for system loss.
- Conditions
- Hypertension in Pregnancy
- Being tested
- Invasive blood pressure assessment by radial artery canulation
- Keywords
- invasive blood pressure, non-invasive blood pressure
- Medical subject headings
- Hypertension, Pregnancy-Induced
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Invasive blood pressure assessment by radial artery canulationDiagnostic test
Also called non invasive assement of BP by automated ossilometric M-Moblie graph
radial artery canula used to measure central blood pressure compared to non invasive automated device to measure BP in pregnant females
| Study group | Role | What they receive |
|---|---|---|
| patients | Active comparator | pregnant female with hypertension admitted in ICUfor control of BP invasive assessment of BP by radial cannulation was compared against non-invasive assessment of BP by an automated oscillometric BP device (Mobil-O-Graph ) Receives: Diagnostic Test: Invasive blood pressure assessment by radial artery canulation |
| control | Placebo comparator | matched control females of the same age but not pregnant invasive compared to non-invasive measurement of BP by same technique Receives: Diagnostic Test: Invasive blood pressure assessment by radial artery canulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
assess accuracy of non-invasive central blood pressure
to assess accuracy of non-invasive central blood pressure by oscillometric automated device (Mobil O graph) in comparison to the invasive blood pressure measurement by arterial cannulation in patients with hypertensive disorders in pregnancy
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2020
- Study start1 Dec 2018
- Primary completion1 Mar 2020
- Study completion5 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Hypertension in PregnancyStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 117 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayman Khairy Mohamed Hassan, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04303871
- Sponsor's protocol ID
- 17101032
- Status last verified
- Mar 2020
- First submitted
- 9 Mar 2020
- Last updated
- 12 Mar 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
KROEKER EJ, WOOD EH. Comparison of simultaneously recorded central and peripheral arterial pressure pulses during rest, exercise and tilted position in man. Circ Res. 1955 Nov;3(6):623-32. doi: 10.1161/01.res.3.6.623. No abstract available.
PubMed 13270378Hassan AKM, Shaamash AH, Mohamed AG, Demitry SR, Razik NA. Comparison between invasive and non-invasive assessment of blood pressure in hypertensive disorders of pregnancy. Egypt Heart J. 2021 May 25;73(1):48. doi: 10.1186/s43044-021-00172-7.
PubMed 34032932
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Invasive and Non-invasive Assessment of Blood Pressure in Hypertensive Disorders of Pregnancy
- ClinicalTrials.gov ID
- NCT04303871
- Acronym / sponsor ID
- 17101032
- Conditions
- Hypertension in Pregnancy
- Keywords
- invasive blood pressure, non-invasive blood pressure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 117 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Dec 2018 (actual)
- Primary completion
- 1 Mar 2020 (actual)
- Study completion
- 5 Mar 2020 (actual)
- First posted
- 11 Mar 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.
Hypertensive disorders of pregnancy are important causes of maternal morbidity and mortality worldwide. Hypertension is one of the most commonly reported health conditions among pregnant women and complicates 5-10% of all pregnancies.(Martin et al., 2009) (Wagner et al., 2007) The measurement of central BP in hypertensive patients became more important because of its predictive value for cardiovascular events. Direct intra-arterial readings are considered to be the gold standard method for blood pressure measurement but because arterial cannulation is associated with risks, alternative non-invasive blood pressure measurements may be used. (Araghi et al., 2006) In our study, the investigator aimed to assess the accuracy of non-invasive central blood pressure by oscillometric automated device (Mobil O graph) in comparison to the invasive blood pressure measurement by arterial cannulation in patients with hypertensive disorders in pregnancy.
the investigators enrolled 100 pregnant women and 10 healthy non-pregnant women as a control group, central blood pressure was measured invasively by arterial cannula and non-invasively by oscillometric automated device (Mobil O Graph).
the investigatorshave found a high correlation between non-invasive central blood pressure measurements and invasively measured both systolic (r 0.968, p=0.000) and diastolic (r 0.687, p=0.000).
Detailed description
Study Methods:
All patients included in our study were subjected to the following:
- Full history taking including: Age, full obstetric history including (number of previous pregnancies and abortions), history of previous illness, duration of pregnancy. Risk factors for developing hypertension as Diabetes Mellitus (DM), history of chronic hypertension, anti-hypertensive treatment, history of HTN during previous pregnancies.
- Full physical examination: On admission: Patient's weight and height were obtained to calculate Body surface area (BSA) Vital signs assessment regarding arterial pulse, arterial blood pressure measurement using mercury sphygmomanometer and proper arm cuff according to the recent guidelines of arterial hypertension General and local cardiac examination.
- Investigations : the followings were done at time of hospital admission:
- Urine analysis: was done to all participants to exclude the presence of albuminuria
- Echocardiography:
All participants underwent resting transthoracic 2D echocardiography, Scans were acquired by a standard parasternal/apical views using (VIVID S5 instrument, GE Medical Systems, Horten, Norway) with subjects in the left lateral decubitus position.
- Blood pressure assessment: was done after control of blood pressure by different anti-hypertensive drugs mostly on 3rd- 4th day of admission.
- Office blood pressure measurement: BP in pregnancy was measured in the sitting position (or the left lateral recumbent during labour) with an appropriately sized arm cuff at heart level and using Korotkoff V for DBP. Manual auscultation was the only method used as it remains the gold standard for BP measurement in pregnancy, because automated devices tend to under-record the BP and are unreliable in severe preeclampsia.
- Non-invasive central BP monitoring: measured by MOBIL-O-GRAPH:
- The non-invasive assessment of estimated PWV was performed in a quiet, temperature-controlled examination room
- Three measurements were taken with a 2-min break between them. The procedure was performed with the patient in a sitting position and using an adequately sized cuff. The Mobil-O-Graph 24h NG (IEM, Stolberg, Germany) with inbuilt ARCSolver (Austrian Institute of Technology, Vienna, Austria) This device is a commercially available brachial oscillometric blood pressure monitor with Food and Drug Administration and Conformite´ Europe´enne approval. Its blood pressure detection unit is validated according to the British Hypertension Society and European Society of Hypertension recommendations. Algorithms were used to obtain conventional blood pressure readings such as brachial systolic and diastolic pressures. In the second step, the brachial cuff is inflated to the diastolic blood pressure level and held for about 10s to record the pulse waves. Subsequently, central pressure curves obtained through a transfer function from the peripheral reading are plotted. To estimate aPWV, the ARCSolver method utilizes several parameters from pulse wave analysis and wave separation analysis combined in a proprietary mathematical model, whereby the major determinants are age (Mendes, 2015) , central pressure, and aortic characteristic impedance.
- Invasive blood pressure measurement:
Cannulation technique:
Percutaneous cannulation is performed under aseptic conditions, using the radial artery. The hand and forearm are affixed to an arm board, with the wrist dorsiflexed over a bandage roll. The thumb should be immobilized as well, to ensure proper anchorage of the artery. the investigators infiltrate subcutaneously with 2% lidocaine as a local anaesthetic, it helps also to minimize arterial spasm.
Using palpation of the artery as a guide, the cannula (20-gauge Teflon cannula) is advanced at a 20° angle to the skin until the arterial wall is pierced. The stylet is then held fixed and the cannula advanced up the arterial lumen.
The cannula was connected to a disposable tubing system and flushed intermittently with heparinized 0.9% saline solution. This helped prevent occlusion of the cannula by thrombus .The tubing should be stiff and not contain any bubbles in order to minimize resonance and damping.
The liquid within the tubing was connected to a transducer (Auto Transducer®; ACE Medical, Inc., Goyang, Korea). The transducer needs to be kept horizontally level with the patient; traditionally, the right atrium because raising or lowering the transducer relative to the patient will alter the reading. Zeroing was performed by opening the transducer to atmospheric pressure and electronically zeroing the system.
The arterial blood pressure signals were recorded and displayed on a bedside monitor (GE Datex-Ohmeda S/5TM Anaesthesia Monitor, Helsinki, Finland).The whole tubing system was flushed with sterile normal saline to eliminate air bubbles and tested for system loss.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients | Active comparator | Diagnostic Test: Invasive blood pressure assessment by radial artery canulationpregnant female with hypertension admitted in ICUfor control of BP invasive assessment of BP by radial cannulation was compared against non-invasive assessment of BP by an automated oscillometric BP device (Mobil-O-Graph ) |
| control | Placebo comparator | Diagnostic Test: Invasive blood pressure assessment by radial artery canulationmatched control females of the same age but not pregnant invasive compared to non-invasive measurement of BP by same technique |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- All Pregnant women diagnosed to have hypertensive disorders of pregnancy (chronic HTN, gestational HTN, pre-eclampsia or eclampsia) after control of hypertension using anti-hypertensive drugs.
Key exclusion criteria (6 listed)
- Patients with previous cardiac diseases.
- Chronic kidney disease (CKD) which is defined as kidney damage or glomerular filtration rate (GFR) <60 mL/min/1.73 m2 for 3 months or more, irrespective of cause.
- Any disease requiring the use of anti-inflammatory medication, any other endocrine disease such as hyperthyroidism.
- Conditions that prevent invasive blood pressure measurement (arterial cannulation) as severe bleeding disorders.
- Patients refusing to join the study.
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 |
|---|---|---|
| Invasive blood pressure assessment by radial artery canulationAlso: non invasive assement of BP by automated ossilometric M-Moblie graphradial artery canula used to measure central blood pressure compared to non invasive automated device to measure BP in pregnant females | Diagnostic test | control, patients |
Primary outcome
assess accuracy of non-invasive central blood pressure
Time frame: 12 months
to assess accuracy of non-invasive central blood pressure by oscillometric automated device (Mobil O graph) in comparison to the invasive blood pressure measurement by arterial cannulation in patients with hypertensive disorders in pregnancy
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 12 Mar 2020.
- Background: PubMed 13270378KROEKER EJ, WOOD EH. Comparison of simultaneously recorded central and peripheral arterial pressure pulses during rest, exercise and tilted position in man. Circ Res. 1955 Nov;3(6):623-32. doi: 10.1161/01.res.3.6.623. No abstract available.
- Derived from this study: PubMed 34032932Hassan AKM, Shaamash AH, Mohamed AG, Demitry SR, Razik NA. Comparison between invasive and non-invasive assessment of blood pressure in hypertensive disorders of pregnancy. Egypt Heart J. 2021 May 25;73(1):48. doi: 10.1186/s43044-021-00172-7.
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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 Invasive blood pressure assessment by radial artery canulation in people with Hypertension in Pregnancy, run by Assiut University at 1 site in Egypt.
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 1 inclusion and 6 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 12 Mar 2020. 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 Egypt. 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. Some participants in this study may receive a placebo. 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?
assess accuracy of non-invasive central blood pressure (time frame: 12 months). 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 NCT04303871, which also lists 2 linked publications.
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 12 Mar 2020.