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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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.

Egypt1 site
  • Assiut University Hospitals

    Asyut, 71526

Other trials in Egypt

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:

  1. 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.
  2. 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.
  3. Investigations : the followings were done at time of hospital admission:
  4. Urine analysis: was done to all participants to exclude the presence of albuminuria
  5. 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.

  1. Blood pressure assessment: was done after control of blood pressure by different anti-hypertensive drugs mostly on 3rd- 4th day of admission.
  2. 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.
  3. 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.
  1. 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.

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 groups in NCT04303871
Study groupRoleWhat they receive
patientsActive comparatorpregnant 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
controlPlacebo comparatormatched 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.

  1. 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.

  1. First posted11 Mar 2020
  2. Study start1 Dec 2018
  3. Primary completion1 Mar 2020
  4. Study completion5 Mar 2020

Resources

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)
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 13270378
  • Hassan 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

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.

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