Invasive Versus Non-invasive Assessment of Blood Pressure in Hypertensive Disorders of Pregnancy

NCT04303871 | Completed

• 1 other identifier: 17101032
• Study Type: interventional
• Target: 117
• Locations: 1 country
• Sites: 1

Brief 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 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).

Conditions

Hypertension in Pregnancy

Keywords

invasive blood pressure; non-invasive blood pressure

Outcome Measures

Primary Outcomes (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

  12 months

Study Arms (2)

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 )

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

Diagnostic Test: Invasive blood pressure assessment by radial artery canulation

Interventions

Invasive blood pressure assessment by radial artery canulation DIAGNOSTIC_TEST

radial artery canula used to measure central blood pressure compared to non invasive automated device to measure BP in pregnant females

Also known as: non invasive assement of BP by automated ossilometric M-Moblie graph

control; patients

Eligibility Criteria

• Age: 18 Years - 50 Years
• Gender Eligibility Details: only females included during pregnancy
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut University Hospitals

Asyut, 71526, Egypt

Location

Related Publications (2)

• 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.

  PMID: 13270378 BACKGROUND

• 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.

  PMID: 34032932 DERIVED

MeSH Terms

Conditions

Hypertension, Pregnancy-Induced

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant professor

Study Record Dates

• First Submitted: March 9, 2020
• First Posted: March 11, 2020
• Study Start: December 1, 2018
• Primary Completion: March 1, 2020
• Study Completion: March 5, 2020
• Last Updated: March 12, 2020

Record last verified: 2020-03

Locations

EG (1)