Conical Forearm and Cylindrical Upper Arm Non-Invasive Blood Pressure (NIBP) Measurements in Pregnant Patients

NCT06466161 | Recruiting FDA Device

• 1 other identifier: STU00221793
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

The diagnosis of hypertensive disease during pregnancy is predicated on strict blood pressure thresholds: 140/90 on at least two occasions measured four hours apart for both gestational hypertension and preeclampsia. An improvement in diagnostic accuracy of even 5mm Hg would be significant, as reflected by the US Association for the Advancement of Medical Instrumentation (AAMI), the British Hypertension Society, the European Society of Hypertension (ESH) Working Group on Blood Pressure (BP) Monitoring, and the International Organization for Standardization (ISO)consensus for validation of non-invasive blood pressure (NIBP) devices during pregnancy. Given the known inaccuracies of upper arm cylindrical cuff measurements in morbidly obese patients, a conical cuff which provides more accurate measurements will translate into direct patient benefit via more informed diagnosis and management. Fewer women may be exposed to unnecessary treatment, preterm delivery, and/or cesarean section. Recognizing the increasing prevalence of morbid obesity and hypertensive disease amongst pregnant women in the United States, the identification of a more accurate non-invasive cuff is desperately needed. Increasing the accuracy of NIBP measurements on Labor and Delivery has the potential to directly impact the management of tens of thousands of morbidly obese pregnant women diagnosed with hypertensive disease in the United States every year. Establishing the level of agreement between conical forearm and cylindrical upper arm cuffs will shed light on the presence and magnitude of any disparity between measurement methods. STUDY ENDPOINTS: Primary Outcome Measures:

• Agreement between conical and cylindrical cuff systolic blood pressure across groups
• Agreement between conical and cylindrical cuff diastolic blood pressure across groups Secondary Outcome Measures:
• Agreement between conical and cylindrical cuff mean arterial pressure

Conditions

Hypertension in Pregnancy; Hypertension; Obesity

Keywords

Hypertension; Conical Blood Pressure Cuff; Cylindrical Blood Pressure Cuff; Pregnancy; Obesity; Non invasive blood pressure

Outcome Measures

Primary Outcomes (2)

• Agreement between conical and cylindrical cuff systolic blood pressure as measured by mean absolute deviance

  Agreement between conical and cylindrical cuff systolic blood pressure across 4 distinct subject groups:(1) normotensive/non-obese (2) normotensive/obese (3) hypertensive/non-obese and (4) hypertensive/obese.

  Through study completion, an average of 1 year

• Agreement between conical and cylindrical cuff diastolic blood pressure as measured by mean absolute deviance

  Agreement between conical and cylindrical cuff diastolic blood pressure across 4 distinct groups: (1) normotensive/non-obese (2) normotensive/obese (3) hypertensive/non-obese and (4) hypertensive/obese.

  Through study completion, an average of 1 year

Secondary Outcomes (2)

• Agreement between conical and cylindrical cuff mean arterial pressure as measured by mean absolute deviance

  Through study completion, an average of 1 year

• Likert scale patient satisfaction scores for conical and cylindrical cuff measurements

  Through study completion, an average of 1 year

Study Arms (2)

Group 1 Upper arm cylindrical cuff

ACTIVE COMPARATOR

In Group 1 the upper arm cylindrical cuff is inflated first and the blood pressure is measured. After one minute has elapsed, the forearm conical cuff is inflated and blood pressure measured.

Device: Upper Arm Cylindrical Blood Pressure Cuff

Group 2 Forearm conical cuff

EXPERIMENTAL

In Group 2 the forearm conical cuff is inflated first and the blood pressure is measured. After one minute has elapsed, the upper arm cylindrical cuff is inflated and blood pressure measured.

Device: Forearm Conical Blood Pressure Cuff

Interventions

Upper Arm Cylindrical Blood Pressure Cuff DEVICE

In Group 1, the upper arm cylindrical cuff is inflated first, followed by inflation of the forearm conical cuff.

Also known as: Upper Arm Cylindrical Blood Pressure Cuff Inflated First

Group 1 Upper arm cylindrical cuff

Forearm Conical Blood Pressure Cuff DEVICE

In Group 2, the forearm conical cuff is inflated first, followed by inflation of the upper arm cylindrical cuff.

Also known as: Forearm Conical Blood Pressure Cuff Inflated First

Group 2 Forearm conical cuff

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Women 18 years and older who are pregnant
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women who are 18 years of age or older with a
• Body mass index (BMI) of 20 kg/m2 or greater
• Present to Labor and Delivery with or without a diagnosis of gestational hypertension, preeclampsia, or chronic hypertension with super-imposed preeclampsia, in spontaneous labor or for induction of labor

You may not qualify if:

• Significant peripheral arterial disease resulting in at least a 10 mm Hg blood pressure difference between both arms
• History of repaired or unrepaired congenital heart disease
• History of significant arrythmia
• History of pacemaker or implantable cardioverter defibrillator placement
• History of sickle cell disease
• History of Raynaud's phenomenon on any extremity
• History of lymph node dissection of either upper extremity
• Patients who are less than 18 years of age

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (1)

Prentice Women's Hospital

Chicago, Illinois, 60611, United States

RECRUITING

Related Publications (24)

• American College of Obstetricians and Gynecologists. ACOG Committee opinion no. 549: obesity in pregnancy. Obstet Gynecol. 2013 Jan;121(1):213-7. doi: 10.1097/01.aog.0000425667.10377.60.

  PMID: 23262963 BACKGROUND

• Crane JM, Murphy P, Burrage L, Hutchens D. Maternal and perinatal outcomes of extreme obesity in pregnancy. J Obstet Gynaecol Can. 2013 Jul;35(7):606-611. doi: 10.1016/S1701-2163(15)30879-3.

  PMID: 23876637 BACKGROUND

• Chu SY, Kim SY, Lau J, Schmid CH, Dietz PM, Callaghan WM, Curtis KM. Maternal obesity and risk of stillbirth: a metaanalysis. Am J Obstet Gynecol. 2007 Sep;197(3):223-8. doi: 10.1016/j.ajog.2007.03.027.

  PMID: 17826400 BACKGROUND

• Lutsiv O, Mah J, Beyene J, McDonald SD. The effects of morbid obesity on maternal and neonatal health outcomes: a systematic review and meta-analyses. Obes Rev. 2015 Jul;16(7):531-46. doi: 10.1111/obr.12283. Epub 2015 Apr 24.

  PMID: 25912896 BACKGROUND

• Bicocca MJ, Mendez-Figueroa H, Chauhan SP, Sibai BM. Maternal Obesity and the Risk of Early-Onset and Late-Onset Hypertensive Disorders of Pregnancy. Obstet Gynecol. 2020 Jul;136(1):118-127. doi: 10.1097/AOG.0000000000003901.

  PMID: 32541276 BACKGROUND

• Bodnar LM, Catov JM, Klebanoff MA, Ness RB, Roberts JM. Prepregnancy body mass index and the occurrence of severe hypertensive disorders of pregnancy. Epidemiology. 2007 Mar;18(2):234-9. doi: 10.1097/01.ede.0000254119.99660.e7.

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• O'Brien TE, Ray JG, Chan WS. Maternal body mass index and the risk of preeclampsia: a systematic overview. Epidemiology. 2003 May;14(3):368-74. doi: 10.1097/00001648-200305000-00020.

  PMID: 12859040 BACKGROUND

• Lisonkova S, Joseph KS. Incidence of preeclampsia: risk factors and outcomes associated with early- versus late-onset disease. Am J Obstet Gynecol. 2013 Dec;209(6):544.e1-544.e12. doi: 10.1016/j.ajog.2013.08.019. Epub 2013 Aug 22.

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• Lisonkova S, Sabr Y, Mayer C, Young C, Skoll A, Joseph KS. Maternal morbidity associated with early-onset and late-onset preeclampsia. Obstet Gynecol. 2014 Oct;124(4):771-781. doi: 10.1097/AOG.0000000000000472.

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• ACOG Practice Bulletin No. 202: Gestational Hypertension and Preeclampsia. Obstet Gynecol. 2019 Jan;133(1):1. doi: 10.1097/AOG.0000000000003018.

  PMID: 30575675 BACKGROUND

• Creanga AA, Syverson C, Seed K, Callaghan WM. Pregnancy-Related Mortality in the United States, 2011-2013. Obstet Gynecol. 2017 Aug;130(2):366-373. doi: 10.1097/AOG.0000000000002114.

  PMID: 28697109 BACKGROUND

• Cantwell R, Clutton-Brock T, Cooper G, Dawson A, Drife J, Garrod D, Harper A, Hulbert D, Lucas S, McClure J, Millward-Sadler H, Neilson J, Nelson-Piercy C, Norman J, O'Herlihy C, Oates M, Shakespeare J, de Swiet M, Williamson C, Beale V, Knight M, Lennox C, Miller A, Parmar D, Rogers J, Springett A. Saving Mothers' Lives: Reviewing maternal deaths to make motherhood safer: 2006-2008. The Eighth Report of the Confidential Enquiries into Maternal Deaths in the United Kingdom. BJOG. 2011 Mar;118(Suppl 1):1-203. doi: 10.1111/j.1471-0528.2010.02847.x.

  PMID: 21356004 BACKGROUND

• Babbs CF. Oscillometric measurement of systolic and diastolic blood pressures validated in a physiologic mathematical model. Biomed Eng Online. 2012 Aug 22;11:56. doi: 10.1186/1475-925X-11-56.

  PMID: 22913792 BACKGROUND

• Mauck GW, Smith CR, Geddes LA, Bourland JD. The meaning of the point of maximum oscillations in cuff pressure in the indirect measurement of blood pressure--part ii. J Biomech Eng. 1980 Feb;102(1):28-33. doi: 10.1115/1.3138195.

  PMID: 7382450 BACKGROUND

• Palatini P, Benetti E, Fania C, Malipiero G, Saladini F. Rectangular cuffs may overestimate blood pressure in individuals with large conical arms. J Hypertens. 2012 Mar;30(3):530-6. doi: 10.1097/HJH.0b013e32834f98a0.

  PMID: 22278143 BACKGROUND

• Palatini P, Parati G. Blood pressure measurement in very obese patients: a challenging problem. J Hypertens. 2011 Mar;29(3):425-9. doi: 10.1097/HJH.0b013e3283435b65. No abstract available.

  PMID: 21317721 BACKGROUND

• Kho CL, Brown MA, Ong SL, Mangos GJ. Blood pressure measurement in pregnancy: the effect of arm circumference and sphygmomanometer cuff size. Obstet Med. 2009 Sep;2(3):116-20. doi: 10.1258/om.2009.090017. Epub 2009 Sep 1.

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• Schoenfeld A, Ziv I, Tzeel A, Ovadia J. Roll-over test--errors in interpretation, due to inaccurate blood pressure measurements. Eur J Obstet Gynecol Reprod Biol. 1985 Jan;19(1):23-30. doi: 10.1016/0028-2243(85)90161-3.

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• Stergiou GS, Alpert B, Mieke S, Asmar R, Atkins N, Eckert S, Frick G, Friedman B, Grassl T, Ichikawa T, Ioannidis JP, Lacy P, McManus R, Murray A, Myers M, Palatini P, Parati G, Quinn D, Sarkis J, Shennan A, Usuda T, Wang J, Wu CO, O'Brien E. A Universal Standard for the Validation of Blood Pressure Measuring Devices: Association for the Advancement of Medical Instrumentation/European Society of Hypertension/International Organization for Standardization (AAMI/ESH/ISO) Collaboration Statement. Hypertension. 2018 Mar;71(3):368-374. doi: 10.1161/HYPERTENSIONAHA.117.10237. Epub 2018 Jan 31.

  PMID: 29386350 BACKGROUND

• Palatini P, Asmar R. Cuff challenges in blood pressure measurement. J Clin Hypertens (Greenwich). 2018 Jul;20(7):1100-1103. doi: 10.1111/jch.13301.

  PMID: 30003699 BACKGROUND

• Leblanc ME, Croteau S, Ferland A, Bussieres J, Cloutier L, Hould FS, Biertho L, Moustarah F, Marceau S, Poirier P. Blood pressure assessment in severe obesity: validation of a forearm approach. Obesity (Silver Spring). 2013 Dec;21(12):E533-41. doi: 10.1002/oby.20458. Epub 2013 Jun 22.

  PMID: 23512945 BACKGROUND

• Leblanc ME, Auclair A, Leclerc J, Bussieres J, Agharazii M, Hould FS, Marceau S, Brassard P, Godbout C, Grenier A, Cloutier L, Poirier P. Blood Pressure Measurement in Severely Obese Patients: Validation of the Forearm Approach in Different Arm Positions. Am J Hypertens. 2019 Jan 15;32(2):175-185. doi: 10.1093/ajh/hpy152.

  PMID: 30312368 BACKGROUND

• Hersh LT, Sesing JC, Luczyk WJ, Friedman BA, Zhou S, Batchelder PB. Validation of a conical cuff on the forearm for estimating radial artery blood pressure. Blood Press Monit. 2014 Feb;19(1):38-45. doi: 10.1097/MBP.0000000000000011.

  PMID: 24217368 BACKGROUND

• Palatini P, Benetti E, Fania C, Saladini F. Only troncoconical cuffs can provide accurate blood pressure measurements in people with severe obesity. J Hypertens. 2019 Jan;37(1):37-41. doi: 10.1097/HJH.0000000000001823.

  PMID: 29927843 BACKGROUND

MeSH Terms

Conditions

Hypertension, Pregnancy-Induced; Hypertension; Obesity

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Vascular Diseases; Cardiovascular Diseases; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Adithya Bhat, MD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Adithya Bhat, MD

CONTACT

312-472-3585; adithya.bhat@northwestern.edu

Paul Fitzgerald, RN,BSN,MS

CONTACT

312-695-1064; p-fitzgerald2@northwestern.edu

Study Design

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

Model Details: Randomized, non blinded trial

Study Record Dates

• First Submitted: May 31, 2024
• First Posted: June 20, 2024
• Study Start: April 29, 2025
• Primary Completion (Estimated): July 30, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: April 13, 2026

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)