Hypertension in PregnancyNCT06466161
Conical Forearm and Cylindrical Upper Arm Non-Invasive Blood Pressure (NIBP) Measurements in Pregnant Patients
A study testing Upper Arm Cylindrical Blood Pressure Cuff and Forearm Conical Blood Pressure Cuff in people with Hypertension in Pregnancy and Hypertension, run by Northwestern University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Hypertension in Pregnancy, Hypertension, Obesity
- What is being tested?
- Upper Arm Cylindrical Blood Pressure Cuff and Forearm Conical Blood Pressure Cuff
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Apr 2025to 1 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Prentice Women's Hospital
Chicago, Illinois, 60611
Paul Fitzgerald, RN,BSN,MS, 312-926-1064, p-fitzgerald2@northwestern.edu
Adithya Bhat, MD
About this study
Official title: Evaluation of the Agreement Between Conical Forearm and Cylindrical Upper Arm Non-Invasive Blood Pressure (NIBP) Measurements in Pregnant Patients
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:
Read more
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
Read the detailed description
After participants have provided written informed consent they will be enrolled into one of four groups: (1) normotensive/non-obese (2) normotensive/obese (3) hypertensive/non-obese and (4) hypertensive/obese. The threshold for hypertension will be a BP measurement greater than 140/90 mmHg on two occasions at least 4 hours apart. After informed consent has been obtained, body weight (kg) and height (cm) will be measured on calibrated scales and BMI calculated. Arm circumference will be measured proximally just beneath the axilla, at mid- point between the acromion and the olecranon, and distally just above the antecubital fossa in centimeters. Forearm circumference will be measured, in millimeters, proximally just beneath the olecranon, at mid-point between the olecranon and the styloid apophysis, and distally just above the styloid apophysis. Upper arm length will be measured from the acromion to the olecranon in centimeters. Forearm length will be measured from the olecranon to the styloid apophysis in centimeters. Upper arm cuffs will be placed at the mid-point between the acromion and the olecranon processes. All BP measurements will be obtained from the participants while in the sitting position, and the arm contralateral to the peripheral intravenous catheter (PIV) will be chosen for measurement. If the PIV has not yet been placed, the arm selection will be made by the patient. Baseline BP measurement will be performed at the upper arm after at least a 5-minute resting period utilizing a large-sized cylindrical cuff. Baseline BP measurement at the forearm will be performed using a conical forearm cuff previously validated in non-pregnant patients with arm circumferences greater than or equal to 40 cm23 (RADIAL-CUF, GE HealthCare, Milwaukee, Wisconsin). The forearm cuff will be placed 3 cm from the styloid process of the ulna palpable at the wrist.
After two minutes have elapsed since the baseline measurements, sequential, paired BP measurements will then be obtained by cycling either the upper arm cylindrical cuff or forearm conical cuff, waiting 60 seconds after the measurement, then cycling the other cuff. The choice of cuff to be cycled first (conical or cylindrical) will be block randomized. Additional sequential measurements will then be obtained 2, 4, 6, 8, and 10 minutes after the first set. After the initial measurements, the upper arm cuff will automatically cycle every 15 minutes. Thus, all patients will have six sets of sequential BP measurements. Any decision to initiate antihypertensive therapy will be made by the patient's obstetrical provider, using an institutional algorithm and with reference to cylindrical cuff pressures.
- Conditions
- Hypertension in Pregnancy, Hypertension, Obesity
- Being tested
- Upper Arm Cylindrical Blood Pressure Cuff, Forearm Conical Blood Pressure Cuff
- Keywords
- Hypertension, Conical Blood Pressure Cuff, Cylindrical Blood Pressure Cuff, Pregnancy, Obesity, Non invasive blood pressure
- Medical subject headings
- Hypertension, Pregnancy-Induced, Hypertension, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Upper Arm Cylindrical Blood Pressure CuffDevice
Also called Upper Arm Cylindrical Blood Pressure Cuff Inflated First
In Group 1, the upper arm cylindrical cuff is inflated first, followed by inflation of the forearm conical cuff.
Forearm Conical Blood Pressure CuffDevice
Also called Forearm Conical Blood Pressure Cuff Inflated First
In Group 2, the forearm conical cuff is inflated first, followed by inflation of the upper arm cylindrical cuff.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Forearm Conical Blood Pressure Cuff |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
Agreement between conical and cylindrical cuff MAP arterial pressure among the 4 distinct groups:(1) normotensive/non-obese (2) normotensive/obese (3) hypertensive/non-obese and (4) hypertensive/obese.
Measured: Through study completion, an average of 1 year
Likert scale patient satisfaction scores for conical and cylindrical cuff measurements
Patient satisfaction scores for conical and cylindrical cuff measurements will be measured with a 5-question survey using 5-point scale, ranging from 0 (very painful/very dissatisfied) to 5 (not painful at all/very satisfied).
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2024
- Study start29 Apr 2025
- Primary completion30 Jul 2027 (estimated)
- Study completion1 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (24)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 Northwestern 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, non blinded trial
- Masking
- None (open label)
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adithya Bhat, Northwestern University
- Investigators
- Adithya Bhat, MD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06466161
- Sponsor's protocol ID
- STU00221793
- Status last verified
- Apr 2026
- First submitted
- 31 May 2024
- Last updated
- 26 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 23262963Crane 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.
PubMed 23876637Chu 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.
PubMed 17826400Lutsiv 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.
PubMed 25912896Bicocca 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.
PubMed 32541276Bodnar 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.
PubMed 17237733O'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.
PubMed 12859040Lisonkova 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.
PubMed 23973398Lisonkova 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.
PubMed 25198279ACOG Practice Bulletin No. 202: Gestational Hypertension and Preeclampsia. Obstet Gynecol. 2019 Jan;133(1):1. doi: 10.1097/AOG.0000000000003018.
PubMed 30575675Creanga 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.
PubMed 28697109Cantwell 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.
PubMed 21356004Babbs 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.
PubMed 22913792Mauck 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.
PubMed 7382450Palatini 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.
PubMed 22278143
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Agreement Between Conical Forearm and Cylindrical Upper Arm Non-Invasive Blood Pressure (NIBP) Measurements in Pregnant Patients
- ClinicalTrials.gov ID
- NCT06466161
- Acronym / sponsor ID
- STU00221793
- Conditions
- Hypertension in Pregnancy, Hypertension, Obesity
- Keywords
- Hypertension, Conical Blood Pressure Cuff, Cylindrical Blood Pressure Cuff, Pregnancy, Obesity, Non invasive blood pressure
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- 29 Apr 2025 (actual)
- Primary completion
- 30 Jul 2027 (estimated)
- Study completion
- 1 Sep 2027 (estimated)
- First posted
- 20 Jun 2024 (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.
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
Detailed description
After participants have provided written informed consent they will be enrolled into one of four groups: (1) normotensive/non-obese (2) normotensive/obese (3) hypertensive/non-obese and (4) hypertensive/obese. The threshold for hypertension will be a BP measurement greater than 140/90 mmHg on two occasions at least 4 hours apart. After informed consent has been obtained, body weight (kg) and height (cm) will be measured on calibrated scales and BMI calculated. Arm circumference will be measured proximally just beneath the axilla, at mid- point between the acromion and the olecranon, and distally just above the antecubital fossa in centimeters. Forearm circumference will be measured, in millimeters, proximally just beneath the olecranon, at mid-point between the olecranon and the styloid apophysis, and distally just above the styloid apophysis. Upper arm length will be measured from the acromion to the olecranon in centimeters. Forearm length will be measured from the olecranon to the styloid apophysis in centimeters. Upper arm cuffs will be placed at the mid-point between the acromion and the olecranon processes. All BP measurements will be obtained from the participants while in the sitting position, and the arm contralateral to the peripheral intravenous catheter (PIV) will be chosen for measurement. If the PIV has not yet been placed, the arm selection will be made by the patient. Baseline BP measurement will be performed at the upper arm after at least a 5-minute resting period utilizing a large-sized cylindrical cuff. Baseline BP measurement at the forearm will be performed using a conical forearm cuff previously validated in non-pregnant patients with arm circumferences greater than or equal to 40 cm23 (RADIAL-CUF, GE HealthCare, Milwaukee, Wisconsin). The forearm cuff will be placed 3 cm from the styloid process of the ulna palpable at the wrist.
After two minutes have elapsed since the baseline measurements, sequential, paired BP measurements will then be obtained by cycling either the upper arm cylindrical cuff or forearm conical cuff, waiting 60 seconds after the measurement, then cycling the other cuff. The choice of cuff to be cycled first (conical or cylindrical) will be block randomized. Additional sequential measurements will then be obtained 2, 4, 6, 8, and 10 minutes after the first set. After the initial measurements, the upper arm cuff will automatically cycle every 15 minutes. Thus, all patients will have six sets of sequential BP measurements. Any decision to initiate antihypertensive therapy will be made by the patient's obstetrical provider, using an institutional algorithm and with reference to cylindrical cuff pressures.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized, non blinded trial
| Arm | Type | Receives |
|---|---|---|
| Group 1 Upper arm cylindrical cuff | Active comparator | Device: Upper Arm Cylindrical Blood Pressure CuffIn 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. |
| Group 2 Forearm conical cuff | Experimental | Device: Forearm Conical Blood Pressure CuffIn 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (8 listed)
- 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
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 |
|---|---|---|
| Upper Arm Cylindrical Blood Pressure CuffAlso: Upper Arm Cylindrical Blood Pressure Cuff Inflated FirstIn Group 1, the upper arm cylindrical cuff is inflated first, followed by inflation of the forearm conical cuff. | Device | Group 1 Upper arm cylindrical cuff |
| Forearm Conical Blood Pressure CuffAlso: Forearm Conical Blood Pressure Cuff Inflated FirstIn Group 2, the forearm conical cuff is inflated first, followed by inflation of the upper arm cylindrical cuff. | Device | Group 2 Forearm conical cuff |
Primary outcome
Agreement between conical and cylindrical cuff systolic blood pressure as measured by mean absolute deviance
Time frame: Through study completion, an average of 1 year
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.
Agreement between conical and cylindrical cuff diastolic blood pressure as measured by mean absolute deviance
Time frame: Through study completion, an average of 1 year
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.
2 secondary outcomes
Agreement between conical and cylindrical cuff mean arterial pressure as measured by mean absolute deviance
Time frame: Through study completion, an average of 1 year
Likert scale patient satisfaction scores for conical and cylindrical cuff measurements
Time frame: Through study completion, an average of 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2026.
- Background: PubMed 23262963American 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.
- Background: PubMed 23876637Crane 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.
- Background: PubMed 17826400Chu 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.
- Background: PubMed 25912896Lutsiv 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.
- Background: PubMed 32541276Bicocca 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.
- Background: PubMed 17237733Bodnar 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.
- Background: PubMed 12859040O'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.
- Background: PubMed 23973398Lisonkova 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.
- Background: PubMed 25198279Lisonkova 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.
- Background: PubMed 30575675ACOG Practice Bulletin No. 202: Gestational Hypertension and Preeclampsia. Obstet Gynecol. 2019 Jan;133(1):1. doi: 10.1097/AOG.0000000000003018.
- Background: PubMed 28697109Creanga 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.
- Background: PubMed 21356004Cantwell 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.
- Individual participant dataSharing planned: No
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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.
Adithya Bhat, MD principal investigator
Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Upper Arm Cylindrical Blood Pressure Cuff and Forearm Conical Blood Pressure Cuff in people with Hypertension in Pregnancy and Hypertension, run by Northwestern University at 1 site in United States.
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 3 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 26 May 2026. 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 States. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Adithya Bhat, MD (312-472-3585, adithya.bhat@northwestern.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Agreement between conical and cylindrical cuff systolic blood pressure as measured by mean absolute deviance (time frame: Through study completion, an average of 1 year). 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 NCT06466161, which also lists 24 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 26 May 2026.