Alternative Blood Pressure Measurements in OB Patients

NCT04291365 | Completed

• 1 other identifier: 5736
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The incidence of obesity has been increasing worldwide. In women with obesity, the anthropometric differences in the distribution of subcutaneous tissue can make accurate measurement of blood pressure difficult. A large upper arm circumference can prevent the use of a brachial artery blood pressure cuff and often prompts the use of alternative methods for blood pressure measurement, including measurements on the wrist or forearm. Outside of the obstetric population, there is evidence that if measurement of the blood pressure at the upper arm is not possible then measurement at the wrist can be used. Despite this evidence in non-pregnant patients, there is limited evidence in pregnancy regarding the accuracy of blood pressure measurements on the forearm or wrist. Accurate measurement of blood pressure is especially important in pregnancy to allow for prompt treatment of severe hypertension and for accurate diagnosis of hypertensive disorders of pregnancy. Error in measurement could lead to iatrogenic preterm birth or under treatment of severe hypertension, both which can lead to severe maternal and fetal morbidity and mortality. Additionally, it is biologically plausible that an increase in subcutaneous edema and vascular changes in pregnancy could lead to a larger discrepancy in blood pressure measurements between upper arm, forearm and wrist measurements. Due to the increasing epidemic of obesity and the increasing need for accurate alternative blood pressure measurements the investigators propose a prospective observational study of pregnant women ≥18 years old admitted to labor and delivery for any indication or seen for prenatal care in OBGYN clinic. A total of 20 women in each BMI class (normal, overweight (25-29.9), class 1 (30-34.9), class 2 (35-39.9), class 3 (\>40) will be enrolled (100 total). Participation will include a total of 9 blood pressure measurements, biometric measurements on the patient's upper arm, forearm, and wrist and a brief questionnaire. The investigators hypothesize that there will be a discrepancy between blood pressure measurements on the upper arm and forearm or wrist.

Conditions

Obesity; Blood Pressure

Outcome Measures

Primary Outcomes (3)

• Blood pressure brachial

  1 day

• Blood pressure radial

  1 day

• Blood pressure wrist

  1 day

Study Arms (4)

Normal weight

OTHER

Diagnostic Test: Blood pressure measurement

Obesity Class 1

OTHER

Diagnostic Test: Blood pressure measurement

Obesity Class 2

OTHER

Diagnostic Test: Blood pressure measurement

Obesity Class 3

OTHER

Diagnostic Test: Blood pressure measurement

Interventions

Blood pressure measurement DIAGNOSTIC_TEST

Study subjects will have a total of 9 blood pressure measurements taken (3 on upper arm, 3 on lower arm, and 3 on wrist)

Normal weight; Obesity Class 1; Obesity Class 2; Obesity Class 3

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \>=18 years old
• prenatal care at study hospital
• english speaking

You may not qualify if:

• Age \<18
• Active upper extremity DVT
• Inability to measure blood pressure on arm
• Unable to give consent

Sponsors & Collaborators

• Albany Medical College: lead

Study Sites (1)

Albany Medical Center

Albany, New York, 12208, United States

Location

Related Publications (1)

• Lende MN, Feustel PJ, Alafifi RL, Lynch TA. Impact of obesity on blood pressures measured at alternative locations during pregnancy. Am J Obstet Gynecol MFM. 2021 Sep;3(5):100441. doi: 10.1016/j.ajogmf.2021.100441. Epub 2021 Jul 3.

  PMID: 34229125 DERIVED

MeSH Terms

Conditions

Obesity

Interventions

Blood Pressure Determination

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Physical Examination

Study Officials

• Tara Lynch, MD

  Albany Medical College

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: February 27, 2020
• First Posted: March 2, 2020
• Study Start: March 1, 2020
• Primary Completion: July 1, 2021
• Study Completion: July 1, 2021
• Last Updated: July 20, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)