Alternative Blood Pressure Measurements in OB Patients

NCT ID: NCT04291365

Last Updated: 2021-07-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-03-01
• Study Completion Date: 2021-07-01

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Normal weight

Group Type: OTHER

Blood pressure measurement

Intervention Type: 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)

Obesity Class 1

Group Type: OTHER

Blood pressure measurement

Intervention Type: 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)

Obesity Class 2

Group Type: OTHER

Blood pressure measurement

Intervention Type: 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)

Obesity Class 3

Group Type: OTHER

Blood pressure measurement

Intervention Type: 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)

Interventions

Blood pressure measurement

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

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 89 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Albany Medical College

OTHER

Sponsor Role: lead

Responsible Party

Tara Lynch

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Tara Lynch, MD

Role: PRINCIPAL_INVESTIGATOR

Albany Medical College

Locations

Albany Medical Center

Albany, New York, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 34229125 (View on PubMed)

Other Identifiers

5736

Identifier Type: -

Identifier Source: org_study_id