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OpenTrials
Completed

NCT Number: NCT04291365

Alternative Blood Pressure Measurements in OB Patients

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.

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Key information

Age range

18 year–89 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Albany Medical Center

Albany, New York, 12208, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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)

Primary outcomes

  1. Blood pressure brachial

    Time frame: 1 day

  2. Blood pressure radial

    Time frame: 1 day

  3. Blood pressure wrist

    Time frame: 1 day

Sponsors and collaborators

Lead sponsor

Albany Medical College

Other

Registry information

Official study title

Assessing the Use of Alternative Methods of Blood Pressure Measurement in Obstetric Patients

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Mar 2, 2020
Registry last updated
Jul 20, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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