NCT04012151

Brief Summary

Accurate blood pressure (BP) measurement is critical in peripartum care. The cuff and bladder sizes affects the accuracy of BP measurement. Current international BP measurement recommendations are based on mid-arm circumference (MAC). However, evidence have shown the discrepancies between these sizes, leading to inaccuracy of BP measurement. This study will measure arm and finger size of 300 parturients in third trimester to determine whether the MAC, finger measurement or body mass index (BMI) is the best clinical predictor for non-standard cuff sizes for BP measurement.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
8mo left

Started Jul 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress91%
Jul 2019Dec 2026

First Submitted

Initial submission to the registry

May 27, 2019

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 9, 2019

Completed
1 day until next milestone

Study Start

First participant enrolled

July 10, 2019

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 11, 2019

Completed
7.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Expected
Last Updated

October 9, 2024

Status Verified

October 1, 2024

Enrollment Period

5 months

First QC Date

May 27, 2019

Last Update Submit

October 8, 2024

Conditions

Hypertension, Pregnancy-Induced

Keywords

Blood pressure measurementConicity indexMid arm circumferenceCuff size

Outcome Measures

Primary Outcomes (2)

  • Arm length (Left, Right)

    The distance (cm) between the tip of the acromion process to the tip of the olecranon process on the posterior aspect of the arm, with the elbow in the flexed position.

    During antenatal visit (1-2 hours). One visit only

  • Mid Arm circumference (MAC)(Left, Right)

    The circumference (cm) of the arm at the mid-point of the arm length as measured above, with the arm hanging by the side.

    During antenatal visit (1-2 hours). One visit only

Secondary Outcomes (4)

  • Proximal arm circumference (Left, Right)

    During antenatal visit (1-2 hours). One visit only

  • Distal arm circumference (Left, Right)

    During antenatal visit (1-2 hours). One visit only

  • Finger circumference (Left, Right)

    During antenatal visit (1-2 hours). One visit only

  • Feedback on experiences of previous BP measurement

    During antenatal visit (1-2 hours). One visit only

Study Arms (1)

Pregnant cohort

Parturients of gestational age \>= 32 weeks will have measurements of arm length, MAC, proximal arm circumference, distal arm circumference, finger circumference to generate the conicity index.

Other: Physical measurementOther: Cuff size fitting

Interventions

Physical measurementOTHER

Parturients of gestational week \>= 32 weeks will have their arms and fingers measured to generate the conicity index.

Also known as: Measurement of fingers and arms
Pregnant cohort
Cuff size fittingOTHER

Fit on arm cuff and finger cuff as selected by investigators based on the measurement.

Also known as: Cuff fitting for arm and finger
Pregnant cohort

Eligibility Criteria

Age21 Years - 50 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsPregnant female in third trimester (\>=32 weeks gestation)
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Pregnant women in Singapore

You may qualify if:

  • American Society of Anaesthesiologists physical status 1 or 2 (ASA 1 or 2) parturients at 32 or more weeks of gestation
  • Multiparous or nulliparous;
  • Age 21-50 years old;
  • Undergoing Caesarean section in our institution.

You may not qualify if:

  • Emergent Caesarean section such that consent and measurements cannot be taken.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

KK Women's and Children's Hospital

Singapore, 229899, Singapore

Location

Related Publications (13)

  • O'Brien E, Asmar R, Beilin L, Imai Y, Mallion JM, Mancia G, Mengden T, Myers M, Padfield P, Palatini P, Parati G, Pickering T, Redon J, Staessen J, Stergiou G, Verdecchia P; European Society of Hypertension Working Group on Blood Pressure Monitoring. European Society of Hypertension recommendations for conventional, ambulatory and home blood pressure measurement. J Hypertens. 2003 May;21(5):821-48. doi: 10.1097/00004872-200305000-00001. No abstract available.

    PMID: 12714851BACKGROUND

  • Pickering TG, Hall JE, Appel LJ, Falkner BE, Graves J, Hill MN, Jones DW, Kurtz T, Sheps SG, Roccella EJ. Recommendations for blood pressure measurement in humans and experimental animals: part 1: blood pressure measurement in humans: a statement for professionals from the Subcommittee of Professional and Public Education of the American Heart Association Council on High Blood Pressure Research. Circulation. 2005 Feb 8;111(5):697-716. doi: 10.1161/01.CIR.0000154900.76284.F6.

    PMID: 15699287BACKGROUND

  • Perloff D, Grim C, Flack J, Frohlich ED, Hill M, McDonald M, Morgenstern BZ. Human blood pressure determination by sphygmomanometry. Circulation. 1993 Nov;88(5 Pt 1):2460-70. doi: 10.1161/01.cir.88.5.2460. No abstract available.

    PMID: 8222141BACKGROUND

  • Brown MA, Lindheimer MD, de Swiet M, Van Assche A, Moutquin JM. The classification and diagnosis of the hypertensive disorders of pregnancy: statement from the International Society for the Study of Hypertension in Pregnancy (ISSHP). Hypertens Pregnancy. 2001;20(1):IX-XIV. doi: 10.1081/PRG-100104165. No abstract available.

    PMID: 12044323BACKGROUND

  • Penaz J. Criteria for set point estimation in the volume clamp method of blood pressure measurement. Physiol Res. 1992;41(1):5-10.

    PMID: 1610779BACKGROUND

  • 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: 21317721RESULT

  • Fonseca-Reyes S, de Alba-Garcia JG, Parra-Carrillo JZ, Paczka-Zapata JA. Effect of standard cuff on blood pressure readings in patients with obese arms. How frequent are arms of a 'large circumference'? Blood Press Monit. 2003 Jun;8(3):101-6. doi: 10.1097/00126097-200306000-00002.

    PMID: 12900586RESULT

  • Bonso E, Saladini F, Zanier A, Benetti E, Dorigatti F, Palatini P. Accuracy of a single rigid conical cuff with standard-size bladder coupled to an automatic oscillometric device over a wide range of arm circumferences. Hypertens Res. 2010 Nov;33(11):1186-91. doi: 10.1038/hr.2010.146. Epub 2010 Aug 5.

    PMID: 20686489RESULT

  • 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: 22278143RESULT

  • 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.

    PMID: 27582825RESULT

  • Eley VA, Roberts L, Rickards L, Pelecanos A, Blackie A, Zhang C, Christensen R, Barrett HL. Arm and finger measurements in the third trimester: Implications for blood pressure measurement. Pregnancy Hypertens. 2018 Oct;14:105-109. doi: 10.1016/j.preghy.2018.09.002. Epub 2018 Sep 5.

    PMID: 30527095RESULT

  • Wang J, Thornton JC, Russell M, Burastero S, Heymsfield S, Pierson RN Jr. Asians have lower body mass index (BMI) but higher percent body fat than do whites: comparisons of anthropometric measurements. Am J Clin Nutr. 1994 Jul;60(1):23-8. doi: 10.1093/ajcn/60.1.23.

    PMID: 8017333RESULT

  • Lim MJ, Tan CW, Tan HS, Sultana R, Eley V, Sng BL. Correlation of patient characteristics with arm and finger measurements in Asian parturients: a preliminary study. BMC Anesthesiol. 2020 Aug 31;20(1):218. doi: 10.1186/s12871-020-01131-6.

    PMID: 32867679DERIVED

MeSH Terms

Conditions

Hypertension, Pregnancy-Induced

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesHypertensionVascular DiseasesCardiovascular Diseases

Study Officials

  • Farida Ithnin, MMED (Anaes)

    KK Women's and Children's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 27, 2019

First Posted

July 9, 2019

Study Start

July 10, 2019

Primary Completion

December 11, 2019

Study Completion (Estimated)

December 31, 2026

Last Updated

October 9, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Locations

SG(1)