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Trimester-Specific Reference Intervals for 31 routine biochemical parameters used in pregnancy care *De rvan L 1 , * Bogdanet  D 1 , Finn O 2 ,  Groenendijk  W 2 , Islam NM 2 , Doheny H 2 , Griffin TP 1 , Dunne FP 1 , O’Shea PM 1,2 .

Discipline of Medicine, School of Medicine, National University of Ireland, Galway, Ireland . Department of Clinical Biochemistry,  Saolta  University Health Care Group (SUHCG), University Hospital Galway, Ireland. *Authors Contributed Equally

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BMI 225kg/m2 (n=382)
Incomplete Medical History (n=9)
Known Medical Condition prior
to pregnancy (n=238)
>3 Miscarriage (n=6)
Current smoker at time
of booking (n=$O)
557
Systemic hypertension at booking
BP: >140/90mmHg (n=7)
Non-white European
87)
GA weeks (n=184)
Missing samples (n=155)
Reference Population With blood samples in each trimester (n: 124)

Prospective cross-sectional study of apparently health pregnant volunteers Enrolment inclusion criteria: Signed informed consent Age  ≥ 18 years White European Body mass index <25kg/m 2 Blood pressure <140/90mmHg No previous or new diagnosis of cardiac, thyroid, liver, metabolic bone disease or anaemia Pregnancy trimester was defined as  T1: up to 13weeks+6days (97days) T2: 14-27weeks+6days (98-195days) T3: >28-41weeks+6days (196-293days 31 biochemical ISO15189:2012 accredited tests were analysed using the Roche  Cobas ® platform following standard operating procedures RIs were defined according to the International Federation of Clinical Chemistry (IFCC) recommended method

Variable
tGA (Days)
Nulliparous (0/0)
*SBP (rnmHg)
*DBP (mmHg)
Reference population
(n 124)
89 84 - 93
22.5 1.0 - 23.
48.9
.8 (±10.8)
(±8.8)
GDM: Gestational Diabetes, GA: •Gestational age: weeks (97 days); BMI: Body Mass Index:
SBP: Systolic blood pressure, DBP: Diastolic blood pressure. Data presented as•Mean ± standard
deviation or tmedian (interquartile range) as appropriate

Table 1.  Baseline characteristics of the reference population

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Table 2.  Established Trimester-Specific Reference Intervals for 31 biochemical tests routinely requested for pregnancy care

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This study provides normative biological intervals established in a healthy pregnant European population for 31 commonly requested biochemical parameters.  These RIs will be a valuable aid to result interpretation, healthcare and management of pregnant women.  We now plan to examine the potential clinical utility of these routine biomarkers in pregnancies complicated by Gestational Diabetes Mellitus.

CLSI (2008) Clinical and Laboratory Standards Institute EP28- A3c. Defining, establishing, and verifying reference intervals in the clinical laboratory; approved guideline—third edition. Wayne, PA: 2008 Islam MN  et al.  Reference intervals for commonly requested biochemical and haematological parameters in a healthy Irish adult Caucasian population .   Ir  J Med Sci. 2021 Feb 11.  doi : 10.1007/s11845-021-02535-0

Apparently Healthy Pregnant &
Non—pregnant Adult Cohorts Cornpared
Analyte (Sengn)
Profile
("MTOVL)
(rr«roVt_)
Chkvk:ie
Urea
CVTÜVL)
T. Protein
Abumin (A-IL)
T. Bili
AST (U 'L)
ALT (U/L)
VGT (u FL)
ALP CU,'L)
LDH
Ace:is (wyoVL)
Arnyiase (U 'L)
Bone Profile
T _ (rrg-roVL)
M (rrrroVL)
Phosphate (rru-roVL)
Parathyrok:i Hcvrt*yw (rwtJ
C—reactive proteh (rrVL)
T (nø•-'L_)
(rTVTÜVL)
I ron (vrnoVL_)
Trans ferrin (rrVL)
Thyroid FuncUon Tests
FT4
TSH (mlU,'L)
Lipid
TRIG (n-«roVL)
HDL
LDL
Trimester (T)
.p—vaue
0.0451
vs
n.p—value
0.2786
0.3275
0.1514
o. 1462
Vs
u 1227
vs
o. 1043
0.7234
0.4978
0.5491
0.1115
Vs
0-3257
vs
Ap—vaue
0.7091
o.CN)17
0-7480
o.cn17
0.61 16
0.2875
0.0575
vs
Ap—vaue
0-7273
0.0111

Table 3.   Analyte reference values between cohorts compared

ND: Not done; *Kruskal-Wallis ANOVA; ^Mann-Whitney U-test

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