Background
Methods
Study design and patients
Diagnostic criteria for hypertensive diseases in pregnancy
Diagnostic criteria for intrauterine growth restriction (IUGR)
Assessment of GlyFn, PAPPA2, PlGF, and sFlt-1
Point-of-care test (Lumella™ test system)
Participant/sample selection
Statistical analyses
Results
Baseline characteristics
At-risk women without PE | At-risk women with PE | p-value | |
---|---|---|---|
n | 119 | 32 | |
Maternal Characteristics | |||
Gestational age at sample collection (wk) | 29 (8.5) | 30 (7.3) | 0.14 |
Maternal age (yr) | 33 (7.5) | 33 (6.5) | 0.74 |
Maternal weight pre-pregnancy (kg) | 68 (23.8) | 65.5 (16.5.) | 0.7 |
Maternal weight at sample collection (kg) | 78 (22.8) | 80 (15.5) | 0.71 |
Maternal BMI (kg/m2) | 24.16 (7.8) | 25.67 (5.5) | 0.96 |
Systolic BP (mmHg) | 124 (19) | 160 (39) | < 0.001 |
Days before delivery | 54 (72) | 4 (10.8) | < 0.001 |
Ethnicity: Caucasian | 100 (84%) | 23 (72%) | 0.08 |
Nulliparity | 64 (54%) | 20 (63%) | 0.5 |
Co-morbidities | |||
Pre-existing chronic renal disease | 7 (6%) | 3 (9%) | 0.69 |
Pre-existing diabetes | 4 (3%) | 0 (0%) | 0.67 |
Pre-existing hypertension | 21 (18%) | 9 (28%) | 0.5 |
Gestational diabetes | 28 (24%) | 3 (9%) | 0.13 |
Gestational hypertension | 15 (13%) | 6 (19%) | 0.03 |
Delivery Outcomes | |||
Gestational age at delivery (wk) | 38.71 (2.9) | 30.64 (8) | < 0.001 |
Birth weight (g) | 2980 (12.1) | 1270 (1387.5) | < 0.001 |
Apgar score 5 min | 9 (2) | 8 (2) | < 0.001 |
Mode of delivery: C-section | 72 (61%) | 26 (81%) | 0.14 |
Preterm < 34 weeks | 33 (28%) | 28 (88%) | < 0.001 |
Small for Gestational Age (SGA) | 10 (8%) | 1 (3%) | 0.31 |
Intrauterine growth restriction (IUGR) | 27 (23%) | 15 (47%) | 0.01 |
Biomarker performance
At-risk women without PE | At-risk women with PE | p-value | |
---|---|---|---|
n | 119 | 32 | |
Biomarker Levels | |||
GlyFn (μg/mL) | 233 (92) | 457 (206) | < 0.001 |
PAPPA2 (ng/mL) | 72 (130) | 505 (330) | < 0.001 |
PlGF (pg/mL) | 275 (308) | 40 (57) | < 0.001 |
sFlt-1 (ng/mL) | 2186 (2170) | 9869 (6613) | < 0.001 |
Biomarker | AUC (95% CI) | Threshold | Sensitivity | Specificity |
---|---|---|---|---|
GlyFn (μg/mL) | 0.94 (0.90–0.98) | 315 | 91% | 86% |
PAPP-A2 (ng/mL) | 0.92 (0.87–0.97) | 200 | 87% | 77% |
PlGF (pg/mL) | 0.90 (0.85–0.96) | 100 | 81% | 83% |
sFlt-1 (ng/mL) | 0.92 (0.86–0.97) | 7000 | 84% | 91% |