Table 2.
Primary and secondary maternal outcomes
| Revealed PlGF (intervention; n=573) | Concealed PlGF (n=446) | ||
|---|---|---|---|
| Primary outcome | |||
| Number diagnosed with pre-eclampsia | 205 (36%) | 155 (35%) | |
| Time to diagnosis of pre-eclampsia in those diagnosed, days | 1·9 (0·5–9·2) | 4·1 (0·8–14·7) | |
| Secondary maternal outcomes | |||
| Number of women with adverse outcomes, defined by the fullPIERS consensus* | 22 (4%) | 24 (5%) | |
| Maternal deaths | 0 | 0 | |
| Eclampsia | 0 | 2 (<1%) | |
| Stroke | 0 | 2 (<1%) | |
| Parenteral infusion of third-line antihypertensive required | 1 (<1%) | 3 (1%) | |
| Myocardial infarction | 0 | 1 (<1%) | |
| Blood oxygen saturation <90% | 1 (<1%) | 1 (<1%) | |
| Intubation required (other than for caesarean section) | 0 | 1 (<1%) | |
| Pulmonary oedema | 2 (<1%) | 0 | |
| Transfusion of blood products required | 9 (2%) | 14 (3%) | |
| Platelet count <50 × 109 platelets per L | 4 (1%) | 4 (1%) | |
| Hepatic dysfunction | 1 (<1%) | 0 | |
| Severe acute kidney injury | 7 (1%) | 6 (1%) | |
| Dialysis required | 0 | 1 (<1%) | |
| Placental abruption | 4 (1%) | 5 (1%) | |
| Primary diagnosis | |||
| Pre-eclampsia | 175 (31%) | 126 (28%) | |
| Superimposed pre-eclampsia | 30 (5%) | 29 (7%) | |
| Gestational hypertension | 100 (17%) | 77 (17%) | |
| Gestational proteinuria | 29 (5%) | 20 (4%) | |
| Small-for-gestational-age infant only | 32 (6%) | 28 (6%) | |
| Chronic hypertension only | 37 (6%) | 28 (6%) | |
| Chronic hypertension with a small-for-gestational-age infant | 11 (2%) | 9 (2%) | |
| Renal disease | 7 (1%) | 4 (1%) | |
| Transient hypertension | 8 (1%) | 20 (4%) | |
| None of the above | 94 (16%) | 63 (14%) | |
| Subsequent diagnosis of pre-eclampsia by adjudication team | 50 (9%) | 42 (9%) | |
| Number with pre-eclampsia, diagnosed by adjudication | 255 (44%) | 197 (44%) | |
| Severe pre-eclampsia | 155 (27%) | 106 (24%) | |
| Time to diagnosis of pre-eclampsia (of those diagnosed within 4 weeks of trial entry), days | 1·3 (0·3–6·0) | 2·7 (0·7–8·9) | |
| Fetal growth abnormalities on ultrasound* | |||
| Received a scan | 438 (77%) | 307 (69%) | |
| Any growth abnormality identified | 142 (25%) | 67 (22%) | |
| Estimated fetal weight of less than the tenth percentile | 117 (27%) | 62 (20%) | |
| Absent or reversed end-diastolic flow | 43 (10%) | 16 (5%) | |
| Use of antihypertensives | 347 (61%) | 270 (61%) | |
| Systolic blood pressure of at least 160 mm Hg | 239 (42%) | 188 (42%) | |
| Labour onset | |||
| Spontaneous | 79 (14%) | 78 (17%) | |
| Induced | 263 (46%) | 210 (47%) | |
| Pre-labour caesarean section | 230 (40%) | 158 (35%) | |
| Preterm deliveries <37 weeks | 234 (41%) | 167 (37%) | |
| Indication for induction or caesarean section before labour† | |||
| Maternal hypertension not controlled by maximal therapy | 25 (5%) | 28 (8%) | |
| Maternal haematological abnormality | 10 (2%) | 3 (1%) | |
| Maternal biochemical abnormality | 15 (3%) | 16 (4%) | |
| Fetal compromise on ultrasound | 34 (7%) | 19 (5%) | |
| Fetal compromise on cardiotocography | 31 (6%) | 40 (11%) | |
| Severe maternal symptoms of pre-eclampsia | 48 (10%) | 27 (7%) | |
| Diagnosis of pre-eclampsia and reaching 37 weeks of gestation | 65 (13%) | 57 (16%) | |
| Gestational hypertension and reaching 37 weeks of gestation | 56 (11%) | 37 (10%) | |
| Chronic hypertension and reaching 37 weeks of gestation | 27 (6%) | 17 (5%) | |
| Enrolled in PHOENIX trial | 13 (3%) | 9 (2%) | |
| Other obstetric complications | 170 (34%) | 115 (31%) | |
| Mode of delivery | |||
| Spontaneous vaginal cephalic | 210 (37%) | 182 (41%) | |
| Assisted vaginal (forceps or vacuum) | 42 (7%) | 38 (9%) | |
| Vaginal breech | 1 (<1%) | 2 (<1%) | |
| Pre-labour caesarean section | 170 (30%) | 130 (29%) | |
| In-labour caesarean section | 150 (26%) | 94 (21%) | |
| Major post-partum haemorrhage | 49 (9%) | 48 (11%) | |
| Maternal health resource use | |||
| Mean outpatient visits (SE) | 6·14 (0·53) | 9·44 (0·81) | |
| Mean inpatient nights (SE) | 7·43 (0·36) | 7·26 (0·38) | |
Data are n (%), median (IQR), or mean (SD), unless otherwise indicated. For all fullPIERS outcome data not provided, no women had any of these events. Hepatic dysfunction was defined as an international normalisation ratio of more than 1·2 in the absence of disseminated intravascular coagulation (defined as abnormal bleeding and consumptive coagulopathy—ie, low platelets, abnormal peripheral blood film, or any of increased international normalisation ratio, increased activated partial thromboplastin time, low fibrinogen, or increased fibrin degradation products that are outside normal non-pregnancy ranges) or treatment with warfarin. Time ratio for the time to diagnosis of pre-eclampsia (primary outcome) 0·36 (95% CI 0·15–0·87). PlGF=placental growth factor.
Women could have several adverse events.
Of 494 women in the revealed group and 368 women in the concealed group.