Table 3 Primary and secondary endpoints.
Primary and secondary endpoints | ||||
|---|---|---|---|---|
Total (n = 1104) | Maternal HD (n = 1011) | Combined MF-HD (n = 93) | P | |
Primary endpoints: adverse fetal and neonatal events | ||||
Fetal events (total) | 287 (26) | 252 (24.9) | 35 (37.6) | 0.008 |
Fetal or neonatal death (up to 28 days) | 5 (0.5) | 4 (0.4) | 1 (1.1) | 0.370 |
Preterm birth (<37 weeks’) | 131 (11.9) | 110 (10.9) | 21 (22.6) | 0.001 |
Extreme preterm birth (<32 weeks’) | 22 (2.0) | 20 (2.0) | 2 (2.2) | 0.909 |
Gestational age at deliverya | 39 (38–40) | 39 (38–40) | 38 (37.5–40) | 0.220 |
SGA (less than 10th centile) | 180 (16.3) | 162 (16) | 18 (19.4) | 0.406 |
Primary endpoint: obstetric events | ||||
Preeclampsia | 51 (4.6) | 47 (4.6) | 4 (4.3) | 0.879 |
Secondary endpoints: adverse fetal and neonatal events | ||||
Birth weightsa | 3200 (2840–3546) | 3200 (2855–3545) | 3200 (2600–3550) | 0.205 |
RDS | 33 (3.0) | 27 (2.7) | 6 (6.5) | 0.047 |
IVH | 3 (0.5) | 3 (0.5) | 0 | 1.000 |
Other congenital fetal abnormalitiesb | 32 (2.9) | 25 (2.5) | 7 (7.5) | 0.008 |
NICU | 160 (14.5) | 130 (12.9) | 30 (32.3) | <0.001 |
Secondary endpoints: obstetric events | ||||
Obstetric death | 0 | 1.000 | ||
Post-partum hemorrhage | 47 (4.3) | 47 (4.6) | 0 (0.0) | 0.997 |
