Outcome | Control (SPCQ and placebo) n = 1,374 | Intervention (SPAZ) n = 1,378 | Risk ratio (95% CI) | P | ||
---|---|---|---|---|---|---|
All adverse events | 414 | (30.1) | 397 | (28.8) | 0.96 (0.85–1.07) | 0.447 |
All serious adverse events (SAE) | 174 | (12.7) | 181 | (13.1) | 1.04 (0.85–1.26) | 0.712 |
Maternal a | 100 | (7.3) | 104 | (7.5) | 1.04 (0.80–1.35) | 0.788 |
No. admittedb | 94 | (6.8) | 90 | (6.5) | 0.96 (0.72–1.26) | 0.745 |
No. of mothers with 2 SAEs | 4 | (0.3) | 1 | (0.1) | 0.25 (0.03–2.23) | 0.218 |
No. drug-related SAEs | 0 | (0.0) | 0 | (0.0) | – | – |
Characteristics of maternal SAEs c | Â | Â | Â | Â | Â | Â |
  Maternal death | 1 | (0.1) | 2 | (0.2) | 1.99 (0.18–22.0) | >0.999 |
  Spontaneous abortion | 4 | (0.3) | 1 | (0.1) | 0.24 (0.03–2.23) | 0.218 |
  Stillbirth | 15 | (1.1) | 25 | (1.8) | 1.66 (0.88–3.14) | 0.113 |
  Emergency caesarean section | 24 | (1.8) | 24 | (1.7) | 1.00 (0.57–1.75) | 0.992 |
  Hypertensive disorders of pregnancy | 11 | (0.8) | 12 | (0.9) | 1.09 (0.48–2.46) | >0.999 |
  Malaria | 6 | (0.4) | 3 | (0.2) | 0.50 (0.12–1.99) | 0.314 |
  Other infections | 10 | (0.8) | 6 | (0.4) | 0.60 (0.22–1.64) | 0.330 |
  Anaemia | 3 | (0.2) | 2 | (0.2) | 0.66 (0.11–3.97) | 0.687 |
  Placenta praevia | 2 | (0.2) | 3 | (0.2) | 1.50 (0.25–8.94) | >0.999 |
  Antepartum haemorrhage | 3 | (0.2) | 4 | (0.3) | 1.33 (0.30–5.93) | >0.999 |
  Preterm labour | 16 | (1.2) | 6 | (0.4) | 0.31 (0.11–0.85) | 0.034 |
  Preterm premature rupture of membranes | 13 | (1.0) | 4 | (0.3) | 0.31 (0.10–0.94) | 0.030 |
  Prolonged prelabour rupture of membranes | 2 | (0.2) | 1 | (0.1) | 0.50 (0.05–5.49) | 0.624 |
  Induction of labour (post-dates) | 0 | (0.0) | 4 | (0.3) | – | 0.125 |
  Postpartum haemorrhage | 16 | (1.2) | 23 | (1.7) | 1.43 (0.76–2.70) | 0.333 |
  Otherd | 3 | (0.2) | 3 | (0.2) | 1.00 (0.20–4.93) | >0.999 |
Neonatal | 74 | (5.4) | 77 | (5.6) | 1.04 (0.76–1.42) | 0.816 |
  No. admittedb | 61 | (4.4) | 67 | (4.9) | 1.10 (0.78–1.54) | 0.599 |
  No. of babies with two SAEs | 0 | (0.0) | 1 | (0.0) | – | >0.999 |
  No. drug-related SAEs | 0 | (0.0) | 0 | (0.0) | – | - |
Characteristics of neonatal SAEs c | Â | Â | Â | Â | Â | Â |
  Congenital abnormalitye | 8 | (0.6) | 10 | (0.7) | 1.25 (0.49–3.14) | 0.814 |
  Neonatal death | 19 | (1.4) | 11 | (0.8) | 0.58 (0.28–1.21) | 0.140 |
  Prematurity | 15 | (1.1) | 9 | (0.7) | 0.60 (0.26–1.36) | 0.227 |
  Low birthweight | 20 | (1.5) | 10 | (0.7) | 0.50 (0.23–1.06) | 0.069 |
  Infection | 42 | (3.1) | 37 | (2.7) | 0.88 (0.57–1.36) | 0.570 |
  Birth asphyxia | 16 | (1.2) | 18 | (1.3) | 1.12 (0.57–2.19) | 0.736 |
  Meconium aspiration syndrome | 10 | (0.7) | 14 | (1.0) | 1.40 (0.62–3.13) | 0.416 |
  Cephalohaematoma | 3 | (0.2) | 6 | (0.4) | 1.99 (0.50–7.96) | 0.507 |
  Jaundice | 2 | (0.2) | 3 | (0.2) | 1.50 (0.25–8.94) | >0.999 |
All non-serious adverse events (AEs) | 240 | (17.5) | 216 | (15.7) | 0.94 (0.80–1.11) | 0.456 |
  No. women with two AEs | 10 | (0.7) | 13 | (0.9) | 1.30 (0.57–2.95) | 0.535 |
  No. drug-related maternal AEf | 149 | (10.8) | 144 | (10.5) | 0.96 (0.78–1.20) | 0.737 |
  No. drug-related formal withdrawalsg | 7 | (0.5) | 8 | (0.6) | 1.14 (0.41–3.13) | >0.999 |
  No. women with two drug-related AEs | 3 | (0.2) | 9 | (0.7) | 2.99 (0.81–11.03) | 0.145 |
Characteristics of drug-related maternal AEs | Â | Â | Â | Â | Â | Â |
  Vomiting | 82 | (6.0) | 74 | (5.4) | 0.90 (0.66–1.22) | 0.498 |
  Dizziness | 56 | (4.1) | 33 | (2.4) | 0.59 (0.39–0.90) | 0.013 |
  Nausea | 37 | (2.7) | 43 | (3.1) | 1.16 (0.75–1.79) | 0.544 |
  Pruritus | 17 | (1.2) | 9 | (0.7) | 0.53 (0.24–1.18) | 0.120 |
  Weakness | 13 | (1.0) | 13 | (0.9) | 1.00 (0.46–2.14) | 0.994 |
  Abdominal pain | 3 | (0.2) | 12 | (0.9) | 4.32 (1.23–15.13) | 0.021 |
  Headache | 8 | (0.6) | 5 | (0.4) | 0.62 (0.20–1.90) | 0.422 |
  Diarrhoea | 1 | (0.1) | 3 | (0.2) | 2.99 (0.31–28.7) | 0.625 |
  Facial swelling (mild) | 3 | (0.2) | 1 | (0.1) | 0.33 (0.04–3.19) | 0.374 |
  Feeling hot | 3 | (0.2) | 0 | (0.0) | – | 0.124 |
  Dyspepsia | 0 | (0.0) | 4 | (0.3) | – | 0.125 |
  Loss of appetite | 0 | (0.0) | 2 | (0.2) | – | 0.500 |
  Other | 5 | (0.4) | 7 | (0.1) | 1.40 (0.44–4.39) | 0.774 |