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. Author manuscript; available in PMC: 2022 Feb 28.
Published in final edited form as: N Engl J Med. 2021 Jul 29;385(5):436–444. doi: 10.1056/NEJMoa1913569

Table 4.

Maternal Secondary Outcomes.*

Outcome Hyperimmune Globulin (N = 205) Placebo (N = 193) Relative Risk (95% CI)
no. (%)
Gestational diabetes 5 (2.4) 7 (3.6) 0.67 (0.22–2.08)
Clinical chorioamnionitis 7 (3.4) 7 (3.6) 0.94 (0.34–2.63)
Oligohydramnios 10 (4.9) 3 (1.6) 3.14 (0.93–15.10)
Polyhydramnios 6 (2.9) 3 (1.6) 1.88 (0.45–14.06)
Gestational hypertension or preeclampsia 24 (11.7) 14 (7.3) 1.61 (0.86–3.03)
Placental abruption 3 (1.5) 1 (0.5) 2.82 (0.29–72.42)
Cesarean delivery 51 (24.9) 49 (25.4) 0.98 (0.70–1.38)
*

All available maternal data are shown; values are missing for one participant in the hyperimmune globulin group. The 95% confidence intervals are not adjusted for multiplicity, so these values should not be used to infer definitive treatment effects.

Exact confidence limits were calculated for rare outcomes with the use of StatXact software (Cytel).