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Table 4 Incidence proportions of pregnancy-related events of interest by study cohort for the entire study period

From: Facilitating safety evaluation in maternal immunization trials: a retrospective cohort study to assess pregnancy outcomes and events of interest in low-risk pregnancies in England

 

AP cohort N = 298 155

AP24+ cohort N = 208 328

LR cohort N = 137 932

n

Incidence/10 000 (95% CI)

n

Incidence/10 000 (95% CI)

n

Incidence/10 000 (95% CI)

Assessed from the start of pregnancy to 90 days post-pregnancy end date

Maternal sepsis

220

7.4 (6.4–8.4)

174

8.4 (7.1–9.7)

103

7.5 (6.1–9.1)

Vaginal or intrauterine hemorrhage

20 794

697.4 (688.2–706.7)

16 649

799.2 (787.4–811.1)

10 055

729.0 (715.1–743.0)

Pre-eclampsia

4 581

153.6 (149.0–158.4)

4 340

208.3 (202.0–214.8)

2 558

185.5 (178.1–193.0)

Eclampsia

224

7.5 (6.5–8.6)

213

10.2 (8.9–11.7)

114

8.3 (6.8–10.0)

Pregnancy-related hypertension

1 175

39.4 (37.1–41.8)

1 114

53.5 (50.3–56.8)

556

40.3 (36.9–43.9)

Liver or biliary disease

36

1.2 (0.8–1.7)

33

1.6 (1.1–2.3)

7

0.5 (0.2–1.1)

Assessed from the start of pregnancy to pregnancy end date

Premature/preterm labor

6 417

215.2 (209.9–220.6)

6 094

292.5 (285.2–300.0)

3 590

260.3 (251.8–269.0)

Labor protraction/arrest disorders

16 148

541.6 (533.2–550.1)

15 675

752.4 (740.9–764.1)

10 683

774.5 (760.2–789.1)

Oligohydramnios

1 552

52.1 (49.5–54.7)

1 463

70.2 (66.6–73.9)

827

60.0 (55.9–64.2)

Polyhydramnios

1 663

55.8 (53.1–58.6)

1 612

77.4 (73.6–81.3)

922

66.8 (62.5–71.4)

Intrauterine growth restriction/poor fetal growth

4 412

148.0 (143.6–152.5)

4 240

203.5 (197.4–209.8)

2 370

171.8 (164.9–179.0)

Gestational diabetes mellitus

5 352

179.5 (174.5–184.6)

5 199

249.6 (242.6–256.6)

2 941

213.2 (205.4–221.3)

Assessed during period as stated in Table 1

Maternal death

20

0.7 (0.4–1.1)

14

0.7 (0.3–1.2)

11

0.8 (0.4–1.5)

Preterm premature rupture of membranes

3 362

112.8 (109.0–116.7)

2 918

140.1 (135.0–145.2)

1 730

125.4 (119.6–131.5)

Fetal/perinatal distress or asphyxia

39 319

1 318.7 (1 306.2–1 331.3)

38 006

1 824.3 (1 807.4–1 841.3)

25 283

1 833.0 (1 812.3–1 853.9)

  1. AP All Pregnancies, AP24+ All Pregnancies with gestational age ≥ 24 weeks, CI confidence interval, Incidence incidence proportion per 10 000 pregnancies, LR Low-Risk pregnancies, n number of pregnancies belonging to the specified category, N number of pregnancies included in the analysis in each cohort. If a particular pregnancy-related event of interest occurred several times for the same pregnancy, it was only counted once for that pregnancy