. 2024 May 16;4(5):e0003198. doi: 10.1371/journal.pgph.0003198

Table 4. Elevated CRP and AGP levels during pregnancy and risks of individual adverse outcomes, by treatment arm.

SP		LBW		SGA		PTB		Foetal loss		Neonatal loss		Any adverse foetal outcome		Low maternal weight gain
SP		aRR (95% CI)	P	aRR (95% CI)	P	aRR (95% CI)	P	aRR (95% CI)	P	aRR (95% CI)	P	aRR (95% CI)	P	aRR (95% CI)	P
Enrolment (Week 16–28)	CRP	1.30 (0.65, 2.62)	0.45	1.25 (0.78, 1.99)	0.35	1.26 (0.71, 2.22)	0.43	0.40 (0.05, 3.03)	0.37	1.21 (0.16, 9.03)	0.86	1.23 (0.88, 1.72)	0.23	0.86 (0.59, 1.25)	0.43
Enrolment (Week 16–28)	AGP	1.22 (0.58, 2.54)	0.60	1.30 (0.80, 2.12)	0.29	1.10 (0.60, 2.03)	0.76	1.41 (0.33, 5.95)	0.63	10.00 (0.96, 104.90)	0.055	1.40 (0.99, 1.98)	0.058	1.94 (1.36, 2.76)	0.0002
Visit 3	CRP	2.06 (0.97, 4.38)	0.06	1.80 (1.08, 2.97)	0.023	1.08 (0.50, 2.33)	0.85	**		2.00 (0.027, 14.73)	0.49	1.50 (1.00, 2.23)	0.049	1.22 (0.78, 1.92)	0.39
Visit 3	AGP	2.47 (1.05, 5.82)	0.039	1.37 (0.68, 2.79)	0.38	1.28 (0.50, 3.32)	0.61	6.57 (0.57, 76.2)	0.13	3.51 (0.43, 28.9)	0.24	1.48 (0.98, 2.44)	0.13	1.43 (0.82, 2.47)	0.21
Delivery	CRP	1.19 (0.51, 2.78)	0.69	0.76 (0.45, 1.26)	0.28	0.87 (0.43, 1.75)	0.70	1.17 (0.12, 11.48)	0.90	0.27 (0.02, 4.01)	0.34	0.85 (0.57, 1.27)	0.44	1.14 (0.72, 1.80)	0.58
Delivery	AGP	0.87 (0.40, 1.91)	0.73	0.83 (0.48, 1.43)	0.50	0.94 (0.46, 1.92)	0.87	6.67 (0.72, 62.06)	0.10	**		0.82 (0.54, 1.26)	0.37	1.42 (0.97, 2.08)	0.074
DP
Enrolment (Week 16–28)	CRP	1.15 (0.69, 1.91)	0.59	0.98 (0.66, 1.45)	0.91	1.12 (0.60, 2.10)	0.72	1.93 (0.53, 7.00)	0.32	0.40 (0.04, 3.70)	0.42	1.08 (0.80, 1.45)	0.63	1.03 (0.76, 1.40)	0.83
Enrolment (Week 16–28)	AGP	1.43 (0.86, 2.39)	0.67	1.22 (0.82, 1.81)	0.33	1.25 (0.66, 2.37)	0.49	1.17 (0.30, 4.62)	0.82	2.19 (0.36, 13.55)	0.40	1.31 (0.97, 1.77)	0.078	1.16 (0.85, 1.58)	0.35
Visit 3	CRP	2.44 (1.36, 4.37)	0.0028	1.43 (0.90, 2.28)	0.13	1.35 (0.55, 3.37)	0.51	**		1.72 (0.016, 18.7)	0.65	1.43 (0.99, 2.08)	0.059	1.09 (0.73, 1.63)	0.66
Visit 3	AGP	1.52 (0.67, 3.45)	0.32	1.11 (0.57, 2.16)	0.76	1.30 (0.42, 4.06)	0.65	4.96 (0.52, 47.34)	0.16	**		1.18 (0.71, 1.97)	0.52	1.11 (0.67, 1.83)	0.69
Delivery	CRP	0.83 (0.46, 1.50)	0.54	1.02 (0.64, 1.63)	0.93	1.19 (0.52, 2.74)	0.68	0.26 (0.06, 1.02)	0.055	0.70 (0.07, 6.66)	0.78	0.95 (0.66, 1.37)	0.78	0.85 (0.60, 1.20)	0.35
Delivery	AGP	1.39 (0.82, 2.34)	0.22	1.25 (0.84, 1.86)	0.26	2.55 (1.27, 5.11)	0.0085	13.11 (1.62, 106.23)	0.016	**		1.63 (1.20, 2.22)	0.0018	1.24 (0.90, 1.70)	0.18
DP+AZ
Enrolment (Week 16–28)	CRP	1.39 (0.82, 2.36)	0.22	1.26 (0.87, 1.82)	0.22	1.29 (0.69, 2.43)	0.43	1.57 (0.40, 6.14)	0.51	**		1.35 (0.99, 1.82)	0.054	0.99 (0.73, 1.35)	0.96
Enrolment (Week 16–28)	AGP	1.37 (0.79, 2.38)	0.26	1.49 (1.02, 2.17)	0.04	1.36 (0.70, 2.64)	0.36	0.61 (0.12, 3.10)	0.55	**		1.49 (1.09, 2.03)	0.012	0.89 (0.63, 1.24)	0.49
Visit 3	CRP	0.97 (0.37, 2.53)	0.95	1.20 (0.71, 2.02)	0.50	0.74 (0.24, 2.32)	0.60	**		5.03 (0.30, 83.44)	0.26	1.22 (0.79, 1.88)	0.37	0.97 (0.59, 1.57)	0.89
Visit 3	AGP	2.25 (1.02, 4.95)	0.044	1.65 (0.97, 2.80)	0.06	0.43 (0.06, 3.04)	0.40	**		**		1.41 (0.87, 2.29)	0.17	1.04 (0.58, 1.86)	0.89
Delivery	CRP	0.87 (0.48 (1.60)	0.66	1.09 (0.70, 1.69)	0.71	0.57 (0.29, 1.12)	0.10	0.41 (0.08, 2.28)	0.31	**		0.94 (0.66, 1.33)	0.72	1.00 (0.70, 1.45)	0.98
Delivery	AGP	1.61 (0.93, 2.78)	0.091	1.35 (0.92, 1.98)	0.13	2.20 (1.10, 4.40)	0.027	0.96 (0.16, 5.65)	0.97	**		1.57 (1.14, 2.15)	0.0057	1.24 (0.89, 1.72)	0.20
DP & DP+AZ
Enrolment (Week 16–28)	CRP	1.26 (0.87, 1.82)	0.22	1.11 (0.85, 1.46)	0.43	1.20 (0.77, 1.88)	0.42	1.75 (0.68, 4.50)	0.24	**		1.20 (0.97, 1.49)	0.092	1.01 (0.81, 1.26)	0.90
Enrolment (Week 16–28)	AGP	1.40 (0.95, 2.06)	0.09	1.35 (1.02, 1.79)	0.037	1.30 (0.81, 2.10)	0.27	0.88 (0.30, 2.59)	0.82	**		1.40 (1.12, 1.74)	0.033	1.02 (0.81, 1.29)	0.88
Visit 3	CRP	1.70 (1.04, 2.79)	0.035	1.31 (0.92, 1.87)	0.13	1.00 (0.49, 2.05)	0.99	**		2.78 (0.44, 17.39)	0.28	1.33 (1.00, 1.77)	0.053	1.03 (0.75, 1.42)	0.84
Visit 3	AGP	1.85 (1.04, 3.27)	0.036	1.37 (0.90, 2.08)	0.14	0.81 (0.30, 2.16)	0.68	**		**		1.30 (0.91, 1.84)	0.16	1.08 (0.73, 1.58)	0.70
Delivery	CRP	0.85 (0.56, 1.30)	0.46	1.05 (0.76, 1.46)	0.75	0.80 (0.48, 1.35)	0.41	0.31 (0.10, 0.90)	0.03	**		0.94 (0.73, 1.22)	0.66	0.92 (0.71, 1.18)	0.51
Delivery	AGP	1.48 (1.01, 2.18)	0.044	1.30 (0.99, 1.71)	0.064	2.37 (1.44, 3.90)	0.0007	3.83 (1.18, 12.38)	0.025	**		1.60 (1.28, 2.00)	<0.0001	1.24 (0.99, 1.56)	0.067

CRP, C-reactive protein; AGP, alpha-1-acid glycoprotein. SP, sulphadoxine-pyrimethamine; DP, dihydroartemisinin-piperaquine; AZ, azithromycin. Visit 3, third treatment with IPTp 24–36 gestation weeks). The composite adverse birth outcome variable includes: low birth weight (LBW) defined as <2500 g, preterm birth (PTB), defined as <37 gestational weeks, foetal loss defined as a non-live birth, small for gestational age (SGA) defined as birth weight lower than the 10^th centile of the intergrowth-21^st standards [1] and/or neonatal loss. Low gestational weight gain was defined as the bottom quartile of the IMPROVE study population (<164 g/week). Adjusted Risk Ratios (aRR) and 95% confidence intervals were estimated using logistic regression and adjusted for maternal age, maternal height, mid-upper arm circumference, gravidity, number of antenatal visits and study site, and included an interaction term between inflammatory marker and treatment arm. Significance is defined as P <0.05 and significant findings are highlighted with bold text. ** aRRs were not always able to be estimated for neonatal death or foetal loss as these outcomes occurred infrequently.