TABLE 1.
Summary of pregnancy outcomes, cytokines, and prostaglandins in pregnant NHPsa
| Outcome | Saline (n = 6) | GB37 (n = 5) | GB37ΔhylB (n = 5) |
P
|
||
|---|---|---|---|---|---|---|
| Saline vs GB37 | GB37 vs GB37ΔhylB | Saline vs GB37ΔhylB | ||||
| Primary and composite outcomes, no. (%) | ||||||
| Adverse outcomeb | 0 (0) | 5 (100) | 1 (20) | 0.0009 | 0.02 | NS |
| Preterm laborc | 0 (0) | 4 (80) | 1 (20) | 0.01 | 0.1 | NS |
| Microbial invasion of the amniotic cavity and fetal bacteremia | 0 (0) | 5 (100) | 1 (20) | 0.0009 | 0.02 | NS |
| Peak contractions, AF cytokines, and prostaglandins, mean peak pg/ml (SEM) | ||||||
| Hourly contraction area | 1,326.7 (506.58) | 5,606.0 (1,165.1) | 3,087.4 (1,050.0) | 0.04 | NS | NS |
| IL-1β | 31.61 (20.59) | 1,754.8 (1,112.7) | 597.65 (583.42) | 0.09 | NS | NS |
| TNF-α | 26.13 (11.44) | 574.58 (285.82) | 97.58 (39.43) | 0.07 | NS | NS |
| IL-6 | 7,091.1 (2,642.2) | 2,827.8 (1,331.3) | 2,404.1 (1,356.5) | NS | NS | NS |
| IL-8 | 888.07 (321.53) | 2,120.5 (1,383.3) | 1,629.7 (1,498.2) | NS | NS | NS |
| PGE2 | 509.83 (247.84) | 1,160.9 (647.40) | 289.23 (116.69) | NS | NS | NS |
| PGF2α | 424.31 (169.64) | 1,808.1 (887.27) | 164.93 (45.91) | NS | 0.08 | NS |
| Fetal cytokines | ||||||
| IL-1β | 0.80 (0.60) | 2.152 (0.8584) | 1.128 (0.8645) | NS | NS | NS |
| TNF-α | 2.268 (1.127) | 0.01 (0.0) | 0.01 (0.0) | 0.04 | NS | 0.04 |
| IL-6 | 3.639 (1.852) | 1,049.6 (722.10) | 44.74 (41.58) | 0.049 | NS | NS |
| IL-8 | 574.06 (314.04) | 2,648.8 (1,674.1) | 2,576.2 (1,551.3) | NS | NS | NS |
The primary outcomes are shown as “number (%)” and were compared among groups using Barnard’s test. Amniotic fluid (AF) cytokines, prostaglandins and fetal plasma cytokines are expressed as mean peak (SEM) in pg/ml. Hourly contraction area is expressed in mm Hg × s/h. Cytokines (IL-1β, TNF-α, IL-6, and IL-8) and prostaglandins (PGE2 and PGF2α) were compared by using one-way ANOVA with Bonferroni’s correction. Statistical analyses were conducted using Intercooled STATA 8.2 for Windows 2000 (StataCorp) or SciStatCalc. P values of <0.05 are indicated in boldface. NS, P > 0.100.
Adverse outcome is a composite metric representing preterm labor or microbial invasion of the amniotic cavity with fetal bacteremia.
Preterm labor was defined as progressive cervical dilation associated with increased and sustained uterine activity.