TABLE 8.
Maternal and offspring perinatal outcomes and adverse events between the intervention group and the usual care control group
| Participants who experienced pregnancy at ≥14 wk (analytical cohort) | Intervention (n=89) | Usual care (n=80) | Unadjusted OR (95% CI) | Adjusted ORa (95% CI) |
|---|---|---|---|---|
| GDMb | 22 (24.7) | 28 (35.4) | 0.60 (0.31–1.17) | 0.67 (0.33–1.36) |
| HTN-Pc | 16 (18.0) | 13 (16.3) | 1.13 (0.51–2.52) | 1.00 (0.43–2.36) |
| Congenital anomaliesd | 6 (6.7) | 5 (6.4) | 1.06 (0.31–3.60) | — |
| Participants who delivered offspring | Intervention (n=85) | Usual care (n=76) | Unadjusted OR (95% CI) | Adjusted ORa (95% CI) |
| Cesarean delivery | 31 (36.5) | 26 (34.2) | 1.10 (0.58–2.11) | 0.88 (0.43, 1.83) |
| Preterm birth (<37 wk) | 7 (8.2) | 5 (6.6) | 1.27 (0.39–4.20) | 1.41 (0.42–4.81) |
| All participants randomized into study | Intervention (n=163) | Usual care (n=162) | Unadjusted OR (95% CI) | Adjusted ORa (95% CI) |
| Pregnancy losse | 8 (4.9) | 19 (11.8) | 0.39 (0.17–0.92) | 0.39 (0.16–0.92) |
| Fracturef | 2 (1.2) | 3 (1.9) | 0.65 (0.11–3.97) | — |
| Hospitalization unrelated to deliveryf | 14 (8.6) | 6 (3.7) | 2.43 (0.91–6.48) | — |
| Offspring | Intervention (n=85) | Usual care (n=76) | Unadjusted OR (95% CI) | Standardized differenceg (95% CI) |
| Birthweight, g (mean [SD]) | 3465.7 (585.6) | 3493.4 (594.4) | — | −0.05 (−0.36 to 0.26) |
| Birthweight for gestational age, z-score,h (mean [SD]) | 0.2 (0.9) | 0.3 (1.0) | — | −0.06 (−0.37 to 0.25) |
| LGAi | 14 (16.5) | 13 (17.1) | 0.96 (0.42–2.19) | — |
| SGAj | 6 (7.1) | 1 (1.3) | 5.70 (0.67–48.44) | — |
| Hypoglycemiad | 14 (16.5) | 16 (21.6) | 0.71 (0.32–1.59) | — |
| Respiratory morbidityd | 11 (12.9) | 8 (10.8) | 1.23 (0.47–3.23) | — |
Data are presented as number (percentage), unless otherwise specified.
CI, confidence interval; HTN-P, gestation hypertension; GDM, gestational diabetes mellitus; LGA, large for gestational age; OR, odds ratio; SD, standard deviation; SGA, small for gestational age.
Adjusted for whether participant had the condition in a previous pregnancy;
GDM analysis excludes 1 person who had type 2 diabetes at randomization;
Includes hypertension with onset during pregnancy and preeclampsia or eclampsia;
Data on congenital anomalies, hypoglycemia, and respiratory morbidity are missing for 2 mother-offspring pairs;
Includes miscarriage and ectopic pregnancy before 20 weeks’ gestation; women with more than 1 episode of pregnancy loss were only counted once;
Women with more than 1 hospitalization or fracture were only counted once;
Measure of association is different because newborn weights are continuous;
Adjusted for gestational age and sex using methods of Oken et al21;
Birthweight >90th percentile for age;
Birthweight <10th percentile for age.