Table 2. Clinical Conditions Reported during Pregnancy, Among Trial Completers (n=161).
Clinical Conditions of Pregnancy as defined by the following: (1) Preterm labor as documented in medical record that included hospitalization greater than 24 hours. (2) Preterm delivery less than 37 0/7 weeks of gestation as documented in medical record. (3) Hypertensive Disorders of Pregnancy as documented in the medical record, which included any one of the following—gestational hypertension, preeclampsia, HELLP Syndrome, worsening hypertension in women with existing hypertension. (4) Infection, Any—a new infection that was documented in the medical record that included urinary tract infections, bacterial vaginosis, flu or flu-like illness, or any illness that required antibiotic or antifungal therapy (did not include preexisting herpes simplex infections for which antiviral therapy was prescribed). (5) Gestational Diabetes as documented in the medical record following glucose tolerance test (did not include those with preexisting type 1 or type 2 diabetes). 6. Non-Repeat Cesarean Section—mode of delivery by cesarean section that was not repeat cesarean or vaginal delivery. 7. Any Comorbidity Listed Above—any of the comorbidities 1–6 listed above.
| Medical Condition | Total Cohort N=161 |
2000 IU/day N=83 |
4000 IU/day N=78 |
p-value |
|---|---|---|---|---|
| Preterm labor | 37 (23.0%) | 24 (28.9%) | 13 (16.7%) | 0.091 |
| Preterm delivery (<37 wks) | 19 (11.8%) | 10 (12.1%) | 9 (11.5%) | 1.00 |
| Preterm labor or delivery | 50 (31.1%) | 29 (34.9%) | 21 (26.9%) | 0.31 |
| Hypertension | 4 (2.5%) | 3 (3.6%) | 1 (1.3%) | 0.62 |
| Infection | 74 (46.0%) | 41 (49.4%) | 33 (42.3%) | 0.43 |
| Gestational diabetes | 18 (11.2%) | 11 (13.3%) | 7 (9.0%) | 0.46 |
| Any above comorbidity | 107 (66.5%) | 58 (54.2%) | 49 (45.8%) | 0.40 |
| Total comorbidity count | 0.044 | |||
| No comorbidities | 54 | 25 (30.1%) | 29 (37.2%) | |
| 1 comorbidity | 61 | 31 (37.4%) | 30 (38.5%) | |
| 2 comorbidities | 21 | 8 (9.6%) | 13 (16.7%) | |
| 3 comorbidities | 20 | 15 (18.1%) | 5 (6.4%) | |
| 4 comorbidities | 5 | 4 (4.8%) | 1 (1.3%) | |
| Non-repeat Caesarean | 58 (36.0%) | 31 (53.5%) | 27 (46.6%) | 0.61 |
Missing data as follows: nonrepeat Caesarean, n=13. P-values for the comparison of 2000 IU/day vs. 4000 IU/day were obtained using Fisher’s exact test, except for the analysis of total comorbidity count, which used Poisson regression.