Table 5.
Safety-related measures
| Incidence | Overall | Control | Intervention |
|---|---|---|---|
|
| |||
| Maternal | |||
| Gestational diabetes mellitusa | 6 (19.4) | 3 (18.8) | 3 (20.0) |
| Preeclampsia | 7 (22.6) | 2 (12.5) | 5 (33.3) |
| Eclampsia | 2 (6.5) | 1 (6.3) | 1 (6.7) |
| Primary C-section | 14 (45.2) | 7 (43.8) | 7 (46.7) |
| Neonatal | |||
| NICU admissionb,c | 5 (16.1) | 2 (12.5) | 3 (20.0) |
| Prematurity (<37 weeks GA) | 10 (32.3) | 4 (25.0) | 6 (40.0) |
| Neonatal hypoglycemiad | 4 (13.3) | 2 (13.3) | 2 (13.3) |
| Other complications | |||
| Birth traumae | 1 (3.3) | 0 (0.0) | 1 (6.7) |
| Respiratory morbidityf | 4 (13.3) | 1 (6.7) | 3 (20.0) |
Notes: Medical diagnoses and adverse events abstracted from clinical records.
Screened between 24 and 27 weeks, diagnose based on the International Association of Diabetes and Pregnancy Study Groups (IADPSG) criteria.
Denominator = number of pregnancies (N=31).
NICU: Admission to and stay in the Neonatal Intensive Care Unit or intermediate nursery (Level II) stay of at least 12 hours.
Newborn with low sugar levels that require intravenous glucose therapy.
One of several events occurring during birth, which results in damage to tissues or organs (including clavicular fracture, humerus fracture, skull fracture, brachial plexus injury, facial nerve injury, cephalohematoma and other qualifying traumas). One case of cephalohematoma reported.
Received treatment with supplemental O2 and CPAP or ventilator during the first 72 hours of life.
Abbreviations: GA, gestational age; CPAP, continuous positive airway pressure.