METHODOLOGY: This was a prospective cohort study. Shortly after birth, cranial ultrasonography was carried out via the anterior fontanelles of 70 normal control infants and 104 asphyxiated infants with a history of fetal distress and Apgar scores of less than 6 at 1 and 5 min of life, or requiring endotracheal intubation and manual intermittent positive pressure ventilation for at least 5 min after birth. Neurodevelopmental assessment was carried out on the survivors at 1 year of age.
RESULTS: Abnormal cranial ultrasound changes were detected in a significantly higher proportion (79.8%, or n = 83) of asphyxiated infants than controls (39.5%, or n = 30) (P < 0.0001). However, logistic regression analysis showed that only three factors were significantly associated with adverse outcome at 1 year of life among the asphyxiated infants. These were: (i) decreasing birthweight (for every additional gram of increase in birthweight, adjusted odds ratio (OR) = 0.999, 95% confidence interval (CI) 0.998, 1.000; P = 0.047); (ii) a history of receiving ventilatory support during the neonatal period (adjusted OR = 8.3; 95%CI 2.4, 28.9; P = 0.0009); and (iii) hypoxic-ischaemic encephalopathy stage 2 or 3 (adjusted OR = 5.8; 95%CI 1.8, 18.6; P = 0.003). None of the early cranial ultrasound changes was a significant predictor.
CONCLUSIONS: Early cranial ultrasound findings, although common in asphyxiated infants, were not significant predictors of adverse outcome during the first year of life in asphyxiated term infants.
METHODS: We conducted a multicentre randomised controlled study of 420 patients from 1st January 2016 to 31st December 2017 to evaluate the use of DBC in IOL in an Asian population looking at the adverse effects in the first 12 h after insertion. Women were assigned randomly to cervical ripening with either a DBC or a prostaglandin pessary. The adverse events in the 12 h after DBC or first prostaglandin inserted, the efficacy of a DBC to a prostaglandin in labour induction and maternal satisfaction were evaluated.
RESULTS: There were significantly less women with uterine hyperstimulation in the DBC (2 vs 24, p ≤ 0.0001) compared to the prostaglandin group. There were no women with uterine hyperstimulation and non-reassuring foetal status in the DBC while there were 5 women with uterine hyperstimulation and foetal distress in the prostaglandin group. Use of entonox was significantly less in the DBC group (p = 0.009). There were no significant differences in both groups in caesarean section, vaginal deliveries and time to delivery, although significant less time was needed to achieve cervical os dilation more than 4 cm in the DBC group (p ≤ 0.0001). Neonatal birth outcomes were similar. Women's pain scores were similar for both methods. 80.1% of women allocated the DBC and 76.8% of women allocated the PGE were keen to recommend their method of induction.
CONCLUSION: Double balloon catheter remains a good alternative method for inducing women in view of a good safety profile with low risk of hyperstimulation and high maternal satisfaction.
CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02620215.
METHODS: A double blind randomized trial. 103 women scheduled to receive two doses of 12-mg intramuscular dexamethasone 12-hour apart were separately randomized to take prophylactic metformin or placebo after stratification according to their gestational diabetes (GDM) status. First oral dose of allocated study drug was taken at enrolment and continued 500 mg twice daily for 72 hours if not delivered. Six-point blood sugar profiles were obtained each day (pre- and two-hour post breakfast, lunch and dinner) for up to three consecutive days. A hyperglycemic episode is defined as capillary glucose fasting/pre-meal ≥ 5.3 mmol/L or two-hour post prandial/meal ≥ 6.7 mmol/L. Primary outcome was hyperglycemic episodes on Day-1 (first six blood sugar profile points) following antenatal corticosteroids.
RESULTS: Number of hyperglycemic episodes on the first day were not significantly different (mean ± standard deviation) 3.9 ± 1.4 (metformin) vs. 4.1 ± 1.6 (placebo) p = 0.64. Hyperglycemic episodes markedly reduced on second day in both arms to 0.9 ± 1.0 (metformin) vs. 1.2 ± 1.0 (placebo) p = 0.15 and further reduced to 0.6 ± 1.0 (metformin) vs. 0.7 ± 1.0 (placebo) p = 0.67 on third day. Hypoglycemic episodes during the 3-day study period were few and all other secondary outcomes were not significantly different.
CONCLUSIONS: In euglycemic and diet controllable gestational diabetes mellitus women, antenatal corticosteroids cause sustained maternal hyperglycemia only on Day-1. The magnitude of Day-1 hyperglycemia is generally low. Prophylactic metformin does not reduce antenatal corticosteroids' hyperglycemic effect.
TRIAL REGISTRATION: The trial is registered in the ISRCTN registry on May 4 2017 with trial identifier https://doi.org/10.1186/ISRCTN10156101 .