METHODS: This is a retrospective comparative cohort study design. Two hundred and fifty Malaysian women were part of a previous study examining the prevalence of PND in a multiracial country and the effects of postnatal rituals. All women were at least 6 weeks post-partum when asked to complete the Edinburgh Postnatal Depression Scale (EPDS). Sociodemographic and birth data were obtained.
RESULTS: Data collected were divided into two groups: 55 emergency delivery and 191 non-emergency delivery. There were four missing data. There was no significant difference in the mean age, parity, gestational period, baby birthweight, 5 min baby Apgar score and EPDS scores of the two groups. However, the analysis of PND indicated that women with emergency delivery had a relative risk of 1.81 compared with women with non-emergency delivery. The comparison of the two groups using chi2 indicated a significant (chi2 = 3.94, d.f. = 1, P = 0.04) increase in the presence of PND in the emergency delivery.
CONCLUSION: When compared with women having non-emergency delivery, women having emergency delivery had about twice the risk of developing PND. Special attention to this group appears warranted.
RECOMMENDATIONS: This is a narrative opinion piece on the design of clinical trials in youth-onset type 2 diabetes prepared by researchers who undertake this type of study in different countries. The review addresses possible ways to enhance trial designs in youth-onset type 2 diabetes to meet regulatory requirements, while minimizing the barriers to patients' participation. The definition of adolescence, recruitment of sufficient patient numbers, increasing flexibility in selection criteria, improving convenience of trial visits, requirements of a control group, possible endpoints, and trial compliance are all considered. The authors recommend allowing extrapolation from adult data, using multiple interventional arms within future trials, broadening inclusion criteria, and focusing on endpoints beyond glucose control, among others, in order to improve the successful completion of more trials in this population.
CONCLUSIONS: Improvements in trial design will enable better recruitment and retention and thereby more evidence for treatment outcomes for youth-onset type 2 diabetes.