Performance of a validated spontaneous preterm delivery predictor in South Asian and Sub-Saharan African women: a nested case control study.

OBJECTIVES: To address the disproportionate burden of preterm birth (PTB) in low- and middle-income countries, this study aimed to (1) verify the performance of the United States-validated spontaneous PTB (sPTB) predictor, comprised of the IBP4/SHBG protein ratio, in subjects from Bangladesh, Pakistan and Tanzania enrolled in the Alliance for Maternal and Newborn Health Improvement (AMANHI) biorepository study, and (2) discover biomarkers that improve performance of IBP4/SHBG in the AMANHI cohort. STUDY DESIGN: The performance of the IBP4/SHBG biomarker was first evaluated in a nested case control validation study, then utilized in a follow-on discovery study performed on the same samples. Levels of serum proteins were measured by targeted mass spectrometry. Differences between the AMANHI and U.S. cohorts were adjusted using body mass index (BMI) and gestational age (GA) at blood draw as covariates. Prediction of sPTB < 37 weeks and < 34 weeks was assessed by area under the receiver operator curve (AUC). In the discovery phase, an artificial intelligence method selected additional protein biomarkers complementary to IBP4/SHBG in the AMANHI cohort. RESULTS: The IBP4/SHBG biomarker significantly predicted sPTB < 37 weeks (n = 88 vs. 171 terms ≥ 37 weeks) after adjusting for BMI and GA at blood draw (AUC= 0.64, 95% CI: 0.57-0.71, p < .001). Performance was similar for sPTB < 34 weeks (n = 17 vs. 184 ≥ 34 weeks): AUC = 0.66, 95% CI: 0.51-0.82, p = .012. The discovery phase of the study showed that the addition of endoglin, prolactin, and tetranectin to the above model resulted in the prediction of sPTB < 37 with an AUC= 0.72 (95% CI: 0.66-0.79, p-value < .001) and prediction of sPTB < 34 with an AUC of 0.78 (95% CI: 0.67-0.90, p < .001). CONCLUSION: A protein biomarker pair developed in the U.S. may have broader application in diverse non-U.S. populations.

Effect of a package of integrated demand- and supply-side interventions on facility delivery rates in rural Bangladesh: Implications for large-scale programs.

BACKGROUND: According to the Bangladesh Demographic and Health Survey 2014, only approximately 37 percent of women deliver in a health facility. Among the eight administrative divisions of Bangladesh, the facility delivery rate is lowest in the Sylhet division (22.6 percent) where we assessed the effect of integrated supply- and demand-side interventions on the facility-based delivery rate. METHODS: Population-based cohort data of pregnant women from an ongoing maternal and newborn health improvement study being conducted in a population of ~120,000 in Sylhet district were used. The study required collection and processing of biological samples immediately after delivery. Therefore, the project assembled various strategies to increase institutional delivery rates. The supply-side intervention included capacity expansion of the health facilities through service provider refresher training, 24/7 service coverage, additions of drugs and supplies, and incentives to the providers. The demand-side component involved financial incentives to cover expenses, a provision of emergency transport, and referral support to a tertiary-level hospital. We conducted a before-and-after observational study to assess the impact of the intervention in a total of 1,861 deliveries between December 2014 and November 2016. RESULTS: Overall, implementation of the intervention package was associated with 52.6 percentage point increase in the proportions of facility-based deliveries from a baseline rate of 25.0 percent to 77.6 percent in 24 months. We observed lower rates of institutional deliveries when only supply-side interventions were implemented. The proportion rose to 47.1 percent and continued increasing when the project emphasized addressing the financial barriers to accessing obstetric care in a health facility. CONCLUSIONS: An integrated supply- and demand-side intervention was associated with a substantial increase in institutional delivery. The package can be tailored to identify which combination of interventions may produce the optimum result and be scaled. Rigorous implementation research studies are needed to draw confident conclusions and to provide information about the costs, feasibility for scale-up and sustainability.