Early pregnancy HbA1c as the first screening test for gestational diabetes: results from three prospective cohorts.

BACKGROUND: More than 90% of gestational diabetes cases are estimated to occur in low-income and middle-income countries (LMICs). Most current guidelines recommend an oral glucose tolerance test (OGTT) at 24-28 weeks of gestation. The OGTT is burdensome, especially in LMICs, resulting in a high proportion of women not being screened. We aimed to develop a simple and effective screening strategy for gestational diabetes. METHODS: STRiDE, a prospective cohort study, was set up in seven centres in south India and seven centres in western Kenya, and included pregnant women aged 18-50 years of age and at less than 16 weeks of gestation (<20 weeks in Kenya), confirmed by dating ultrasound. We assessed the efficacy of early pregnancy HbA1c (venous and capillary point-of-care), either alone or as part of a composite risk score with age, BMI, and family history of diabetes, in predicting gestational diabetes at 24-28 weeks of gestation, in two LMICs (India and Kenya) and in a UK multi-ethnic population from the PRiDE study. A key secondary outcome was to assess whether an early pregnancy composite risk score can reduce the need for OGTTs. Gestational diabetes was diagnosed using current WHO criteria. FINDINGS: Between Feb 15, 2016, Dec 13, 2019, we enrolled 3070 participants in India and 4104 in Kenya. 4320 participants were included from the PRiDE cohort. Gestational diabetes prevalence by OGTT at 24-28 weeks was 19·2% in India, 3·0% in Kenya, and 14·5% in the UK. Early pregnancy HbA1c was independently associated with incidence of gestational diabetes at 24-28 weeks of gestation. Adjusted risk ratios were 1·60 (95% CI 1·19-2·16) in India, 3·49 (2·8-4·34) in Kenya, and 4·72 (3·82-5·82) in the UK. Composite risk score models that combined venous or point-of-care HbA1c with age, BMI, and family history of diabetes best predicted testing positive for gestational diabetes. A population-specific, two-threshold screening strategy of rule-in and rule-out gestational diabetes using early pregnancy composite risk score could reduce the requirement of OGTTs by 50-64%. For the HbA1c-alone model, the thresholds were 5·4% (rule in) and 4·9% (rule out) in India, 6·0% (rule in) and 5·2% (rule out) in Kenya, and 5·6% (rule in) and 5·2% (rule out) in the UK. INTERPRETATION: Early pregnancy HbA1c offers a simple screening test for gestational diabetes, allowing those at highest risk to receive early intervention and greatly reduce the need for OGTTs. This can also be carried out using point-of-care HbA1c in LMICs. FUNDING: UK Medical Research Council and the Indian Department of Biotechnology.

COHESION: a core outcome set for the treatment of neonatal encephalopathy.

BACKGROUND: Heterogeneity in outcomes reported in trials of interventions for the treatment of neonatal encephalopathy (NE) makes evaluating the effectiveness of treatments difficult. Developing a core outcome set for NE treatment would enable researchers to measure and report the same outcomes in future trials. This would minimise waste, ensure relevant outcomes are measured and enable evidence synthesis. Therefore, we aimed to develop a core outcome set for treating NE. METHODS: Outcomes identified from a systematic review of the literature and interviews with parents were prioritised by stakeholders (n = 99 parents/caregivers, n = 101 healthcare providers, and n = 22 researchers/ academics) in online Delphi surveys. Agreement on the outcomes was achieved at online consensus meetings attended by n = 10 parents, n = 18 healthcare providers, and n = 13 researchers/ academics. RESULTS: Seven outcomes were included in the final core outcome set: survival; brain injury on imaging; neurological status at discharge; cerebral palsy; general cognitive ability; quality of life of the child, and adverse events related to treatment. CONCLUSION: We developed a core outcome set for the treatment of NE. This will allow future trials to measure and report the same outcomes and ensure results can be compared. Future work should identify how best to measure the COS. IMPACT: We have identified seven outcomes that should be measured and reported in all studies for the treatment of neonatal encephalopathy. Previously, a core outcome set for neonatal encephalopathy treatments did not exist. This will help to reduce heterogeneity in outcomes reported in clinical trials and other studies, and help researchers identify the best treatments for neonatal encephalopathy.

Impact of free maternity services on outcomes related to hypertensive disorders of pregnancy at Moi Teaching and Referral Hospital in Kenya: a retrospective analysis.

BACKGROUND: Preeclampsia is a major contributor to maternal and neonatal mortality worldwide. Ninety-nine percent of these deaths occur in resource limited settings. One of the greatest barriers to women seeking medical attention remains the cost of care. Kenya implemented a nation-wide policy change in 2013, offering free inpatient maternity services to all women to address this concern. Here, we explore the impact of this policy change on maternal and neonatal outcomes specific to the hypertensive disorders of pregnancy. METHODS: We conducted a retrospective cross-sectional chart review of patients discharged or deceased with a diagnosis of gestational hypertension, preeclampsia, eclampsia or HELLP syndrome at a tertiary referral center in western Kenya one year before (June 1, 2012-May 31, 2013) and one year after (June 1, 2013-May 31, 2014) free maternity services were introduced at public facilities across the country. Demographic information, obstetric history, medical history, details of the current pregnancy, diagnosis on admission and at discharge, antepartum treatment, maternal outcomes, and neonatal outcomes were collected and comparisons were made between the time points. RESULTS: There were more in hospital births after policy change was introduced. The proportion of women diagnosed with a hypertensive disorder of pregnancy was higher in the year before free maternity care although there was a statistically significant increase in the proportion of women diagnosed with gestational hypertension after policy change. Among those diagnosed with hypertensive disorders, there was no difference in the proportion who developed obstetric or medical complications. Of concern, there was a statistically significant increase in the proportion of women dying as a result of their condition. There was a statistically significant increase in the use of magnesium sulfate for seizure prophylaxis. There was no overall difference in the use of anti-hypertensives between groups and no overall difference in the proportion of women who received dexamethasone for fetal lung maturity. CONCLUSIONS: Free maternity services, however necessary, are insufficient to improve maternal and neonatal outcomes related to the hypertensive disorders of pregnancy at a tertiary referral center in western Kenya. Multiple complementary strategies acting in unison are urgently needed.

Core outcomes in neonatal encephalopathy: a qualitative study with parents.

OBJECTIVE: To identify the outcomes considered important to parents or caregivers of infants diagnosed with neonatal encephalopathy, hypoxic ischaemic encephalopathy or birth asphyxia in high-income and low- to middle-income countries (LMiCs), as part of the outcome-identification process in developing a core outcome set (COS) for the treatment of neonatal encephalopathy. DESIGN: A qualitative study involving 25 semistructured interviews with parents or other family members (caregivers) of infants who were diagnosed with, and treated for, neonatal encephalopathy, hypoxic ischaemic encephalopathy or birth asphyxia. SETTING: Interviews were conducted in high-income countries (HiCs) (n=11) by Zoom video conferencing software and in LMiCs (n=14) by phone or face to face. FINDINGS: Parents identified 54 outcomes overall, which mapped to 16 outcome domains. The domains identified were neurological outcomes, respiratory outcomes, gastrointestinal outcomes, cardiovascular outcomes, motor development, cognitive development, development (psychosocial), development (special senses), cognitive development, development (speech and social), other organ outcomes, survival/living outcomes, long-term disability, hospitalisation, parent-reported outcomes and adverse events. CONCLUSIONS: This study provides insight into the outcomes that parents of infants diagnosed with neonatal encephalopathy have identified as the most important, to be considered in the process of developing a COS for the treatment of neonatal encephalopathy. We also provide description of the processes employed to ensure the inclusion of participants from LMiCs as well as HiCs.