The impact of implementing the 2016 WHO Recommendations on Antenatal Care for a Positive Pregnancy Experience on perinatal deaths: An interrupted time-series analysis in Mpumalanga province, South Africa

Objectives To investigate if the implementation of the 2016 WHO Recommendations for a Positive Pregnancy Experience reduced perinatal mortality in a South African province. The recommendations were implemented which included increasing the number of contacts and also the content of the contacts. Methods Retrospective interrupted time-series analysis was conducted for all women accessing a minimum of one antenatal care contact from April 2014 to September 2019 in Mpumalanga province, South Africa. Retrospective interrupted time-series analysis of province level perinatal mortality and birth data comparing the pre-implementation period (April 2014-March 2017) and post-implementation period (April 2018-September 2019). The main outcome measure was unadjusted prevalence ratio (PR) for perinatal deaths before and after implementation; interrupted time-series analyses for trends in perinatal mortality before and after implementation; stillbirth risk by gestational age; primary cause of deaths (and maternal condition) before and after implementation. Results Overall, there was a 5.8% absolute decrease in stillbirths after implementation of the recommendations, however this was not statistically significant (PR 0.95, 95% CI 0.90% to 1.05%; p=0.073). Fresh stillbirths decreased by 16.6% (PR 0.86, 95% CI 0.77% to 0.95%; p=0.003) while macerated stillbirths (p=0.899) and early neonatal deaths remained unchanged (p=0.499). When stratified by weight fresh stillbirths >2500 g decreased by 17.2% (PR 0.81, 95% CI 0.70% to 0.94%; p=0.007) and early neonatal deaths decreased by 12.8% (PR 0.88, 95% CI 0.77% to 0.99%; p=0.041). The interrupted time-series analysis confirmed a trend for decreasing stillbirths at 0.09/1000 births per month (-0.09, 95% CI-1.18 to 0.01; p=0.059), early neonatal deaths (-0.09, 95% CI-0.14 to 0.04; p=<0.001) and perinatal mortality (-1.18, 95% CI-0.27 to-0.09; p<0.001) in the post-implementation period. A decrease in stillbirths, early neonatal deaths or perinatal mortality was not observed in the pre-implementation period. During the period when additional antenatal care contacts were implemented (34-38 weeks), there was a decrease in stillbirths of 18.4% (risk ratio (RR) 0.82, 95% CI 0.73% to 0.91%, p=0.0003). In hypertensive disorders of pregnancy, the risk of stillbirth decreased in the post-period by 15.1% (RR 0.85; 95% CI 0.76% to 0.94%; p=0.002). Conclusion The implementation of the 2016 WHO Recommendations for a Positive Pregnancy Experience may be an effective public health strategy to reduce stillbirths in South African provinces. An interrupted time-series study design was conducted using province-level perinatal mortality data from the Perinatal Problem Identification Program (PPIP). Mandatory reporting of all perinatal deaths including primary cause of death is required in South Africa. PPIP captures births and deaths in all public health facilities from primary level through to tertiary level. Mpumalanga province was chosen for this analysis as it is the province with the most rigorous auditing of maternal and perinatal deaths. The 2016 WHO Recommendations on a Positive Pregnancy Experience were implemented from 1st of April 2017. We allowed for a 12-month implementation period between 1st of April 2017 and 31st of March 2018, based on the rationale that it would take approximately 6 months to upscale the intervention across the province and an additional 6 months for the first women accessing ANC to begin delivering their infants. The pre-period was 1st of April 2014 to 31st of March 2017 (36 months) and the post-period was 1st of April 2018 to 30th of September 2019 (18 months). We evaluated stillbirths and early neonatal deaths (>1000 g) in women who had accessed any ANC, before and after the implementation period. We also examined stillbirth risk across pregnancy, primary cause of death and maternal condition before and after implementation. After some unease was expressed by South African clinicians using the reduced antenatal contact model,13 a working group was established by the National Department of Health (NDoH) to review ANC in South Africa. The working group’s report was submitted to the NDoH and was supported by the release of the WHO Recommendations. The Minister of Health accepted a new ANC package (called Basic Antenatal Care Plus—BANC Plus) put forward at the National Health Council on 24th of November 2016 and instructed the members of the executive council to implement BANC Plus starting 1st of April 2017. BANC Plus supported the WHO recommendation to increase routine ANC contacts for all women to >12, 20, 26, 30, 34, 36, 38, 40 weeks. Prior to the implementation of BANC Plus, the routine ANC schedule across South Africa consisted of five contacts at 20, 26, 32, 38, 41 weeks (except Western Cape which had more frequent contacts). The South African Medical Research Council Maternal and Infant Health Care Strategies unit played an integral role in adapting the recommendations for the South African clinical context.14 In addition to the increase in the number of contacts, the content of each contact was changed. The antenatal checklist to be completed after every contact was adapted so that the examinations, investigations and interventions that needed to be done at the contact were listed. Introducing BANC Plus was about changing the way ANC was carried out. In South Africa women access ANC at the primary health clinic (PHC) level and are up-referred if they are identified as high risk using a predefined set of criteria including conditions such as fetal growth restriction and hypertension. One of the intended focus points was to increase the detection and management of hypertension which is the leading cause of direct maternal mortality and responsible for a large proportion of perinatal deaths in South Africa (accounting for 14.8% of all maternal deaths and ~19% of perinatal deaths).12 15 The BANC Plus Guidelines and WHO Recommendations for a Positive Pregnancy Experience can be viewed in full here.5 During the month of April 2017, the demand for ANC was generated by radio adverts to promote the increased number of antenatal contacts, women on the MomConnect app were informed of the new contacts and all women currently accessing ANC given the new information. Supply was catered for by workshops being held in every district in South Africa explaining the new package and information was sent to midwives on their social media forum. There were no additional human resources needed and the only extra resource was printing the new antenatal checklists, so the costs were minimal. South Africa has an extensive network of primary care clinics, and they are not busy all of the time often in the afternoons there are no patients to be seen, so there was capacity to manage the extra contacts. BANC Plus workshops were held in the three districts of Mpumalanga in February and March 2017 with doctors and midwives from the hospitals and primary care clinics attending. At-scale implementation started on 1st of April 2017. A subanalysis of four catchment areas across South Africa (Springs, Upington, Mafikeng and Thohoyandou) between March 2017 (beginning of at-scale implementation) and March 2018 (after transition) showed an increase in the proportion of women who had accessed six contacts or more (from 36.5% to 61.0%) and women who accessed eight contacts or more (from 4.6% to 24.5%).16 Province-level data were extracted for each month during the study period for livebirths (birth weight (g), mother attended ANC (y/n), maternal condition) and perinatal deaths (birth weight (g), gestational age at birth (weeks), mother attended ANC (y/n), primary cause of death, maternal condition). Maternal condition was classified as: healthy mother, coincidental conditions, medical/surgical disorders, non-pregnancy-related infections, extrauterine pregnancy, pregnancy-related sepsis, obstetric haemorrhage, hypertension. Descriptive analyses were performed to compare stillbirth and early neonatal death period prevalence in the pre-implementation and post-implementation period as well as cause of death (including maternal condition). In addition, the number of stillbirths (fresh, macerated), early neonatal deaths (0–7 days) and perinatal death were calculated per 1000 births for each month of the study period. Interrupted time-series analyses (ordinary least square regression) with Newey-West SEs were used to examine trends in perinatal deaths, stillbirths and early neonatal deaths before and after implementation. Six months post-implementation of the guidelines was used as the start of the post-implementation period to allow women becoming pregnant under the new recommendations to give birth. Interrupted time-series analyses are useful when population-level outcomes (eg, deaths per 1000 births) are calculated over time with statistical regression modelling used to examine how trends in outcomes are impacted by a population-level exposure occurring in a well-defined period (in this case, implementation of the 2016 WHO Recommendations for a Positive Pregnancy Experience/BANC Plus on 1st of April 2017).17 In this way, any disruptions to the underlying trends in the outcome over time can be examined. Three assumptions were confirmed prior to conducting the interrupted time-series analyses including (a) the pre-trend was linear (examined visually), (b) characteristics of the study population remain unchanged over the study period, (c) there is no comparator against which to adjust the results for changes that should not be attributed to the intervention.17 The analyses were conducted using StataMP V.15, making use of the ITSA command for the interrupted time-series analysis. Stillbirth risk across pregnancy was compared before and after implementation using Yudkin’s method of stillbirth risk calculation (known at the fetuses-at-risk approach) as in our previous analyses.8 18 This approach considers the number of fetuses still in-utero as the population at risk. There was no information available on the gestational age of livebirths for all women across Mpumalanga province. Therefore, gestational age at birth for livebirths in one subdistrict (Mamelodi subdistrict) was used to estimate the number of livebirths at each gestational age across Mpumalanga province. (1) The proportion of live births in each birth weight category (500–999 g; 1000–1499 g; 1500–1999 g; 2000–2499 g; ≥2500 g) for Mpumalanga was compared with the proportion of live births in each birth weight category for Mamelodi. There were no significant differences in the proportion of live births occurring in each birth weight category between Mpumalanga and Mamelodi. (2) The distribution of live births across gestation from Mamelodi was plotted, that is, the proportion of all live births for Mamelodi that occurred at each gestational age (eg, at 26 weeks 0.49% of infants were born, at 38 weeks 17.67% of infants were born). (3) The proportion of live births at each gestational age in Mamelodi was applied to the number of known births in Mpumalanga (eg, at 26 weeks 0.49% of infants were born, at 38 weeks 17.67% of infants were born). (4) Sensitivity analysis was conducted as outlined below. At each gestational age stillbirth risk was calculated using the number of stillbirths (as the numerator) divided by the total number of unborn fetuses and expressed as the number of stillbirths per 1000 fetuses still in-utero. No patients were involved in setting the research question or the outcome measures, nor were they involved in developing plans for design or implementation of the study. No patients were asked to advise on interpretation or writing up of results.