Planned delivery or expectant management for late preterm pre-eclampsia in low-income and middle-income countries (CRADLE-4): a multicentre, open-label, randomised controlled trial.

BACKGROUND: Pre-eclampsia is a leading cause of maternal and perinatal mortality. Evidence regarding interventions in a low-income or middle-income setting is scarce. We aimed to evaluate whether planned delivery between 34+ 0 and 36+ 6 weeks' gestation can reduce maternal mortality and morbidity without increasing perinatal complications in India and Zambia. METHODS: In this parallel-group, multicentre, open-label, randomised controlled trial, we compared planned delivery versus expectant management in women with pre-eclampsia from 34+ 0 to 36+ 6 weeks' gestation. Participants were recruited from nine hospitals and referral facilities in India and Zambia and randomly assigned to planned delivery or expectant management in a 1:1 ratio by a secure web-based randomisation facility hosted by MedSciNet. Randomisation was stratified by centre and minimised by parity, single-fetus pregnancy or multi-fetal pregnancy, and gestational age. The primary maternal outcome was a composite of maternal mortality or morbidity with a superiority hypothesis. The primary perinatal outcome was a composite of one or more of: stillbirth, neonatal death, or neonatal unit admission of more than 48 h with a non-inferiority hypothesis (margin of 10% difference). Analyses were by intention to treat, with an additional per-protocol analysis for the perinatal outcome. The trial was prospectively registered with ISRCTN, 10672137. The trial is closed to recruitment and all follow-up has been completed. FINDINGS: Between Dec 19, 2019, and March 31, 2022, 565 women were enrolled. 284 women (282 women and 301 babies analysed) were allocated to planned delivery and 281 women (280 women and 300 babies analysed) were allocated to expectant management. The incidence of the primary maternal outcome was not significantly different in the planned delivery group (154 [55%]) compared with the expectant management group (168 [60%]; adjusted risk ratio [RR] 0·91, 95% CI 0·79 to 1·05). The incidence of the primary perinatal outcome by intention to treat was non-inferior in the planned delivery group (58 [19%]) compared with the expectant management group (67 [22%]; adjusted risk difference -3·39%, 90% CI -8·67 to 1·90; non-inferiority p<0·0001). The results from the per-protocol analysis were similar. There was a significant reduction in severe maternal hypertension (adjusted RR 0·83, 95% CI 0·70 to 0·99) and stillbirth (0·25, 0·07 to 0·87) associated with planned delivery. There were 12 serious adverse events in the planned delivery group and 21 in the expectant management group. INTERPRETATION: Clinicians can safely offer planned delivery to women with late preterm pre-eclampsia, in a low-income or middle-income country. Planned delivery reduces stillbirth, with no increase in neonatal unit admissions or neonatal morbidity and reduces the risk of severe maternal hypertension. Planned delivery from 34 weeks' gestation should therefore be considered as an intervention to reduce pre-eclampsia associated mortality and morbidity in these settings. FUNDING: UK Medical Research Council and Indian Department of Biotechnology.

Post-abortion care services in Zambian health facilities: a qualitative study of users' experiences and perceptions.

BACKGROUND: Despite attempts to increase Universal Health Coverage, availability, accessibility, acceptability, and quality-related challenges remain barriers to receiving essential services by women who need them. We aimed to explore the experiences and perceptions of women receiving post-abortal care services in Zambia, within a human-rights framework. METHODS: A qualitative case study was conducted between August and September 2021 in Lusaka and Copperbelt provinces of Zambia. Fifteen (15) women seeking post-abortion care services were` interviewed using audio recorders; transcribed data was analyzed using thematic analysis. We report women's experiences and perceptions of the healthcare system, their experiences of abortion, and healthcare-seeking behaviour. We used the availability, accessibility, acceptability, and quality (AAAQ) framework to understand how women claimed their right to healthcare as they sought and utilized post-abortion care services. RESULTS: Women who experienced spontaneous abortions delayed seeking health care by viewing symptoms as 'normal pregnancy symptoms' and not dangerous. Women also delayed seeking care because they feared the negative attitudes from their communities and the health care providers towards abortion in general, despite it being legal in Zambia. Some services were considered costly, impeding their right to access quality care. CONCLUSIONS: Women delayed seeking care compounded by fear of negative attitudes from the community and healthcare providers. To ensure the provision and utilization of quality all abortion-related healthcare services, there is a need to increase awareness of the availability and legality of safe abortion services, the importance of seeking healthcare early for any abortion-related discomfort, and the provision and availability of free services at all levels of care should be emphasized.

Unsafe abortions continue to be an avoidable public health concern both globally and locally. In Zambia, a fifth of maternal deaths are related to unsafe abortions. Unsafe abortions have been defined as any induced termination of pregnancy outside the health facility, performed by untrained health personnel. Several strides have been made including the provision of comprehensive abortion care in all facilities, and the training of health personnel to provide these services at different levels of healthcare. Despite the increased availability of comprehensive abortion care through liberalized abortion laws and regulations and the training of health personnel to provide these services at different levels of healthcare, the need for quality post-abortion care specifically persists. As such, we carried out in-depth interviews to explore the experiences of women who present at healthcare facilities in Lusaka and the Copperbelt provinces in Zambia seeking post-abortion services. It was found that delay in seeking care at a health facility was due to fear that the service is illegal; alongside judgment from health care providers and society for seeking such a service that is generally perceived as evil. The assumption that the cost of receiving such services is high and a general lack of awareness about the service being provided free was also expressed. The study highlighted the need for community awareness of the legal framework on abortions to ensure women access services at any time necessary without fear of being judged, which will consequently reduce the number of abortion-related disabilities and deaths.