BackgroundPostpartum haemorrhage remains an important cause of maternal death despite treatment with conventional therapy. Uncontrolled studies and one randomised comparison with conventional oxytocics have reported dramatic effects with high-dose misoprostol, usually given rectally, for treatment of postpartum haemorrhage, but this has not been evaluated in a placebo-controlled trial.MethodsThe study was conducted at East London Hospital Complex, Tembisa and Chris Hani Baragwanath Hospitals, South Africa. Routine active management of the third stage of labour was practised. Women with more than usual postpartum bleeding thought to be related to inadequate uterine contraction were invited to participate, and to sign informed consent. All routine treatment was given from a special 'Postpartum Haemorrhage Trolley'. In addition, participants who consented were enrolled by drawing the next in a series of randomised treatment packs containing either misoprostol 5 × 200 μg or similar placebo, which were given 1 orally, 2 sublingually and 2 rectally.ResultsWith misoprostol there was a trend to reduced blood loss ≥500 ml in 1 hour after enrolment measured in a flat plastic 'fracture bedpan', the primary outcome (6/117 vs 11/120, relative risk 0.56; 95% confidence interval 0.21 to 1.46). There was no difference in mean blood loss or haemoglobin level on day 1 after birth < 6 g/dl or blood transfusion. Side-effects were increased, namely shivering (63/116 vs 30/118; 2.14, 1.50 to 3.04) and pyrexia > 38.5°C (11/114 vs 2/118; 5.69, 1.29 to 25). In the misoprostol group 3 women underwent hysterectomy of whom 1 died, and there were 2 further maternal deaths.ConclusionsBecause of a lower than expected incidence of the primary outcome in the placebo group, the study was underpowered. We could not confirm the dramatic effect of misoprostol reported in several unblinded studies, but the results do not exclude a clinically important effect. Larger studies are needed to assess substantive outcomes and risks before misoprostol enters routine use.
An effect of calcium supplementation in the second half of pregnancy on the rate of abnormal laboratory measures associated with preeclampsia was not demonstrated.
IntroductionCancer contributes to a significant proportion of morbidity and mortality globally. Low-income and middle-income countries such as South Africa tend to be characterised by poor and inequitable access to cancer services. Cancer resources are more likely to be found in urban areas, tertiary centres and quaternary hospitals. However, little is known about the linkages to care, continuity of care and packages of cancer care in rural South African settings. This study describes cancer service delivery for South Africa’s Eastern Cape and Mpumalanga provinces.Methods and analysisA mixed-methods qualitative and quantitative research methods of three substudies which include semistructured interviews with patients, focus group discussions with health providers and a quantitative record review that will be carried out at both Rob Ferreira hospital, Witbank hospital and Nelson Mandela Academic hospital in Mpumalanga and Eastern Cape province, respectively. Instruments assess demographic characteristics, explore packages of cancer care, explore challenges experienced by health professionals, and maps out the referral pathway of patients with a cancer diagnosis in the study sites. Numerical, quantitative data will be explored for normality using the Shapiro-Wilk test and reported using either the mean, SD and range or the median and IQR depending on the normality of the distribution. Qualitative data will be analysed using the phenomenological approach.Ethics and disseminationEthics approval was obtained from the Human Research Ethics Committee of Walter Sisulu University (040/2020) and the University of the Witwatersrand (M210211), South Africa. To the research team’s knowledge, this is the first study presenting the model of cancer delivery in South Africa’s Eastern Cape and Mpumalanga province. This will thus provide better understanding of cancer service delivery systems, packages of cancer care from primary care to quaternary care.
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