Tranexamic acid at cesarean delivery: Drug-error deaths.

The use of tranexamic acid for postpartum hemorrhage has entered obstetrical practice globally with the evidence-based expectation of saving lives. This improvement in the care of women with postpartum hemorrhage has come at a price. For the anesthetist, having tranexamic acid ampoules close at hand would seem an obvious strategy to facilitate its use during cesarean delivery, an important setting for severe hemorrhage. Tragically, we have identified a number of recent instances of inadvertent intrathecal administration of tranexamic acid instead of local anesthetic for spinal anesthesia. Reported cases of this catastrophic error seem to be increasing. The profound neurotoxicity of tranexamic acid causes rapid-onset convulsions, with mortality of 50%. How can these tragic errors be averted? Drug safety alerts have been issued by the US Food and Drug Administration and the World Health Organization, but that is not enough. We recommend extensive dissemination of information to raise awareness of this potential hazard, and local hospital protocols to ensure that tranexamic acid is stored separately from anesthetic drugs, preferably outside the operating room and with an auxiliary warning label. Implementation of safety strategies on a very large scale will be needed to ensure that the life-saving potential of tranexamic acid is not eclipsed by drug-error mortality.

Tranexamic acid at cesarean delivery: drug-error deaths.

The use of tranexamic acid for postpartum hemorrhage has entered obstetrical practice globally with the evidence-based expectation of saving lives. This improvement in the care of women with postpartum hemorrhage has come at a price. For the anesthetist, having tranexamic acid ampoules close at hand would seem an obvious strategy to facilitate its use during cesarean delivery, an important setting for severe hemorrhage. Tragically, we have identified a number of recent instances of inadvertent intrathecal administration of tranexamic acid instead of local anesthetic for spinal anesthesia. Reported cases of this catastrophic error seem to be increasing. The profound neurotoxicity of tranexamic acid causes rapid-onset convulsions, with mortality of 50%. How can these tragic errors be averted? Drug safety alerts have been issued by the US Food and Drug Administration and the World Health Organization, but that is not enough. We recommend extensive dissemination of information to raise awareness of this potential hazard, and local hospital protocols to ensure that tranexamic acid is stored separately from anesthetic drugs, preferably outside the operating room and with an auxiliary warning label. Implementation of safety strategies on a very large scale will be needed to ensure that the life-saving potential of tranexamic acid is not eclipsed by drug-error mortality.

Tranexamic acid at cesarean delivery: drug-error deaths.

The use of tranexamic acid for postpartum hemorrhage has entered obstetrical practice globally with the evidence-based expectation of saving lives. This improvement in the care of women with postpartum hemorrhage has come at a price. For the anesthetist, having tranexamic acid ampoules close at hand would seem an obvious strategy to facilitate its use during cesarean delivery, an important setting for severe hemorrhage. Tragically, we have identified a number of recent instances of inadvertent intrathecal administration of tranexamic acid instead of local anesthetic for spinal anesthesia. Reported cases of this catastrophic error seem to be increasing. The profound neurotoxicity of tranexamic acid causes rapid-onset convulsions, with mortality of 50%. How can these tragic errors be averted? Drug safety alerts have been issued by the US Food and Drug Administration and the World Health Organization, but that is not enough. We recommend extensive dissemination of information to raise awareness of this potential hazard, and local hospital protocols to ensure that tranexamic acid is stored separately from anesthetic drugs, preferably outside the operating room and with an auxiliary warning label. Implementation of safety strategies on a very large scale will be needed to ensure that the life-saving potential of tranexamic acid is not eclipsed by drug-error mortality.

Tranexamic acid at cesarean delivery: drug-error deaths.

The use of tranexamic acid for postpartum hemorrhage has entered obstetrical practice globally with the evidence-based expectation of saving lives. This improvement in the care of women with postpartum hemorrhage has come at a price. For the anesthetist, having tranexamic acid ampoules close at hand would seem an obvious strategy to facilitate its use during cesarean delivery, an important setting for severe hemorrhage. Tragically, we have identified a number of recent instances of inadvertent intrathecal administration of tranexamic acid instead of local anesthetic for spinal anesthesia. Reported cases of this catastrophic error seem to be increasing. The profound neurotoxicity of tranexamic acid causes rapid-onset convulsions, with mortality of 50%. How can these tragic errors be averted? Drug safety alerts have been issued by the US Food and Drug Administration and the World Health Organization, but that is not enough. We recommend extensive dissemination of information to raise awareness of this potential hazard, and local hospital protocols to ensure that tranexamic acid is stored separately from anesthetic drugs, preferably outside the operating room and with an auxiliary warning label. Implementation of safety strategies on a very large scale will be needed to ensure that the life-saving potential of tranexamic acid is not eclipsed by drug-error mortality.

Preference for mode of delivery in a low-risk population in Cape Town, South Africa.

OBJECTIVES: There has been an increase in Caesarean section rates in many developed countries with maternal request frequently being cited as a reason. There are few studies examining African women's preference for mode of delivery. The objectives this study were to determine women's preference for mode of delivery in a low risk population to describe the major reasons for their preferences. STUDY DESIGN: Women over the age of 18 with a singleton low risk pregnancy were recruited during the third trimester. Two trained interviewers conducted a questionnaire in the women's preferred language regarding her preference for mode of delivery. RESULTS: Of the 195 women that participated, 160 (82.1 %) indicated a preference for vaginal delivery, 5 (2.6 %) preferred a Caesarean delivery, and 30 women (15.4 %) were unsure about their preferred mode of delivery. There was a significant association between delivery preference and age, ethnicity and HIV status. Level of education, employment, income, relationship status, and parity demonstrated no statistical association. In addition, 106 (54.4 %) did not believe that women should be given the right to request a Caesarean section. CONCLUSION: The majority of women prefer to have a vaginal delivery. In this low risk population, 15.4 % of women were unsure about their preference.

Management of the third stage of labour: (for the Optimal Intrapartum Care series edited by Mercedes Bonet, Femi Oladapo and Metin Gülmezoglu).

The physiology of the third stage of labour is described. Active management reduces the risk of postpartum haemorrhage (PPH), due to the use of a uterotonic agent. Intramuscular Oxytocin 10 IU has the highest efficacy and lowest side effect profile, although ergometrine, carbetocin and misoprostol are also effective. The appropriate uterotonic in different settings such as home birth by unskilled attendants and at caesarean section is discussed. For the latter, there is less consensus on the optimal dose/route of oxytocin, this topic remaining on the research agenda. Delayed cord clamping enables transfusion of blood to the neonate and is recommended rather than early clamping. Controlled cord traction should only be performed by skilled birth attendants and confers minimal advantage in preventing retained placenta. The importance of early recognition of PPH, and preparedness, is emphasised. An approach to medical and surgical management of PPH is presented.

Antenatal blood transfusion in South Africa: indications and practice in a high-HIV-prevalence setting.

BACKGROUND: Globally, data on antenatal blood transfusion practices are scarce. We sought to characterize the epidemiology of antenatal transfusion in South Africa. STUDY DESIGN AND METHODS: A cross-sectional study was conducted of women who were transfused during pregnancy (>48 hr before anticipated delivery) at two hospitals in Durban and Soweto in 2014 to 2015. Medical record data on demographics, obstetric history, anemia, HIV status, and indications for blood transfusion were abstracted. RESULTS: The records on a total of 560 transfused pregnant women were evaluated; mean age was 28 years, 98% were of black African ethnicity, and 28% were HIV positive. At time of transfusion, one-half were in the first trimester. Hemorrhage was noted in 76% of women, most of which was associated with abortion (67%) or ectopic pregnancy (27%). Most women were transfused with red blood cells (RBCs; median, 2 units); 14% of women were transfused with plasma and 2% with platelets. Median pre- and posttransfusion hemoglobin levels were 6.9 g/dL and 9.2 g/dL, respectively; the latter differed by hospital (8.7 g/dL vs. 9.5 g/dL; p < 0.01). Hemorrhage was associated with missing HIV status, lower gestational age, and transfusion of 3 or more RBC units (all p < 0.01). In contrast, diagnoses of anemia (Soweto only) were associated with HIV infection, later gestational age, and lower (<3 units) RBC dose (all p < 0.01). CONCLUSION: Abortion and ectopic pregnancy with associated hemorrhage were the leading indications for antenatal transfusion and were concentrated in early gestation. By contrast, anemia was associated with HIV infection and transfusion in the third trimester.

A cross sectional analytic study of modes of delivery and caesarean section rates in a private health insured South African population.

BACKGROUND: Monitoring Caesarean Section (CS) rates is essential to ensure optimal use of the procedure. Information on CS rates in the South African private sector is limited and information from this study will assist in planning for the proposed NHI in South Africa. OBJECTIVES: The objectives of this paper are to assess mode of delivery patterns and to determine CS rates amongst South African private health insurance scheme members; and to assess the extent to which CS rates are influenced by age and health status of the mother. METHODS: The 2015 claims for members of 10 health insurance schemes were analysed to assess delivery type patterns. Mode of delivery patterns were assessed by 6 delivery types: emergency, elective and "other" for caesarean deliveries; and non-assisted, assisted and "other" for vaginal deliveries; as well as by age and health condition of the mother. RESULTS: Of a total of 6,542 births analysed, 4,815 were CS giving a CS rate of 73·6% (95% CI 72·5%;74·7%). Emergency CS were the most common mode of delivery (39·7%), followed by elective CS (39·5%). CS rates increased with increasing maternal age and were higher for women with a medical condition. CONCLUSIONS: CS rates for the South African private sector are considerably higher than the safe rates recommended by the WHO. The high CS rates is a cause for concern for the health system under the proposed NHI. To support initiatives encouraging evidence based practice, further research is required to understand the drivers for the high CS rates.

Practical approaches to managing postpartum haemorrhage with limited resources.

Mortality from postpartum haemorrhage (PPH) is higher in low resource settings due to increased incidence, higher case fatality rates and poor general health of the population. The challenges of managing PPH with limited resources are presented. Feasible interventions for preventing and treating PPH for home births are described. Given that maternity care is organised around levels of care in low resource settings, guidance is provided for what measures can be performed to manage PPH at different levels of care (clinic, community health centre, district hospital, regional and central hospital); and by which cadre (midwife, clinical officer, general doctor, specialist). Effective management of PPH requires on-going training and emergency drills. Reducing mortality from PPH is not possible without available urgent transport from home to facility and between levels of care. In addition, the essential building blocks of the health system must be functional to enable effective management of PPH.

Point-of-Care Ultrasound Abnormalities in Late-Onset Severe Preeclampsia: Prevalence and Association With Serum Albumin and Brain Natriuretic Peptide.

BACKGROUND: Pilot studies applying point-of-care ultrasound (POCUS) in preeclampsia indicate the presence of pulmonary interstitial edema, cerebral edema, and cardiac dysfunction. Laboratory markers of oncotic pressure (albumin) and cardiac dysfunction (brain natriuretic peptide [BNP]) may be abnormal, but the clinical application remains unclear. We investigated the prevalence of pulmonary interstitial syndrome (PIS), cardiac dysfunction, and increased optic nerve sheath diameter (ONSD) in late-onset preeclampsia with severe features. The primary aim was to examine the association between PIS or ONSD and maternal serum albumin level. The secondary aims were to explore the association between cardiac dysfunction and PIS, ONSD, BNP, and serum albumin level and between POCUS-derived parameters and a suspicious or pathological cardiotocograph. METHODS: Ninety-five women were enrolled in this prospective observational cohort study. A POCUS examination of lungs, heart, and ONSD was performed. PIS was defined as a bilateral B-line pattern on lung ultrasound and diastolic dysfunction according to an algorithm of the American Society of Echocardiography. ONSD >5.8 mm was interpreted as compatible with raised intracranial pressure (>20 mm Hg). Serum BNP and albumin levels were also measured. RESULTS: PIS, diastolic dysfunction, systolic dysfunction, and raised left ventricular end-diastolic pressure (LVEDP) were present in 23 (24%), 31 (33%), 9 (10%), and 20 (25%) women, respectively. ONSD was increased in 27 (28%) women. Concerning the primary outcome, there was no association between albumin level and PIS (P = .4) or ONSD (P = .63). With respect to secondary outcomes, there was no association between albumin level and systolic dysfunction (P = .21) or raised LVEDP (P = .44). PIS was associated with diastolic dysfunction (P = .02) and raised LVEDP (P = .009; negative predictive value, 85%). BNP level was associated with systolic (P < .001) and diastolic dysfunction (P = .003) and LVEDP (P = .007). No association was found between POCUS abnormalities and a suspicious/pathological cardiotocograph (P = .07). CONCLUSIONS: PIS, diastolic dysfunction, and increased ONSD were common in preeclampsia with severe features. Cardiac ultrasound abnormalities may be more useful than albumin levels in predicting PIS. The absence of PIS may exclude raised LVEDP. The further clinical relevance of PIS and raised ONSD remains to be established. BNP level was associated with cardiac ultrasound abnormalities. Although this study was not designed to directly influence clinical management, the findings suggest that POCUS may serve as a useful adjunct to clinical examination for the obstetric anesthesiologist managing these complex patients.

Prepregnancy and early pregnancy calcium supplementation among women at high risk of pre-eclampsia: a multicentre, double-blind, randomised, placebo-controlled trial.

BACKGROUND: Reducing deaths from hypertensive disorders of pregnancy is a global priority. Low dietary calcium might account for the high prevalence of pre-eclampsia and eclampsia in low-income countries. Calcium supplementation in the second half of pregnancy is known to reduce the serious consequences of pre-eclampsia; however, the effect of calcium supplementation during placentation is not known. We aimed to test the hypothesis that calcium supplementation before and in early pregnancy (up to 20 weeks' gestation) prevents the development of pre-eclampsia METHODS: We did a multicountry, parallel arm, double-blind, randomised, placebo-controlled trial in South Africa, Zimbabwe, and Argentina. Participants with previous pre-eclampsia and eclampsia received 500 mg calcium or placebo daily from enrolment prepregnancy until 20 weeks' gestation. Participants were parous women whose most recent pregnancy had been complicated by pre-eclampsia or eclampsia and who were intending to become pregnant. All participants received unblinded calcium 1·5 g daily after 20 weeks' gestation. The allocation sequence (1:1 ratio) used computer-generated random numbers in balanced blocks of variable size. The primary outcome was pre-eclampsia, defined as gestational hypertension and proteinuria. The trial is registered with the Pan-African Clinical Trials Registry, number PACTR201105000267371. The trial closed on Oct 31, 2017. FINDINGS: Between July 12, 2011, and Sept 8, 2016, we randomly allocated 1355 women to receive calcium or placebo; 331 of 678 participants in the calcium group versus 320 of 677 in the placebo group became pregnant, and 298 of 678 versus 283 of 677 had pregnancies beyond 20 weeks' gestation. Pre-eclampsia occurred in 69 (23%) of 296 participants in the calcium group versus 82 (29%) of 283 participants in the placebo group with pregnancies beyond 20 weeks' gestation (risk ratio [RR] 0·80, 95% CI 0·61-1·06; p=0·121). For participants with compliance of more than 80% from the last visit before pregnancy to 20 weeks' gestation, the pre-eclampsia risk was 30 (21%) of 144 versus 47 (32%) of 149 (RR 0·66, CI 0·44-0·98; p=0·037). There were no serious adverse effects of calcium reported. INTERPRETATION: Calcium supplementation that commenced before pregnancy until 20 weeks' gestation, compared with placebo, did not show a significant reduction in recurrent pre-eclampsia. As the trial was powered to detect a large effect size, we cannot rule out a small to moderate effect of this intervention. FUNDING: The University of British Columbia, a grantee of the Bill & Melinda Gates Foundation; UNDP-UNFPA-UNICEF-WHO-World Bank Special Programme of Research, Development and Research Training in Human Reproduction, WHO; the Argentina Fund for Horizontal Cooperation of the Argentinean Ministry of Foreign Affairs; and the Centre for Intervention Science in Maternal and Child Health.

Risk factors for peripartum blood transfusion in South Africa: a case-control study.

BACKGROUND: Obstetric hemorrhage (OH) and access to peripartum blood transfusion remains a global health challenge. The rates of peripartum transfusion in South Africa exceed those in high-income countries despite comparable rates of OH. We sought to evaluate factors associated with peripartum transfusion. STUDY DESIGN AND METHODS: A case-control study was conducted at four large South African hospitals. Transfused peripartum women (cases) and nontransfused controls were stratum matched 1:2 by hospital and delivery date. Data on obstetric, transfusion, and human immunodeficiency virus (HIV) history were abstracted from medical records. Blood was obtained for laboratory evaluation. We calculated unadjusted and adjusted odds ratios (ORs) for transfusion using logistic regression. RESULTS: A total of 1200 transfused cases and 2434 controls were evaluated. Antepartum hemorrhage (OR, 197.95; 95% confidence interval [CI], 104.27-375.78), hemorrhage with vaginal delivery (OR, 136.46; 95% CI, 75.87-245.18), prenatal anemia (OR, 22.76; 95% CI, 12.34-41.93 for prenatal hemoglobin level < 7 g/dL), and failed access to prenatal care (OR, 6.71; 95% CI, 4.32-10.42) were the major risk factors for transfusion. Platelet (PLT) count (ORs, 4.10, 2.66, and 1.77 for ≤50 × 109 , 51 × 109 -100 × 109 , and 101 × 109 -150 × 109 cells/L, respectively), HIV infection (OR, 1.29; 95% CI, 1.02-1.62), and admitting hospital (twofold variation) were also associated with transfusion. Mode of delivery, race, age category, gravidity, parity, gestational age, and birthweight were not independently associated with transfusion. CONCLUSION: Major risk factors of peripartum transfusion in South Africa, namely, prenatal anemia and access to prenatal care, may be amenable to intervention. HIV infection and moderately low PLT count are novel risk factors that merit further investigation.

Development spots in communication during the management of the intrapartum period: An interpretive multiple case study in a developing context.

BACKGROUND: Health care activities are influenced by information communication between women during pregnancy, birth and motherhood and skilled birth attendants (SBAs) and further, between the health care workers during the continuum of care. Therefore, effective information communication processes (ICP) within and between health care facilities are a requirement for appropriate management of patients or clients. The management of the intrapartum period requires swift responses while managing critical information required for further referral and management processes. The involvement of multiple actors at different times with the same client carries the risk of communication breakdown at different points and at different levels of care. The information communicated during the intrapartum period is critical and should be accurate, timely and more importantly appropriate to enable better maternal and neonatal outcomes. PURPOSE: The purpose of this article is to discuss the complexities around ICP identified within a developing context that influence the management of the intrapartum period. METHODS: Multi-method, multiple case study approach was used to analyse two case studies. Only the challenges from one case study (A) are discussed in this article. In-depth interviews were conducted with the SBAs. The role of observer-as-participant was utilised during the observation; field notes and document review methods were used to gather the data. Thematic analysis and activity analysis were applied to analyse the data. RESULTS: The findings identified challenges with information and communication that influenced the management of the intrapartum period. CONCLUSION: This study exhibited the challenges identified as development points that can influence the management of the intrapartum period. These challenges were also identified as desirable changes from the present state depending on the perspective of the actor.

Maternal mortality and unsafe abortion.

Unsafe abortions refer to terminations of unintended pregnancies by persons lacking the necessary skills, or in an environment lacking the minimum medical standards, or both. Globally, unsafe abortions account for 67,900 maternal deaths annually (13% of total maternal mortality) and contribute to significant morbidity among women, especially in under-resourced settings. The determinants of unsafe abortion include restrictive abortion legislation, lack of female empowerment, poor social support, inadequate contraceptive services and poor health-service infrastructure. Deaths from unsafe abortion are preventable by addressing the above determinants and by the provision of safe, accessible abortion care. This includes safe medical or surgical methods for termination of pregnancy and management of incomplete abortion by skilled personnel. The service must also include provision of emergency medical or surgical care in women with severe abortion complications. Developing appropriate services at the primary level of care with a functioning referral system and the inclusion of post abortion contraceptive care with counseling are essential facets of abortion care.