Cohort profile: the Western Cape Pregnancy Exposure Registry (WCPER).

PURPOSE: The Western Cape Pregnancy Exposure Registry (PER) was established at two public sector healthcare sentinel sites in the Western Cape province, South Africa, to provide ongoing surveillance of drug exposures in pregnancy and associations with pregnancy outcomes. PARTICIPANTS: Established in 2016, all women attending their first antenatal visit at primary care obstetric facilities were enrolled and followed to pregnancy outcome regardless of the site (ie, primary, secondary, tertiary facility). Routine operational obstetric and medical data are digitised from the clinical stationery at the healthcare facilities. Data collection has been integrated into existing services and information platforms and supports routine operations. The PER is situated within the Provincial Health Data Centre, an information exchange that harmonises and consolidates all health-related electronic data in the province. Data are contributed via linkage across a unique identifier. This relationship limits the missing data in the PER, allows validation and avoids misclassification in the population-level data set. FINDINGS TO DATE: Approximately 5000 and 3500 pregnant women enter the data set annually at the urban and rural sites, respectively. As of August 2021, >30 000 pregnancies have been recorded and outcomes have been determined for 93%. Analysis of key obstetric and neonatal health indicators derived from the PER are consistent with the aggregate data in the District Health Information System. FUTURE PLANS: This represents significant infrastructure, able to address clinical and epidemiological concerns in a low/middle-income setting.

PROTEA, A Southern African Multicenter Congenital Heart Disease Registry and Biorepository: Rationale, Design, and Initial Results.

Objectives: The PartneRships in cOngeniTal hEart disease (PROTEA) project aims to establish a densely phenotyped and genotyped Congenital Heart Disease (CHD) cohort for southern Africa. This will facilitate research into the epidemiology and genetic determinants of CHD in the region. This paper introduces the PROTEA project, characterizes its initial cohort, from the Western Cape Province of South Africa, and compares the proportion or "cohort-prevalences" of CHD-subtypes with international findings. Methods: PROTEA is a prospective multicenter CHD registry and biorepository. The initial cohort was recruited from seven hospitals in the Western Cape Province of South Africa from 1 April 2017 to 31 March 2019. All patients with structural CHD were eligible for inclusion. Descriptive data for the preliminary cohort are presented. In addition, cohort-prevalences (i.e., the proportion of patients within the cohort with a specific CHD-subtype) of 26 CHD-subtypes in PROTEA's pediatric cohort were compared with the cohort-prevalences of CHD-subtypes in two global birth-prevalence studies. Results: The study enrolled 1,473 participants over 2 years, median age was 1.9 (IQR 0.4-7.1) years. Predominant subtypes included ventricular septal defect (VSD) (339, 20%), atrial septal defect (ASD) (174, 11%), patent ductus arteriosus (185, 11%), atrioventricular septal defect (AVSD) (124, 7%), and tetralogy of Fallot (121, 7%). VSDs were 1.8 (95% CI, 1.6-2.0) times and ASDs 1.4 (95% CI, 1.2-1.6) times more common in global prevalence estimates than in PROTEA's pediatric cohort. AVSDs were 2.1 (95% CI, 1.7-2.5) times more common in PROTEA and pulmonary stenosis and double outlet right ventricle were also significantly more common compared to global estimates. Median maternal age at delivery was 28 (IQR 23-34) years. Eighty-two percent (347/425) of mothers used no pre-conception supplementation and 42% (105/250) used no first trimester supplements. Conclusions: The cohort-prevalence of certain mild CHD subtypes is lower than for international estimates and the cohort-prevalence of certain severe subtypes is higher. PROTEA is not a prevalence study, and these inconsistencies are unlikely the result of true differences in prevalence. However, these findings may indicate under-diagnosis of mild to moderate CHD and differences in CHD management and outcomes. This reemphasizes the need for robust CHD epidemiological research in the region.

Maternal characteristics and pregnancy outcomes of hospitalized pregnant women with SARS-CoV-2 infection in South Africa: An International Network of Obstetric Survey Systems-based cohort study.

OBJECTIVE: To describe risk factors and outcomes of pregnant women infected with SARS-CoV-2 admitted to South African healthcare facilities. METHODS: A population-based cohort study was conducted utilizing an amended International Obstetric Surveillance System protocol. Data on pregnant women with SARS-CoV-2 infection, hospitalized between April 14, 2020, and November 24, 2020, were analyzed. RESULTS: A total of 36 hospitals submitted data on 673 infected hospitalized pregnant women; 217 (32.2%) were admitted for COVID-19 illness and 456 for other indications. There were 39 deaths with a case fatality rate of 6.3%: 32 (14.7%) deaths occurred in women admitted for COVID-19 illness compared to 7 (1.8%) in women admitted for other indications. Of the women, 106 (15.9%) required critical care. Maternal tuberculosis, but not HIV co-infection or other co-morbidities, was associated with admission for COVID-19 illness. Rates of cesarean delivery did not differ significantly between women admitted for COVID-19 and those admitted for other indications. There were 179 (35.4%) preterm births, 25 (4.7%) stillbirths, 12 (2.3%) neonatal deaths, and 162 (30.8%) neonatal admissions. Neonatal outcomes did not differ significantly from those of infected women admitted for other indications. CONCLUSION: The maternal mortality rate was high among women admitted with SARS-CoV-2 infection and higher in women admitted primarily for COVID-19 illness with tuberculosis being the only co-morbidity associated with admission.

Managing Rheumatic Heart Disease in Pregnancy: A Practical Evidence-Based Multidisciplinary Approach.

Rheumatic heart disease (RHD) remains a leading cause of mortality and morbidity in pregnant patients in low- to middle-income countries. Apart from the clinical challenges, these areas face poor infrastructure and resources to allow for early detection, with many women presenting to medical services for the first time when they deteriorate clinically during the pregnancy. The opportunity for preconception counselling and planning may thus be lost. It is ideal for all women to be seen before conception and risk-stratified according to their clinical state and pathology. The role of the cardio-obstetrics team has emerged over the past decade with the aim of a seamless transition to and from the appropriate levels of care during pregnancy. Severe symptomatic mitral and aortic valve stenoses portend the greatest risk to both mother and fetus. In mitral stenosis, beta-blockers are the cornerstone of therapy and only a small number of patients require balloon valvuloplasty. Regurgitant lesions mostly require diuretics alone for the treatment of heart failure. The mode of delivery is usually vaginal; caesarean section is performed in those with obstetrical indications or in cases with severe stenosis and a poor clinical state. The postpartum period presents a second high-risk period for maternal adverse events, with heart failure and arrhythmias being the most frequent. This review aims to provide a practical evidence-based multi-disciplinary approach to the management of women with RHD in pregnancy.

Effectiveness of Implanted Cardiac Rhythm Recorders With Electrocardiographic Monitoring for Detecting Arrhythmias in Pregnant Women With Symptomatic Arrhythmia and/or Structural Heart Disease: A Randomized Clinical Trial.

Importance: Arrhythmias are an important cause of maternal morbidity and mortality but remain difficult to diagnose. Objective: To compare implantable loop recorder (ILR) plus 24-hour Holter electrocardiographic (ECG) monitoring with standard 24-hour Holter ECG monitoring alone in terms of acceptability, ability to identify significant arrythmias, and effect on management and pregnancy outcome in women who were symptomatic or at high risk of arrythmia because of underlying structural heart disease. Design, Setting, and Participants: This single-center, prospective randomized clinical trial recruited 40 consecutive patients from the Cardiac Disease and Maternity Clinic at Groote Schuur Hospital in Cape Town, South Africa. Pregnant patients with symptoms of arrhythmia and/or structural heart disease at risk of arrhythmia were included. Intervention: Patients were randomized to standard care (SC; 24-hour Holter ECG monitoring [n = 20]) or standard care plus ILR (SC-ILR; 24-hour Holter ECG monitoring plus ILR [n = 20]). Only 17 consented to ILR insertion, and the 3 who declined ILR were allocated to the SC group. Main Outcomes and Measures: Arrhythmias considered included atrial fibrillation, atrial flutter, premature ventricular complexes, supraventricular tachycardia, ventricular tachycardia, or ventricular fibrillation. Results: Among the 40 women in this trial, the mean (SD) age was 28.4 (5.5) years. Holter monitoring detected arrhythmias in 3 of 23 patients (13%) in the SC group and 4 of 17 patients (24%) in the SC-ILR group compared with 9 of 17 patients (53%) patients who had arrhythmias detected by ILR. Seven patients (4 with supraventricular tachycardia, 1 with premature ventricular complexes, and 2 with paroxysmal atrial fibrillation recorded by ILR) did not have arrhythmias detected by 24-hour Holter monitoring. Three of these 7 patients (43%) had a change in management as a result of their ILR recordings. There were no maternal deaths. However, the SC group had a significantly lower mean (SD) gestational stage at delivery (35 [5] weeks vs 38 [2], P = .04). Conclusions and Relevance: The ILR was better than 24-hour Holter monitoring in detecting arrhythmias, which led to a change in management for a significant proportion of patients. Our findings suggest that ILR may be beneficial for pregnant women at risk of arrhythmia. Trial Registration: ClinicalTrials.gov Identifier: NCT02249195.

The effect of beta-blockers on foetal birth weight in pregnancies in women with structural heart disease: a prospective cohort study.

OBJECTIVE: To examine whether treatment with beta-blockers (BBs) in pregnant women with structural heart disease (SHD) resulted in a decrease in foetal birth weight (FBW) in a South African cohort. METHODS: This was a prospective cohort study conducted in a tertiary-level hospital in Cape Town from 2010 to 2016. Of the 178 pregnant women with SHD, 24.2% received BBs for a minimum of two weeks. Adverse foetal outcomes and mean FBW were compared between the BB groups and subgroups (congenital, valvular, cardiomyopathy and other). Adverse foetal outcome was defined as: low birth weight (LBW) < 2 500 g, Apgar score < 7, premature birth (< 37 weeks) and small for gestational age (SGA). RESULTS: BB exposure during pregnancy was found to be associated with a non-significant increased FBW (2 912 vs 2 807 g, p = 0.347). A significant decrease (p = 0.009) was noted in FBW for valvular SHD pregnancies using BBs, while a significant increase (p = 0.049) was observed for the same outcome in the cardiomyopathy subgroup using BBs. A significant increase was observed for SGA (p = 0.010) and LBW (p = 0.003) pregnancies within the valvular subgroup when exposed to BBs. CONCLUSIONS: BB use in pregnant women with SHD in a South African cohort showed no association with a decrease in FBW or an increase in adverse foetal outcomes when compared to non-BB usage.

Bilateral endophthalmitis and symmetrical peripheral gangrene in a patient with chronic kidney disease on maintenance hemodialysis.

Dialysis patients have greater number of complications due to multiple comor-bidity and access-related infections as well as nosocomial infections due to reduced immunity and more frequent hospitalizations. Endogenous endophthalmitis is a potentially blinding ocular infection occurring in chronically debilitated patients and the use of invasive procedures. Symmetric peripheral gangrene (SPG) is defined as symmetrical distal ischemic damage in two or more sites in the absence of a major vascular occlusive disease. It carries a high mortality rate with a very high frequency of multiple limb amputations in the survivors. However, only a few case reports have described endogenous endophthalmitis in dialysis patients. Concomitant endophthalmitis and disseminated intravascular coagulation (DIC), presenting as SPG, is extremely rare and no such case was found in the literature survey. Herein, we report a very rare association of bilateral endophthalmitis with DIC and SPG in a patient with chronic kidney disease on maintenance hemodialysis.

Reducing late maternal death due to cardiovascular disease - A pragmatic pilot study.

BACKGROUND: Late maternal mortality (up-to 1-year postpartum) is poorly reported globally and is commonly due to cardiovascular disease (CVD). We investigated targeted interventions aiming at reducing peripartum heart failure admission and late maternal death. METHODS AND RESULTS: Prospective single-centre study of 269 peripartum women presenting with CVD in pregnancy, or within 6-months postpartum. Both cardiac disease maternity (CDM) Group-I and Group-II were treated by a dedicated cardiac-obstetric team. CDM Group-II received additional interventions: 1. Early (2-6 weeks) postpartum follow-up at the CDM clinic and immediate referral to dedicated CVD specialist clinics. 2. Beta-blocker therapy was continued in women with LVEF<45% while pregnant, or immediately started postpartum. Of 269 consecutive women (mean age 28.6 ±â€¯5.9), 213 presented prepartum, 22% in NYHA groups III-IV and 79% in modified WHO groups III-IV. Patients were diagnosed with congenital heart disease (30%), valvular heart disease (25%) and cardiomyopathy (31%). The groups were similar in age, diagnosis, NYHA, modified WHO, BP and HIV, but Group-II had a higher rate of previously known CVD (p < 0.001) and a lower rate of being nulliparous (p < 0.0005). Of Group-I patients 9 died within the 12-month follow-up period versus one death in Group-II (p = 0.047). Heart failure leading to admission was 32% in Group-I versus 14% in Group-II (p = 0.0008), with Group-II having a higher beta-blocker use peripartum (p = 0.009). Perinatal mortality rate was 22/1000 live births with no differences between groups. CONCLUSION: Early follow-up in a dedicated CDM clinic with targeted pharmacological interventions led to a significant reduction in peripartum heart failure admission and mortality.

Valvular heart disease in pregnancy.

Valvular heart disease may be a pre-existing complication of pregnancy or it may be diagnosed for the first time during pregnancy. Accurate diagnosis, tailored therapy and an understanding of the physiology and pathophysiology of pregnancy are necessary components of management, best achieved through the use of multidisciplinary clinics. This review outlines the management of specific lesions, with particular reference to post-rheumatic valvular heart disease.

Reproductive knowledge and use of contraception among women with diabetes.

BACKGROUND: Poorly controlled diabetes is associated with poor maternal and fetal outcomes, yet many women become pregnant before establishing control. Reducing unintended pregnancies is a vital step towards improving perinatal and maternal morbidity and mortality. OBJECTIVES: To assess the reproductive knowledge and use of contraception in women of reproductive age attending diabetes outpatient clinics. METHODS: A prospective descriptive study was conducted of women known to have diabetes, aged 18 - 45 years, attending the diabetic clinics at Groote Schuur Hospital or the local community health centres in Cape Town, South Africa. A questionnaire consisting of social, demographic and family details as well as contraceptive use and knowledge was administered. RESULTS: Some common themes emerged, namely that 44.2% of the women with previous pregnancies had had unintended pregnancies, and that this was more common among single (58.8%) and younger women. Women with type 1 diabetes had better knowledge than those with type 2 diabetes of how pregnancy affects diabetes, but better knowledge did not translate to better contraception use. Despite the fact that 102 participants (88.7%) attended diabetes clinics two or more times a year, knowledge of pregnancy- and reproductive health-related complications was limited, and only 30 participants (26.1%) had received advice on contraception at these clinics. CONCLUSION: Knowledge about the impact of diabetes on pregnancy and that of pregnancy on diabetes was suboptimal. We recommend that reproductive health services be included at the routine diabetes clinic visit.

Spectrum of cardiac disease in maternity in a low-resource cohort in South Africa.

BACKGROUND: Lack of evidence-based data on the spectrum of cardiovascular disease (CVD) in pregnancy or in the postpartum period, as well as on maternal and fetal outcome, provides challenges for treating physicians, particularly in areas of low resources. The objectives of this study were to investigate the spectrum of disease, mode of presentation and maternal and fetal outcome of patients referred to a dedicated Cardiac Disease and Maternity Clinic (CDM). METHODS: The prospective cohort study was conducted at a single tertiary care centre in South Africa. Two hundred and twenty-five women presenting with CVD in pregnancy, or within 6 months postpartum, were studied over a period of 2 years. Clinical assessment, echocardiography and laboratory tests were performed at baseline and follow-up visits. Prepartum, peripartum and postpartum complications were grouped into cardiac, neonatal and obstetric events. RESULTS: Ethnicity was black African (45%), mixed ethnicity (32%), white (15%), Indian/others (8%) and 12% were HIV positive. Of the 225 consecutive women (mean age 28.8±6.4), 196 (86.7%) presented prepartum and 73 in modified WHO class I. The 152 women presenting in a higher risk group (modified WHO class II-IV) were offered close follow-up at the CDM clinic and were diagnosed with congenital heart disease (32%, 15 operated previously), valvular heart disease (26%, 15 operated previously), cardiomyopathy (27%) and other (15%). Women presenting with symptoms of CVD or heart failure postpartum (n=30) presented in a higher New York Heart Association, had higher heart rates (p<0.001) and NTproBNP levels (p<0.0005). Of the 152 patients, 9 (6%) died within the 6-month follow-up period. Eight of the nine patients died >42 days postpartum. Perinatal death occurred in 1/152 (0.7%)-translating to a perinatal mortality rate of 7/1000 live births. CONCLUSIONS: Disease patterns were markedly different to that seen in the developed world. However, joint obstetric-cardiac care in the low-resource cohort was associated with excellent survival outcome rates of pregnant mothers (even with complex diseases) and their offspring and was similar to that seen in the western world. Mortality typically occurred in the postpartum period, beyond the standard date of recording maternal death.