Reliability and validity of last menstrual period for gestational age estimation in a low-to-middle-income setting.

AIM: Gestational age estimation by ultrasonography is the gold standard for dating pregnancies. However, the availability of prenatal ultrasonography in low-to-middle-income countries is limited. This study aimed to assess the reliability and validity of last menstrual period (LMP) as a gestational age dating method among women in Johannesburg, South Africa. METHODS: A total of 741 pregnant women were enrolled into a longitudinal study (June 2013 to July 2016). Gestational age was determined by LMP and ultrasonography. Differences in ultrasound-based and LMP-based gestational age estimates were assessed according to the American College of Obstetrics and Gynecologists' guidelines and women were classified as having discrepant results or not. Multiple statistical analyses determined the level of agreement between the two methods and validity of LMP estimates. RESULTS: Compared to ultrasound, dating by LMP assessed gestational age as 0.2 days longer. Women with discrepant results were of significantly lower weight and household socioeconomic status than those without discrepancies. While there was a substantial agreement (k = 0.64; 95% confidence interval, CI: 0.54, 0.71, P < 0.001) between the two methods, LMP only had a 29.0% (95% CI: 14.2, 48.0) sensitivity in identifying late-term neonates and a 33.3% (95% CI: 4.33, 77.7) sensitivity in identifying post-term neonates. CONCLUSION: In the absence of ultrasound, LMP is a reliable alternative for gestational age dating during early pregnancy. However, it is not sensitive in identifying late- and post-term pregnancies and should not be relied upon to make clinical decisions regarding elective cesarean section or induction of labor for supposed prolonged pregnancies.

Serotype-Specific Cell-Mediated Immunity Associated With Clearance of Homotypic Group B Streptococcus Rectovaginal Colonization in Pregnant Women.

We investigated the association between group B Streptococcus (GBS) serotype-specific capsular polysaccharide cellular immunity, measured with enzyme-linked immunospot (ELISPOT) interferon γ release assay at 20 weeks gestation in pregnant women, and its effect on rectovaginal serotype-specific GBS colonization up to 37 weeks gestation. Among women colonized by serotype III at enrollment, interferon γ ELISPOT positivity was more common in those in whom colonization was cleared (44.4%) than in those in whom colonization persisted (7.4%; P = .008), with a similar trend observed for serotype Ia. Presence of serotype-specific capsular polysaccharide cell-mediated immunity contributes to the clearance of GBS rectovaginal colonization.

Evaluation of Trans-Vag broth, colistin-nalidixic agar, and CHROMagar StrepB for detection of group B Streptococcus in vaginal and rectal swabs from pregnant women in South Africa.

Maternal vaginal colonization with group B streptococcus (GBS) is a major risk factor for invasive GBS infection in newborns. The CDC-recommended method for detecting GBS colonization is to culture vaginal and rectal swabs in a selective broth followed by subculture on blood agar or a selective medium. A high incidence of antimicrobial resistance in the fecal microflora can compromise the recovery of GBS from the selective broth. Here, we compared CHROMagar StrepB (CA), Columbia colistin-nalidixic agar (CNA), and Trans-Vag selective broth enrichment for the isolation of GBS from 130 vaginal and 130 rectal swabs from pregnant women. The swabs were randomized for plating first on either CA or CNA, and they then were inoculated in Trans-Vag broth. GBS was cultured from 37.7% of the vaginal swabs and 33.1% of the rectal swabs. There were no differences in the detection rates for the vaginal swabs between CA (31.5%), CNA (26.2%), and the selective broth (30.0%). The sensitivities in relation to a composite score were 83.7%, 69.4%, and 79.6%, respectively. However, recovery of GBS from the rectal swabs was significantly higher from CA (29.2%; P<0.0001) and CNA (23.8%; P=0.002) than from the selective broth (9.2%). The sensitivities were 88.4%, 72.1%, and 27.9%, respectively. The order of plating on the solid medium was significant (P=0.003), with GBS detection rates of 30.8% and 24.6% when swabs were plated first and second, respectively. These findings show that a selective broth is not suitable for the recovery of GBS from rectal swabs in settings such as ours, due to masking of the GBS colonies by persistent microflora.

Implementation of a PMTCT programme in a high HIV prevalence setting in Johannesburg, South Africa: 2002-2015.

BACKGROUND: Great strides have been made in decreasing paediatric human immunodeficiency virus (HIV) infections, especially in sub-Saharan Africa. In South Africa, new paediatric HIV infections decreased by 84% between 2009 and 2015. This achievement is a result of a strong political will and the rapid evolution of the country's prevention of mother-to-child transmission (PMTCT) guidelines. OBJECTIVES: In this paper we report on the implementation of a large PMTCT programme in Soweto, South Africa. METHODS: We reviewed routinely collected PMTCT data from 13 healthcare facilities, for the period 2002-2015. Antiretroviral therapy (ART) coverage among pregnant women living with HIV (PWLHIV) and the mother-to-child transmission (MTCT) rate at early infant diagnosis were evaluated. RESULTS: In total, 360 751 pregnant women attended the facilities during the review period, and the HIV prevalence remained high throughout at around 30%. The proportion of PWLHIV presenting with a known HIV status increased from 14.3% in 2009 when the indicator was first collected to 45% in 2015, p < 0.001. In 2006, less than 10% of the PWLHIV were initiated on ART, increasing to 88% by 2011. The MTCT rate decreased from 6.9% in 2007 to under 1% from 2013 to 2015, p < 0.001. CONCLUSION: The achievements in decreasing paediatric HIV infections have been hailed as one of the greatest public health achievements of our times. While there are inherent limitations with using routinely collected aggregate data, the Soweto data reflect progress made in the implementation of PMTCT programmes in South Africa. Progress with PMTCT has, however, not been accompanied by a decline in HIV prevalence among pregnant women.

Role of a second stage partogram in predicting the outcome of normal labour.

BACKGROUND: Management of the second stage of labour is dictated by arbitrary time limits rather than true measures of progress. No partogram is available for second stage of labour. OBJECTIVES: To evaluate a partogram designed for use for the second stage of labour. METHODS: This prospective cross-sectional analytical study included low-risk pregnant women with singleton fetuses with vertex presentations at term. From onset of the second stage, vaginal examinations were performed every 30 min until delivery. A scoring system developed by Sizer et al. was used based on station and position of fetal head. Scores were plotted on a second stage partogram and used to predict labour outcomes, such as duration of second stage and mode of delivery. RESULTS: Of 79 women examined, 73 had spontaneous vaginal delivery. Of the remaining six, four required oxytocin infusion and other two required vacuum extraction. The median durations of the second stage of labour for primigravidas (n = 34) and multigravidas (n = 45) were 35 and 25 min, respectively. The median Sizer's partogram score at the onset of second stage was 4. Multiple regression analysis showed that the partogram score (r2 = 0.27) and gravidity (r2 = 0.10) were independent predictors of duration of the second stage. There was a significant association between second stage progress plotted to the right of the partogram line and non-spontaneous delivery (P = 0.01). CONCLUSION: The second stage partogram score at onset can predict the duration of second stage. Poor progress plotted on the partogram is associated with non-spontaneous delivery.

Accuracy of five plasma calibrated glucometers to screen for and diagnose gestational diabetes mellitus in a low resource clinic setting.

AIMS: We investigated the clinical and analytic accuracy of five plasma calibrated glucometers, the use of which is advocated by the World Health Organisation and the International Federation of Gynaecology and Obstetrics, to screen for and diagnose gestational diabetes mellitus (GDM) in low resource settings. METHODS: 592 consecutive black African women underwent a 75 g oral glucose tolerance test (OGTT) at 24-28 weeks gestation at an urban South African community health clinic. Capillary glucose was measured by one of five glucometer brands, each paired with a routine laboratory hexokinase method of plasma glucose measurement. The laboratory results served as the gold standard reference test for GDM diagnosis. World Health Organisation GDM diagnostic thresholds were applied to glucometer and laboratory results. RESULTS: Glucometer and laboratory determined GDM prevalence was 75/592 (12.7%) and 30/592 (5.1%) with an elevated fasting glucose diagnostic in 64/75 (85%) and 24/30 (80%) of cases respectively. The proportion of glucometer results fulfilling ISO 15197:2013 recommended analytic accuracy at fasting, 60, and 120 min of the OGTT was 92.4%, 49.8% and 61.5%, with Bland Altman method revealing a positive glucometer bias of 0.22 mmol/l (-0.69-1.12 mmol/l), 0.96 mmol/l (-0.65-2.56 mmol/l) and 0.73 mmol/l (-0.73-2.19 mmol/l) respectively. Only three of the glucometer brands evaluated fulfilled ISO 15197:2013 analytic accuracy requirements and this was only achieved at fasting. All glucometers tested were inaccurate at one and two hours of the OGTT. CONCLUSIONS: Not all glucometers may be suitable for GDM screening as only three were accurate compared to the reference test and then only at fasting of the OGTT. Importantly, laboratory fasting glucose was diagnostic of GDM in 80% of cases in this study population.

The impact of differences in plasma glucose between glucose oxidase and hexokinase methods on estimated gestational diabetes mellitus prevalence.

We evaluated the extent of measurement discordance between glucose oxidase and hexokinase laboratory methods and the effect of this on estimated gestational diabetes mellitus (GDM) prevalence in a routine clinical setting. 592 consecutive urban African women were screened for GDM. Paired venous specimens were submitted to two independent calibrated laboratories that used either method to measure plasma glucose concentrations. World Health Organisation diagnostic criteria were applied. GDM prevalence determined by the glucose oxidase and hexokinase methods was 6.9% and 5.1% respectively. The overall GDM prevalence was 9%. Only 34% of GDM positive diagnoses were common to both laboratory methods. Bland Altman plots identified a bias of 0.2 mmol/l between laboratory methods. Plasma glucose concentrations measured by the glucose oxidase method were more platykurtic in distribution. Low diagnostic agreement between laboratory methods was further indicated by a Cohen's kappa of 0.48 (p < 0.001). Reports of GDM prevalence using either the glucose oxidase or hexokinase laboratory methods may not be truly interchangeable or directly comparable.

Sagittal suture overlap in cephalopelvic disproportion: blinded and non-participant assessment.

OBJECTIVE: To determine the role of assessment of overlap of fetal skull bones (molding) in intrapartum prediction of cephalopelvic disproportion (CPD). DESIGN: Prospective cross-sectional study. SETTING: South African high-risk obstetric unit that receives referrals from other facilities. POPULATION: Women of at least 37 weeks' gestation in the active phase of labor, with singleton vertex presentations and live fetuses, and without previous cesarean sections. METHOD: The researcher was blinded to parity and previous clinical information on the women, and not involved in their obstetric care. The researcher performed clinical assessments, including estimation of level of head, cervical dilatation, head flexion, position, overlap of fetal skull bones, caput succedaneum and asynclitism. A single assessment was done on each woman. MAIN OUTCOME MEASURE: CPD, defined as cesarean section for poor progress in labor. RESULTS: The author examined 504 women, and CPD occurred in 113 (22.4%). In multivariate logistic regression analysis, sagittal suture overlap was independently associated with CPD. Other factors associated were maternal height, duration of labor, birth weight, and the interaction between caput succedaneum and cervical dilatation at the time of examination. Lambdoid suture overlap was not significantly associated with CPD, and could be determined in only 66.5% of examinations because of frequent head deflexion. CONCLUSION: Assessment of sagittal suture overlap, but not lambdoid suture overlap, is useful for prediction of CPD. Knowledge of sagittal suture overlap may assist in decisions on clinical management where there is poor progress in a trial of labor.

Trends in maternal deaths in HIV-infected women, on a background of changing HIV management guidelines in South Africa: 1997 to 2015.

INTRODUCTION: As work begins towards the Sustainable Development Goal target of reducing the global maternal mortality ratio (MMR) to less than 70 deaths per 100,000 live births by 2030, much needs to be done in ending preventable maternal deaths. After 1990, South Africa experienced a reversal of gains in decreasing maternal mortality, with an increase in HIV-related maternal deaths. In this study, we assessed trends in maternal mortality in HIV-infected women, on a background of an evolving HIV care programme. METHODS: This was a cross-sectional, retrospective record review of maternal deaths in the obstetrics unit at Chris Hani Baragwanath Academic Hospital, in Johannesburg, South Africa, a referral hospital in a high HIV prevalence setting where the prevalence among pregnant women has plateaued around 29.0% for the past decade. Trends in HIV diagnosis and management in pregnancy, and causes of maternal deaths in HIV-infected women were analysed over different time periods (1997 to 2003, 2004 to 2009, 2010 to 2012, and 2013 to 2015) reflecting major guideline changes. RESULTS: From January 1997 to December 2015, there were 692 maternal deaths in the obstetrics unit. Of the 490 (70.8%) maternal deaths with a documented HIV status, 335 (68.4%) were HIV-infected. A Chi-squared test for trends showed that the institutional MMR (iMMR) in women known to be HIV-infected peaked in the period 2004 to 2009 at 380 (95% CI 319 to 446) per 100,000 live births, with a decline to 267 (95% CI 198 to 353) in 2013 to 2015, p = 0.049. This decrease coincided with changes in the South African HIV management guidelines, mainly increased availability of antiretroviral therapy (ART). Non-pregnancy related infections were the leading cause of death throughout the review period, accounting for 61.5% (206/335) of deaths. Only 23.3% (78/335) of the women who died were on ART at the time of death, this in the context of advanced immune suppression and an overall median CD4 count of 136 cells/µl (interquartile ranges (IQR) 45 to 301). CONCLUSION: In this 19-year review of maternal deaths in Johannesburg, South Africa, there was evidence of a decrease in the iMMR among HIV-infected women, but it remains unacceptably high. Efforts to address drivers of mortality and barriers to accessing ART need to be accelerated if we are to see substantial decreases in maternal mortality.

A study of fresh stillbirths weighing 2500g or more at three academic hospitals in South Africa.

OBJECTIVE: To determine the frequency of fresh stillbirths weighing 2500g or more, to assess the risk factors and direct obstetric causes, and to describe avoidable factors in terms of substandard intrapartum management. METHODS: A prospective, cross-sectional, descriptive study was conducted at three obstetric teaching units in Johannesburg, South Africa. Data were consecutively collected for 6months at each of the hospitals, leading to an 18-month data collection period from May 1, 2011, to October 31, 2012. The study population was hospital-born, singleton fresh stillbirths weighing 2500g or more. RESULTS: Overall, 52 fresh stillbirths were eligible. Intrapartum catastrophic events were recorded in 30 (58%) cases (16 placental abruption, 7 cord prolapse, 4 ruptured uterus, and 3 entrapment of aftercoming head during breech delivery). Intrauterine fetal death was recorded on arrival at hospital in 15 (29%) cases. Twenty-two (42%) women underwent cardiotocography monitoring; 15 (29%) had no fetal monitoring. Among 25 cases in which the emergency was recognized, the median time from recognition of emergency to delivery was 182minutes (range 13-360). CONCLUSION: There appears to be a failure to detect or respond to evidence of fetal distress even in facilities with skilled staff and available resources.

Preventing deaths from complications of labour and delivery.

The process of labour and delivery remains an unnecessary and preventable cause of death of women and babies around the world. Although the rates of maternal and perinatal death are declining, there are large disparities between rich and poor countries, and sub-Saharan Africa has not seen the scale of decline as seen elsewhere. In many areas, maternity services remain sparse and under-equipped, with insufficient and poorly trained staff. Priorities for reducing the mortality burden are provision of safe caesarean section, prevention of sepsis and appropriate care of women in labour in line with the current best practices, appropriately and affordably delivered. A concern is that large-scale recourse to caesarean delivery has its own dangers and may present new dominant causes for maternal mortality. An area of current neglect is newborn care. However, innovative training methods and appropriate technologies offer opportunities for affordable and effective newborn resuscitation and follow-up management in low-income settings.

Infant feeding knowledge, perceptions and practices among women with and without HIV in Johannesburg, South Africa: a survey in healthcare facilities.

BACKGROUND: South Africa has a history of low breastfeeding rates among women with and without Human Immunodeficiency Virus (HIV). In this study, we assessed infant feeding knowledge, perceptions and practices among pregnant and postpartum women with and without HIV, in the context of changes in infant feeding and Prevention of Mother-to-Child Transmission of HIV (PMTCT) guidelines. METHODS: This was a cross-sectional survey conducted from April 2014 to March 2015 in 10 healthcare facilities in Johannesburg, South Africa. A total of 190 pregnant and 180 postpartum women (74 and 67, respectively, were HIV positive) were interviewed using a semi-structured questionnaire. Multiple regression analyses assessed factors associated with an intention to exclusively breastfeed, and exclusive breastfeeding of infants less than six months of age. RESULTS: Women with HIV had better overall knowledge on safe infant feeding practices, both in general and in the context of HIV infection. There were however gaps in knowledge among women with and without HIV. Information from healthcare facilities was the main source of information for all groups of women in the study. A greater percentage of women without HIV 80.9% (93/115), reported an intention to exclusively breastfeed, compared to 64.9% (48/74) of women with HIV, p = 0.014. Not having HIV was positively associated with a reported intention to breastfeed, Adjusted Odds Ratio (AOR) 3.60, 95% CI 1.50, 8.62. Other factors associated with a reported intention to exclusively breastfeed were prior breastfeeding experience and higher knowledge scores on safe infant feeding practices in the context of HIV infection. Among postpartum women, higher scores on general knowledge of safe infant feeding practices were positively associated with reported exclusive breastfeeding, AOR 2.18, 95% CI 1.52, 3.12. Most women perceived that it was difficult to exclusively breastfeed and that cultural factors were a barrier to exclusive breastfeeding. CONCLUSIONS: While a greater proportion of women are electing to breastfeed, HIV infection and cultural factors remain an important influence on safe infant feeding practices. Healthcare workers are the main source of information, and highlight the need for accurate and consistent messaging for both women with and without HIV.

Serotype-specific acquisition and loss of group B streptococcus recto-vaginal colonization in late pregnancy.

BACKGROUND: Maternal recto-vaginal colonization with Group B Streptococcus (GBS) and consequent vertical transmission to the newborn predisposes neonates to early-onset invasive GBS disease. This study aimed to determine the acquisition and loss of serotype-specific recto-vaginal GBS colonization from 20-37+ weeks of gestational age. METHODS: Vaginal and rectal swabs were collected from HIV-uninfected women at 20-25 weeks of gestation age and at 5-6 weekly intervals thereafter. Swabs were cultured for GBS and isolates were serotyped by latex agglutination. Serologically non-typable isolates and pilus islands were characterized by PCR. RESULTS: The prevalence of recto-vaginal GBS colonization was 33.0%, 32.7%, 28.7% and 28.4% at 20-25 weeks, 26-30 weeks, 31-35 weeks and 37+ weeks of gestational age, respectively. The most common identified serotypes were Ia (39.2%), III (32.8%) and V (12.4%). Of 507 participants who completed all four study visits, the cumulative overall recto-vaginal acquisition rate of new serotypes during the study was 27.9%, including 11.2%, 8.2% and 4.3% for serotypes Ia, III and V, respectively. Comparing the common colonizing serotypes, serotype III was more likely to be associated with persistent colonization throughout the study (29%) than Ia (18%; p = 0.045) or V (6%; p = 0.002). The median duration of recto-vaginal GBS colonization for serotype III was 6.35 weeks, which was longer than other serotypes. Pilus island proteins were detected in all GBS isolates and their subtype distribution was associated with specific serotypes. CONCLUSION: South African pregnant women have a high prevalence of GBS recto-vaginal colonization from 20 weeks of gestational age onwards, including high GBS acquisition rates in the last pregnancy-trimesters. There are differences in specific-serotype colonization patterns during pregnancy.

Risk factors for neonatal sepsis and perinatal death among infants enrolled in the prevention of perinatal sepsis trial, Soweto, South Africa.

BACKGROUND: Factors associated with neonatal sepsis, an important cause of child mortality, are poorly described in Africa. We characterized factors associated with early-onset (days 0-2 of life) and late-onset (days 3-28) -sepsis and perinatal death among infants enrolled in the Prevention of Perinatal Sepsis Trial (NCT00136370 at ClinicalTrials.gov), Soweto, South Africa. METHODS: Secondary analysis of 8011 enrolled mothers and their neonates. Prenatal and labor records were abstracted and neonatal wards were monitored for hospitalized Prevention of Perinatal Sepsis-enrolled neonates. Endpoint definitions required clinical and laboratory signs. All univariate factors associated with endpoints at P < 0.15 were evaluated using multivariable logistic regression. RESULTS: About 10.5% (837/8011) of women received intrapartum antibiotic prophylaxis; 3.8% of enrolled versus 15% of hospital births were preterm. Among 8129 infants, 289 had early-onset sepsis, 34 had late-onset sepsis, 49 had culture-confirmed neonatal sepsis and 71 died in the perinatal period. Factors associated with early-onset sepsis included preterm delivery [adjusted relative risk (aRR) = 2.6; 95% confidence interval (CI): 1.4-4.8]; low birth weight (<1500 g: aRR = 6.5, 95% CI: 2.4-17.3); meconium-stained amniotic fluid (MSAF) (aRR = 2.8, 95% CI: 2.2-3.7) and first birth (aRR = 1.8; 95% CI: 1.4-2.3). Preterm, low birth weight, MSAF and first birth were similarly associated with perinatal death and culture-confirmed sepsis. MSAF (aRR = 2.4, 95% CI: 1.1-5.0) was associated with late-onset sepsis. CONCLUSIONS: Preterm and low birth weight were important sepsis risk factors. MSAF and first birth were also associated with sepsis and death, warranting further exploration. Intrapartum antibiotic prophylaxis did not protect against all-cause sepsis or death, underscoring the need for alternate prevention strategies.

Confidential enquiries into hypoxic ischaemic encephalopathy.

Hypoxic ischaemic encephalopathy (HIE) may be regarded as a near miss marker for perinatal death resulting from intrapartum hypoxia. Considering the serious long-term consequences of HIE and issues of blame and liability for clinicians, regional or national audit of HIE might best be done using confidential enquiries. These are conducted by independent multidisciplinary panels, and should identify weaknesses in delivery of health care. A confidential enquiry into HIE may determine intrapartum factors that could have caused the poor outcome. It should also consider the role of associated preconceptual and antepartum factors, which may predispose the fetus to intrapartum damage. The enquiry should also assess avoidable factors and suboptimal care. These may involve patient- and family-related problems, administration-related suboptimal care, and health worker-related suboptimal care. The dissemination of the results of confidential enquiries should result in an improvement in quality of health care, including better allocation of health resources and health worker education.