A research agenda to improve incidence and outcomes of assisted vaginal birth.

Access to emergency obstetric care, including assisted vaginal birth and caesarean birth, is crucial for improving maternal and childbirth outcomes. However, although the proportion of births by caesarean section has increased during the last few decades, the use of assisted vaginal birth has declined. This is particularly the case in low- and middle-income countries, despite an assisted vaginal birth often being less risky than caesarean birth. We therefore conducted a three-step process to identify a research agenda necessary to increase the use of, or reintroduce, assisted vaginal birth: after conducting an evidence synthesis, which informed a consultation with technical experts who proposed an initial research agenda, we sought and incorporated the views of women's representatives of this agenda. This process has allowed us to identify a comprehensive research agenda, with topics categorized as: (i) the need to understand women's perceptions of assisted vaginal birth, and provide appropriate and reliable information; (ii) the importance of training health-care providers in clinical skills but also in respectful care, effective communication, shared decision-making and informed consent; and (iii) the barriers to and facilitators of implementation and sustainability. From women's feedback, we learned of the urgent need to recognize labour, childbirth and postpartum experiences as inherently physiological and dignified human processes, in which interventions should only be implemented if necessary. The promotion and/or reintroduction of assisted vaginal birth in low-resource settings requires governments, policy-makers and hospital administrators to support skilled health-care providers who can, in turn, respectfully support women in labour and childbirth.

L'accès aux soins obstétriques d'urgence, y compris l'accouchement vaginal assisté et la césarienne, est essentiel pour améliorer les effets de la maternité et de l'accouchement. Toutefois, bien que la proportion de césariennes ait augmenté ces dernières décennies, le recours à l'accouchement vaginal assisté a diminué. C'est particulièrement le cas dans les pays à revenu faible ou intermédiaire, bien que l'accouchement vaginal assisté soit souvent moins risqué qu'une césarienne. Nous avons donc mené un processus en trois étapes afin d'imaginer un programme de recherche qui permettrait d'augmenter le recours à l'accouchement vaginal assisté ou de le réintroduire. Après avoir réalisé une synthèse des données probantes, qui a servi de base à une consultation avec des experts techniques qui ont proposé un programme de recherche initial, nous avons sollicité et incorporé les avis des représentantes des femmes pour ce programme. Ce processus nous a permis d'imaginer un programme de recherche complet, avec des sujets classés comme suit: (i) la nécessité de comprendre la perception qu'ont les femmes de l'accouchement vaginal assisté et de fournir des informations appropriées et fiables; (ii) l'importance de la formation des prestataires de soins de santé en matière de compétences cliniques, mais aussi de respect dans les soins de santé, de communication efficace, de prise de décision partagée et de consentement éclairé; ou (iii) les obstacles à la mise en œuvre et à la durabilité et les facteurs qui les facilitent. Les réactions de femmes nous ont appris qu'il était urgent de reconnaître que l'accouchement, la naissance et le post-partum sont des processus humains intrinsèquement physiologiques et dignes au cours desquels les interventions ne devraient être mises en œuvre qu'en cas de nécessité. La promotion et/ou la réintroduction de l'accouchement vaginal assisté dans les régions à faibles ressources nécessitent que les pouvoirs publics, les décideurs politiques et les administrations d'hôpitaux soutiennent les prestataires de soins de santé qualifiés, qui pourront à leur tour soutenir respectueusement les femmes pendant l'accouchement.

El acceso a la atención obstétrica de emergencia, incluido el parto vaginal asistido y el parto por cesárea, es crucial para mejorar los resultados de la maternidad y el parto. No obstante, aunque el porcentaje de partos por cesárea ha aumentado en las últimas décadas, el uso del parto vaginal asistido ha disminuido. Esto ocurre especialmente en los países de ingresos bajos y medios, a pesar de que un parto vaginal asistido suele ser menos arriesgado que un parto por cesárea. Por lo tanto, llevamos a cabo un proceso de tres pasos para identificar un programa de investigación necesario para aumentar el uso del parto vaginal asistido o volver a incorporarlo: tras realizar una síntesis de la evidencia, que sirvió de base para una consulta con expertos técnicos que propusieron un programa de investigación inicial, buscamos e integramos las opiniones de las representantes de las mujeres sobre este programa. Este proceso nos ha permitido identificar un programa de investigación exhaustivo, con temas categorizados como: (i) la necesidad de comprender las percepciones de las mujeres sobre el parto vaginal asistido, y proporcionar información adecuada y fiable; (ii) la importancia de formar a los profesionales sanitarios en habilidades clínicas, pero también en atención respetuosa, comunicación efectiva, toma de decisiones compartida y consentimiento informado; o (iii) las barreras y los facilitadores de la implementación y la sostenibilidad. A partir de las opiniones de las mujeres, nos enteramos de la urgente necesidad de reconocer las experiencias del parto, el alumbramiento y el posparto como procesos humanos inherentemente fisiológicos y dignos, en los que las intervenciones solo deben aplicarse si son necesarias. La promoción o la reincoporación del parto vaginal asistido en regiones de escasos recursos exige que los gobiernos, los responsables de formular políticas y los administradores de hospitales apoyen a los profesionales sanitarios capacitados que, a su vez, pueden ayudar a las mujeres en el trabajo de parto y el alumbramiento de manera respetuosa.

Implementation of continuous-wave Doppler ultrasound to detect the high-risk foetus in the low-risk mother: lessons from South Africa.

INTRODUCTION: Detecting the risk of stillbirth during pregnancy remains a challenge. Continuous-wave Doppler ultrasound (CWDU) can be used to screen for placental insufficiency, which is a major cause of stillbirths in low-risk pregnant women. This paper describes the adaptation and implementation of screening with CWDU and shares critical lessons for further rollout. Screening of 7088 low-risk pregnant women with Umbiflow™ (a CWDU device) was conducted in 19 antenatal care clinics at nine study sites in South Africa. Each site comprised a catchment area with a regional referral hospital and primary healthcare antenatal clinics. Women with suspected placental insufficiency as detected by CWDU were referred for follow-up at the hospital. A 35-43% reduction in stillbirths was recorded. METHODS: The authors followed an iterative reflection process using the field and meeting notes to arrive at an interpretation of the important lessons for future implementation of new devices in resource-constrained settings. RESULTS: Key features of the implementation of CWDU screening in pregnancy combined with high-risk follow-up are described according to a six-stage change framework: create awareness; commit to implement; prepare to implement; implement; integrate into routine practice; and sustain practice. Differences and similarities in implementation between the different study sites are explored. Important lessons include stakeholder involvement and communication and identifying what would be needed to integrate screening with CWDU into routine antenatal care. A flexible implementation model with four components is proposed for the further rollout of CWDU screening. CONCLUSIONS: This study demonstrated that the integration of CWDU screening into routine antenatal care, combined with standard treatment protocols at a higher-level referral hospital, can be achieved with the necessary resources and available maternal and neonatal facilities. Lessons from this study could contribute to future scale-up efforts and help to inform decisions on improving antenatal care and pregnancy outcomes in low- and middle-income countries.

Integrated growth assessment in the first 1000 d of life: an interdisciplinary conceptual framework.

OBJECTIVES: Prenatal growth affects short- and long-term morbidity, mortality and growth, yet communication between prenatal and postnatal healthcare teams is often minimal. This paper aims to develop an integrated, interdisciplinary framework for foetal/infant growth assessment, contributing to the continuity of care across the first 1000 d of life. DESIGN: A multidisciplinary think-tank met regularly over many months to share and debate their practice and research experience related to foetal/infant growth assessment. Participants' personal practice and knowledge were verified against and supplemented by published research. SETTING: Online and in-person brainstorming sessions of growth assessment practices that are feasible and valuable in resource-limited, low- and middle-income country (LMIC) settings. PARTICIPANTS: A group of obstetricians, paediatricians, dietitians/nutritionists and a statistician. RESULTS: Numerous measurements, indices and indicators were identified for growth assessment in the first 1000 d. Relationships between foetal, neonatal and infant measurements were elucidated and integrated into an interdisciplinary framework. Practices relevant to LMIC were then highlighted: antenatal Doppler screening, comprehensive and accurate birth anthropometry (including proportionality of weight, length and head circumference), placenta weighing and incorporation of length-for-age, weight-for-length and mid-upper arm circumference in routine growth monitoring. The need for appropriate, standardised clinical records and corresponding policies to guide clinical practice and facilitate interdisciplinary communication over time became apparent. CONCLUSIONS: Clearer communication between prenatal, perinatal and postnatal health care providers, within the framework of a common understanding of growth assessment and a supportive policy environment, is a prerequisite to continuity of care and optimal health and development outcomes.

From Pre-Implementation to Institutionalization: Lessons From Sustaining a Perinatal Audit Program in South Africa.

INTRODUCTION: Maternal and perinatal death surveillance and response (MPDSR), or related forms of maternal and perinatal death audits, can strengthen health systems. We explore the history of initiating, scaling up, and institutionalizing a national perinatal audit program in South Africa. METHODS: Data collection involved 56 individual interviews, a systematic document review, administration of a semistructured questionnaire, and 10 nonparticipant observations of meetings related to the perinatal audit program. Fieldwork and data collection in the subdistricts occurred from September 2019 to March 2020. Data analysis included thematic content analysis and application of a tool to measure subdistrict-level implementation. This study expands on case study research applied to 5 Western Cape subdistricts with long histories of implementation. RESULTS: Although established in the early 1990s, the perinatal audit program was not integrated into national policy and guidelines until 2012 but was then excluded from policy in 2021. A network of national and subnational structures that benefited from a continuity of actors evolved and interacted to support uptake and implementation. Intentional efforts to demonstrate impact and enable local adaptation allowed for more ownership and buy-in. Implementation requires continuous efforts. Even in 5 subdistricts with long histories of practice, we found operational gaps, such as incomplete meeting minutes, signaling a need for strengthening. Nevertheless, the tool used to measure implementation may require revisions, particularly in settings with institutionalized practice. CONCLUSION: This article provides lessons on how to initiate, expand, and strengthen perinatal audit. Despite a long history of implementation, the perinatal audit program in South Africa cannot be assumed to be indefinitely sustainable or final in its current form. To monitor uptake and sustainability of MPDSR, including perinatal audit, we need research approaches that allow exploration of context, local adaptation, and underlying issues that support sustainability, such as relationships, leadership, and trust.

Preventing antenatal stillbirths: An innovative approach for primary health care.

BACKGROUND: In South Africa (SA), approximately 16 000 stillbirths occur annually. Most are classified as unexplained and occur in district hospitals. Many of these deaths may be caused by undetected foetal growth restriction. Continuous wave Doppler ultrasound of the umbilical artery (CWDU-UmA) is a simple method for assessing placental function. This screening method may detect the foetus at risk of dying and growth-restricted foetuses, allowing for appropriate management. METHODS: A cohort study was conducted across South Africa. Pregnant women attending primary health care clinics at 28-34 weeks gestation were screened using CWDU-UmA. Women not screened at those antenatal clinics served as control group 1. Control group 2 consisted of the subset of control group 1 with women detected with antenatal complications excluded. Women with foetuses identified with an abnormal CWDU-UmA test were referred and managed according to a standardised protocol. A comparison between the study and control groups was performed. RESULTS: The study group consisted of 6536 pregnancies, and there were 66 stillbirths (stillbirth rate [SBR]: 10.1/1000 births). In control group 1, there were 193 stillbirths in 10 832 women (SBR: 17.8/1000 births), and in control group 2, 152 stillbirths in 9811 women (SBR: 15.5/1000 births) (risk ratio: 0.57, 95% confidence intervals: 0.29-0.85 and 0.65, 0.36-0.94, respectively). CONCLUSION: Screening a low-risk pregnant population identified the low-risk mother with a high-risk foetus, and acting on the information as described was associated with a significant reduction (35% - 43%) in stillbirths. This demonstrates a step-change reduction in stillbirths and warrants screening in SA.

Antenatal Doppler screening for fetuses at risk of adverse outcomes: a multicountry cohort study of the prevalence of abnormal resistance index in low-risk pregnant women.

INTRODUCTION: Few interventions exist to address the high burden of stillbirths in apparently healthy pregnant women in low- and middle-income countries (LMICs). To establish whether a trial on the impact of routine Doppler screening in a low-risk obstetric population is warranted, we determined the prevalence of abnormal fetal umbilical artery resistance indices among low-risk pregnant women using a low-cost Doppler device in five LMICs. METHODS: We conducted a multicentre, prospective cohort study in Ghana, India, Kenya, Rwanda and South Africa. Trained nurses or midwives performed a single, continuous-wave Doppler screening using the Umbiflow device for low-risk pregnant women (according to local guidelines) between 28 and 34 weeks' gestation. We assessed the prevalence of abnormal (raised) resistance index (RI), including absent end diastolic flow (AEDF), and compared pregnancy and health service utilisation outcomes between women with abnormal RI versus those with normal RI. RESULTS: Of 7151 women screened, 495 (6.9%) had an abnormal RI, including 14 (0.2%) with AEDF. Caesarean section (40.8% vs 28.1%), labour induction (20.5% vs 9.0%) and low birth weight (<2500 g) (15.0% vs 6.8%) were significantly more frequent among women with abnormal RI compared with women with normal RI. Abnormal RI was associated with lower birth weights across all weight centiles. Stillbirth and perinatal mortality rates were similar between women with normal and abnormal RI. CONCLUSION: A single Doppler screening of low-risk pregnant women in LMICs using the Umbiflow device can detect a large number of fetuses at risk of growth restriction and consequent adverse perinatal outcomes. Many perinatal deaths could potentially be averted with appropriate intervention strategies. TRIAL REGISTRATION NUMBER: CTRI/2018/07/01486.

Portable continuous wave Doppler ultrasound for primary healthcare in South Africa: can the EUnetHTA Core Model guide evaluation before technology adoption?

BACKGROUND: This study had a threefold aim: to test the value of stakeholder involvement in HTA to reduce evidence gaps and interpret findings; and to assess a medical device by applying the EUnetHTA Core Model (CM) in South Africa and thus ultimately provide a first overview of evidence for potential widespread adoption of the technology in a primary health care (PHC) setting. Used in primary healthcare setting for obstetric use, the technology under assessment is a low-cost continuous wave Doppler ultrasound (DUS). METHODS: The scoping of the assessment was defined by involving policy makers in selecting the domains and corresponding questions relevant to the ultrasound and its use. Additionally, hospital managers were invited to respond to dichotomous questions on the criteria for procurement. To substantiate evidence obtained from an initial literature review, different stakeholders were identified and consulted. The evidence generated fromall steps was used to populate the high-ranked assessment elements of the CM. RESULTS: The HTA on continuous-wave DUS incorporated the evidence on organizational, ethical, and social value of its use together with effectiveness, safety, and cost-effectiveness of the technology. The domains on "health problem" and "safety" had a higher rank than the rest of the nine domains. Unexplained fetal mortality is the largest single contributor to perinatal deaths in South Africa. Pregnant women in PHC setting were examined using a continuous-wave DUS, after their routine antenatal visit. The healthcare professionals interviewed, indicated the benefit in the use of continuous-wave DUS in the PHC setting and the need for training. CONCLUSIONS: Collection and generation of evidence based on the HTA CM and the chosen decision criteria provided a generalized but structured guidance on the methodology. Several questions were not applicable for the technology and the context of its use and elimination of those that are inappropriate for the African context, resulted in a pragmatic solution. Engaging and consulting local stakeholders was imperative to understand the context, reduce evidence gaps, and address the uncertainties in the evidence, ultimately paving the way for technology adoption. Given the ongoing studies and the evolving evidence base, the potential of this technology should be reassessed.

Prevalence of abnormal umbilical arterial flow on Doppler ultrasound in low-risk and unselected pregnant women: a systematic review.

BACKGROUND: While Doppler ultrasound screening is beneficial for women with high-risk pregnancies, there is insufficient evidence on its benefits and harms in low- and unselected-risk pregnancies. This may be related to fewer events of abnormal Doppler flow, however the prevalence of absent or reversed end diastolic flow (AEDF or REDF) in such women is unknown. In this systematic review, we aimed to synthesise available data on the prevalence of AEDF or REDF. METHODS: We searched PubMed, Embase, CINAHL, CENTRAL and Global Index Medicus with no date, setting or language restrictions. All randomized or non-randomized studies reporting AEDF or REDF prevalence based on Doppler assessment of umbilical arterial flow > 20 weeks' gestation were eligible. Two authors assessed eligibility and extracted data on primary (AEDF and REDF) and secondary (fetal, perinatal, and neonatal mortality, caesarean section) outcomes, with results presented descriptively. RESULTS: A total of 42 studies (18,282 women) were included. Thirty-six studies reported zero AEDF or REDF cases. However, 55 AEDF or REDF cases were identified from just six studies (prevalence 0.08% to 2.13%). Four of these studies were in unselected-risk women and five were conducted in high-income countries. There was limited evidence from low- and middle-income countries. CONCLUSIONS: Evidence from largely observational studies in higher-income countries suggests that AEDF and REDF are rare among low- and unselected-risk pregnant women. There are insufficient data from lower-income countries and further research is required.

CLEVER maternity care: A before-and-after study of women's experience of childbirth in Tshwane, South Africa.

BACKGROUND: Birthing care matters to women and some women experience mistreatment during childbirth. AIM: To determine the effect the 'CLEVER Maternity Care' package, a multi-faceted intervention to improve respectful, quality obstetric care. SETTING: Ten midwife-led obstetric units in Tshwane health district, South Africa; five intervention and five control units. METHODS: We conducted an anonymous baseline and end-line survey to measure the change in women's perceptions and experiences of childbirth care after the implementation of the CLEVER package. A convenience sample of women returning for a postnatal follow-up visit was obtained at baseline (n = 653) and after implementation of CLEVER (n = 679). RESULTS: Six survey items were selected as proxies for respectful clinical care. There was no significant change in proportions of responses regarding one question, and with regard to patients receiving attention within 15 min of arrival, both the intervention and control group units showed a significant increase in positive responses (odds ratios of 8.4 and 6.1, respectively, and p values of 0.0001 and 0.0007). For the remaining four items (asking permission before doing an examination, positive communication, respectful treatment and overall satisfaction), only the intervention group showed a significant positive change (odds ratios ranging from 2.4 to 4.3; p ≤ 0.0018), with no significant change for the control group (odds ratios between 1.0 and 1.8; p ≥ 0.0736). CONCLUSION: After the implementation of CLEVER Maternity Care, women reported a more positive experience of childbirth. The CLEVER intervention is a potential strategy for addressing respectful, quality obstetric care that warrants further investigation.

An approach to hypertensive disorders in pregnancy for the primary care physician.

Hypertensive disorders in pregnancy (HDP) are a leading obstetric cause for maternal morbidity and mortality nationally as well as globally. The Saving Mothers is a report published every three years by the National Committee for Confidential Enquiry, which reports the trends in maternal deaths in South Africa. The last three Saving Mothers reports identified many gaps in the management of HDP and interventions to address these gaps were recommended. The recently published national guidelines on the management of HDP have highlighted approaches for the diagnosis, assessment and management of HDP. This article synthesises the national guidelines and provides approaches for the primary care physician working at the primary healthcare or the district hospital level. The algorithms provide easy clinical pathways once the correct assessment has been made.

CLEVER maternity care: a before-and-after study of women's experience of childbirth in Tshwane, South Africa

Background: Birthing care matters to women and some women experience mistreatment during childbirth. Aim: To determine the effect the 'CLEVER Maternity Care' package, a multi-faceted intervention to improve respectful, quality obstetric care. Setting: Ten midwife-led obstetric units in Tshwane health district, South Africa; five intervention and five control units. Methods: We conducted an anonymous baseline and end-line survey to measure the change in women's perceptions and experiences of childbirth care after the implementation of the CLEVER package. A convenience sample of women returning for a postnatal follow-up visit was obtained at baseline (n = 653) and after implementation of CLEVER (n = 679). Results: Six survey items were selected as proxies for respectful clinical care. There was no significant change in proportions of responses regarding one question, and with regard to patients receiving attention within 15 min of arrival, both the intervention and control group units showed a significant increase in positive responses (odds ratios of 8.4 and 6.1, respectively, and p values of 0.0001 and 0.0007). For the remaining four items (asking permission before doing an examination, positive communication, respectful treatment and overall satisfaction), only the intervention group showed a significant positive change (odds ratios ranging from 2.4 to 4.3; p ≤ 0.0018), with no significant change for the control group (odds ratios between 1.0 and 1.8; p ≥ 0.0736). Conclusion: After the implementation of CLEVER Maternity Care, women reported a more positive experience of childbirth. The CLEVER intervention is a potential strategy for addressing respectful, quality obstetric care that warrants further investigation

A before and after study of the impact on obstetric and perinatal outcomes following the introduction of an educational package of fetal heart rate monitoring education coupled with umbilical artery lactate sampling in a low resource setting labor ward in South Africa.

INTRODUCTION: Rates of cesarean section (CS) are increasing and abnormal fetal heart rate tracing and concern about consequent acidosis remain one of the most common indications for primary CS. Umbilical artery (UA) lactate sampling provides clinicians with point of care feedback on CTG interpretation and intrapartum care and may result in altered future practice. MATERIALS AND METHODS: From 3rd March - 12th November 2014 we undertook a before and after study in Pretoria, South Africa, to determine the impact of introducing a clinical package of fetal heart rate monitoring education and prompt feedback with UA cord lactate sampling, using a hand-held meter, on maternal and perinatal outcomes. RESULTS: Nine hundred thirty-six consecutive samples were analyzed (pre n = 374 and post n = 562). There was no difference in mean lactate (4.6 mmol/L [95%CI 4.4-4.8] compared with 4.9 mmol/L [95%CI 4.7-5.1], p = 0.089). Suspected fetal compromise was reduced in the post-intervention period: 30·2% vs 22·1%, aOR 0·71, 95% CI 0·52-0·96, p = 0·027. Cesarean section rates were significantly reduced in the univariate analysis: pre- 40·3% vs post-intervention 31·6% (p = 0·007). This reduction remained significant when adjusted for previous cesarean section, primiparity, maternal HIV infection and preterm birth (aOR 0·72, 95%CI 0·54-0·98, p = 0·035). Neonatal outcomes did not differ between the two groups. CONCLUSION: The introduction of a clinical practice package of fetal heart rate monitoring education combined with routine UA cord lactate sampling has the potential to reduce the cesarean section rate without increasing adverse neonatal outcomes in a low-resource setting.

Applying the international classification of diseases to perinatal mortality data, South Africa.

OBJECTIVE: To examine the feasibility of applying the International Classification of Diseases-perinatal mortality (ICD-PM) coding to an existing data set in the classification of perinatal deaths. METHODS: One author, a researcher with a non-clinical public health background, applied the ICD-PM coding system to South Africa's national perinatal mortality audit system, the Perinatal Problem Identification Program. The database for this study included all perinatal deaths (n = 26 810), defined as either stillbirths (of birth weight > 1000 g and after 28 weeks of gestation) or early neonatal deaths (age 0-7 days), that occurred between 1 October 2013 and 31 December 2016. A clinical obstetrician verified the coding. FINDINGS: The South African classification system does not include the timing of death; however, under the ICD-PM system, deaths could be classified as antepartum (n = 15 619; 58.2%), intrapartum (n = 3725; 14.0%) or neonatal (n = 7466; 27.8%). Further, the South African classification system linked a maternal condition to only 40.3% (10 802/26 810) of all perinatal deaths; this proportion increased to 68.9% (18 467/26 810) under the ICD-PM system. CONCLUSION: The main benefit of using the clinically relevant and user-friendly ICD-PM system was an enhanced understanding of the data, in terms of both timing of death and maternal conditions. We have also demonstrated that it is feasible to convert an existing perinatal mortality classification system to one which is globally comparable and can inform policy-makers internationally.

Impact of maternal HIV on umbilical cord lactate measurement at delivery in a South African labor ward.

OBJECTIVE: To assess umbilical artery lactate levels and perinatal outcomes among women with and without HIV infection. METHODS: The present prospective cohort study recruited women planning to undergo vaginal delivery at Kalafong Hospital, South Africa, between March 3 and November 12, 2014. Umbilical artery lactate levels were measured and perinatal outcome data were recorded. Outcome analyses were stratified by maternal HIV status, and a subgroup analysis was performed where women with a CD4 count below 350 × 106 cells/L were compared with women without HIV. RESULTS: In total, 936 women with singleton fetuses were enrolled. Maternal HIV status was available for 897 (95.8%) participants, of whom 202 (21.6%) had HIV infections. Overall, 186 (92.1%) women with HIV infections received prophylaxis or treatment. There was no difference between participants with and without HIV infections in the preterm delivery rate (P=0.770), mode of delivery (P=0.354), neonatal resuscitation rate (P=0.717), 1- or 5-minute Apgar scores below 7 (P=0.353), or the rate of having an umbilical artery lactate level above 5.45 mmol/L (P=0.301). Similarly, there were no differences in outcomes in the subgroup analysis of women with a CD4 count below 350 × 106 cells/L. CONCLUSION: Umbilical artery lactate levels and perinatal outcomes were found to be comparable between patients with and without HIV infections in a South African setting.

Odon device for instrumental vaginal deliveries: results of a medical device pilot clinical study.

BACKGROUND: A prolonged and complicated second stage of labour is associated with serious perinatal complications. The Odon device is an innovation intended to perform instrumental vaginal delivery presently under development. We present an evaluation of the feasibility and safety of delivery with early prototypes of this device from an early terminated clinical study. METHODS: Hospital-based, multi-phased, open-label, pilot clinical study with no control group in tertiary hospitals in Argentina and South Africa. Multiparous and nulliparous women, with uncomplicated singleton pregnancies, were enrolled during the third trimester of pregnancy. Delivery with Odon device was attempted under non-emergency conditions during the second stage of labour. The feasibility outcome was delivery with the Odon device defined as successful expulsion of the fetal head after one-time application of the device. RESULTS: Of the 49 women enrolled, the Odon device was inserted successfully in 46 (93%), and successful Odon device delivery as defined above was achieved in 35 (71%) women. Vaginal, first and second degree perineal tears occurred in 29 (59%) women. Four women had cervical tears. No third or fourth degree perineal tears were observed. All neonates were born alive and vigorous. No adverse maternal or infant outcomes were observed at 6-weeks follow-up for all dyads, and at 1 year for the first 30 dyads. CONCLUSIONS: Delivery using the Odon device is feasible. Observed genital tears could be due to the device or the process of delivery and assessment bias. Evaluating the effectiveness and safety of the further developed prototype of the BD Odon Device™ will require a randomized-controlled trial. TRIAL REGISTRATION: ANZCTR ACTRN12613000141741 Registered 06 February 2013. Retrospectively registered.

Quality of life 1 year after a maternal near-miss event.

OBJECTIVES: To evaluate quality of life (QoL) parameters among women categorized with a maternal near-miss during pregnancy. METHODS: The present prospective cohort study was conducted at a tertiary referral hospital in South Africa between April 1, 2013, and March 31, 2016. Patients who experienced maternal near-miss events were included and patients with uncomplicated low-risk pregnancies were enrolled as a control group. Various parameters were assessed using a WHO QoL questionnaire. RESULTS: The maternal near-miss and uncomplicated low-risk pregnancy (control) groups comprised 95 and 51 women. The maternal near-miss group scored lower than the control group in all four domains of the questionnaire (P<0.001). Overall, 42 (82%) women in the control group and 41 (43%) women in the maternal near-miss group desired future fertility (P<0.001). Women in the maternal near-miss group who had experienced perinatal loss scored lower in the physical health and well-being (P=0.009), psychological health and well-being (P=0.007), and environment (P=0.031) domains compared with women in the maternal near-miss group who experienced a live delivery. Nonetheless, QoL scores among women in the maternal near-miss group who had experienced perinatal loss remained lower than those reported by women in the control group (P<0.001). CONCLUSION: A maternal near-miss event during pregnancy was associated with reduced QoL, especially among women who had experienced perinatal loss.

It does matter where you come from: mothers' experiences of childbirth in midwife obstetric units, Tshwane, South Africa.

BACKGROUND: Health professionals are striving to improve respectful care for women, but they fall short in the domains of effective communication, respectful and dignified care and emotional support during labour. This study aimed to determine women's experiences of childbirth with a view to improving respectful clinical care practices in low-risk, midwife-led obstetric units in the Tshwane District Health District, South Africa. METHODS: A survey covering all midwife-led units in the district was conducted among 653 new mothers. An anonymous questionnaire was administered to mothers returning for a three-days-to-six-weeks postnatal follow-up visit. Mothers were asked about their experiences regarding communication, labour, clinical care and respectful care during confinement. An ANCOVA was performed to identify the socio-demographic variables that significantly predicted disrespectful care. Six items representing the different areas of experience were used in the analysis. RESULTS: Age, language, educational level and length of residence in the district were significantly associated with disrespectful care (p ≤ 0.01). Overall, the following groups of mothers reported more negative care experiences during labour: women between the ages of 17 and 24 years; women with limited formal education; and women from another province or a neighbouring country. Items which attracted fewer positive responses from participants were the following: 46% of mothers had been welcomed by name on arrival; 47% had been asked to give consent to a physical examination; and 39% had been offered food or water during labour. With regard to items related to respectful care, 54% of mothers indicated that all staff members had spoken courteously to them, 48% said they had been treated with a lot of respect, and 55% were completely satisfied with their treatment. CONCLUSION: There is a need to improve respectful care through interventions that are integrated into routine care practices in labour wards. To stop the spiral of abusive obstetric care, the care provided should be culturally sensitive and should address equity for the most vulnerable and underserved groups. All levels of the health care system should employ respectful obstetric care practices, matched with support for midwives and improved clinical governance in maternity facilities.

Pelvimetry for fetal cephalic presentations at or near term for deciding on mode of delivery.

BACKGROUND: Pelvimetry assesses the size of a woman's pelvis aiming to predict whether she will be able to give birth vaginally or not. This can be done by clinical examination, or by conventional X-rays, computerised tomography (CT) scanning, or magnetic resonance imaging (MRI). OBJECTIVES: To assess the effects of pelvimetry (performed antenatally or intrapartum) on the method of birth, on perinatal mortality and morbidity, and on maternal morbidity. This review concentrates exclusively on women whose fetuses have a cephalic presentation. SEARCH METHODS: We searched Cochrane Pregnancy and Childbirth Group's Trials Register (31 January 2017) and reference lists of retrieved studies. SELECTION CRITERIA: Randomised controlled trials (including quasi-randomised) assessing the use of pelvimetry versus no pelvimetry or assessing different types of pelvimetry in women with a cephalic presentation at or near term were included. Cluster trials were eligible for inclusion, but none were identified. DATA COLLECTION AND ANALYSIS: Two review authors independently assessed trials for inclusion and risk of bias, extracted data and checked them for accuracy. We assessed the quality of the evidence using the GRADE approach. MAIN RESULTS: Five trials with a total of 1159 women were included. All used X-ray pelvimetry to assess the pelvis. X-ray pelvimetry versus no pelvimetry or clinical pelvimetry is the only comparison included in this review due to the lack of trials identified that examined other types of radiological pelvimetry or that compared clinical pelvimetry versus no pelvimetry.The included trials were generally at high risk of bias. There is an overall high risk of performance bias due to lack of blinding of women and staff. Two studies were also at high risk of selection bias. We used GRADEpro software to grade evidence for our selected outcomes; for caesarean section we rated the evidence low quality and all the other outcomes (perinatal mortality, wound sepsis, blood transfusion, scar dehiscence and admission to special care baby unit) as very low quality. Downgrading was due to risk of bias relating to lack of allocation concealment and blinding, and imprecision of effect estimates.Women undergoing X-ray pelvimetry were more likely to have a caesarean section (risk ratio (RR) 1.34, 95% confidence interval (CI) 1.19 to 1.52; 1159 women; 5 studies; low-quality evidence). There were no clear differences between groups for perinatal outcomes: perinatal mortality (RR 0.53, 95% CI 0.19 to 1.45; 1159 infants; 5 studies; very low-quality evidence), perinatal asphyxia (RR 0.66, 95% CI 0.39 to 1.10; 305 infants; 1 study), and admission to special care baby unit (RR 0.20, 95% CI 0.01 to 4.13; 288 infants; 1 study; very low-quality evidence). Other outcomes assessed were wound sepsis (RR 0.83, 95% CI 0.26 to 2.67; 288 women; 1 study; very low-quality evidence), blood transfusion (RR 1.00, 95% CI 0.39 to 2.59; 288 women; 1 study; very low-quality evidence), and scar dehiscence (RR 0.59, 95% CI 0.14 to 2.46; 390 women; 2 studies; very low-quality evidence). Again, no clear differences were found for these outcomes between the women who received X-ray pelvimetry and those who did not. Apgar score less than seven at five minutes was not reported in any study. AUTHORS' CONCLUSIONS: X-ray pelvimetry versus no pelvimetry or clinical pelvimetry is the only comparison included in this review due to the lack of trials identified that used other types or pelvimetry (other radiological examination or clinical pelvimetry versus no pelvimetry). There is not enough evidence to support the use of X-ray pelvimetry for deciding on mode of delivery in women whose fetuses have a cephalic presentation. Women who undergo an X-ray pelvimetry may be more likely to have a caesarean section.Further research should be directed towards defining whether there are specific clinical situations in which pelvimetry can be shown to be of value. Newer methods of pelvimetry (CT, MRI) should be subjected to randomised trials to assess their value. Further trials of X-ray pelvimetry in cephalic presentations would be of value if large enough to assess the effect on perinatal mortality.