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.

Calcium supplementation to prevent pre-eclampsia: protocol for an individual participant data meta-analysis, network meta-analysis and health economic evaluation.

INTRODUCTION: Low dietary calcium intake is a risk factor for pre-eclampsia, a major contributor to maternal and perinatal mortality and morbidity worldwide. Calcium supplementation can prevent pre-eclampsia in women with low dietary calcium. However, the optimal dose and timing of calcium supplementation are not known. We plan to undertake an individual participant data (IPD) meta-analysis of randomised trials to determine the effects of various calcium supplementation regimens in preventing pre-eclampsia and its complications and rank these by effectiveness. We also aim to evaluate the cost-effectiveness of calcium supplementation to prevent pre-eclampsia. METHODS AND ANALYSIS: We will identify randomised trials on calcium supplementation before and during pregnancy by searching major electronic databases including Embase, CINAHL, MEDLINE, CENTRAL, PubMed, Scopus, AMED, LILACS, POPLINE, AIM, IMSEAR, ClinicalTrials.gov and the WHO International Clinical Trials Registry Platform, without language restrictions, from inception to February 2022. Primary researchers of the identified trials will be invited to join the International Calcium in Pregnancy Collaborative Network and share their IPD. We will check each study's IPD for consistency with the original authors before standardising and harmonising the data. We will perform a series of one-stage and two-stage IPD random-effect meta-analyses to obtain the summary intervention effects on pre-eclampsia with 95% CIs and summary treatment-covariate interactions (maternal risk status, dietary intake, timing of intervention, daily dose of calcium prescribed and total intake of calcium). Heterogeneity will be summarised using tau2, I2 and 95% prediction intervals for effect in a new study. Sensitivity analysis to explore robustness of statistical and clinical assumptions will be carried out. Minor study effects (potential publication bias) will be investigated using funnel plots. A decision analytical model for use in low-income and middle-income countries will assess the cost-effectiveness of calcium supplementation to prevent pre-eclampsia. ETHICS AND DISSEMINATION: No ethical approvals are required. We will store the data in a secure repository in an anonymised format. The results will be published in peer-reviewed journals. PROSPERO REGISTRATION NUMBER: CRD42021231276.

Preliminary efficacy, feasibility and safety of intra-umbilical oxytocin to reduce the time to placental delivery at caesarean section: an exploratory randomized trial.

Background: Delayed placental separation either after vaginal birth or caesarean birth is an important cause of postpartum haemorrhage, among other causes such as uterine atony. Intra-umbilical oxytocin has been shown to reduce the time to placental delivery after vaginal birth. However, the efficacy of intra-umbilical oxytocin to reduce the time to placental delivery following caesarean section birth is not known. Objectives: To explore the preliminary efficacy, feasibility and safety of intra-umbilical oxytocin to reduce the time to placental delivery at caesarean section. Methods: A double-blind, placebo-controlled, exploratory randomized clinical trial was conducted at a tertiary hospital in the Eastern Cape Province, South Africa. A total of 66 women undergoing elective caesarean section were enrolled in the study and randomized into oxytocin group (n = 33) receiving an intra-umbilical infusion of 20 units of oxytocin in 30ml saline, and placebo group (n = 33) receiving an intra-umbilical infusion of 30ml saline. Data were analysed using Epi Info and RevMan software. Preliminary efficacy was assessed by examining the time elapsed from birth of the baby to complete delivery of the placenta; blood loss more than 500 ml; the need for manual removal of the placenta; and the completeness of the placenta. Feasibility was determined by observing the successful insertion of the catheter and injection of the solution. Safety was evaluated by investigating adverse effects of the procedure. Results: Four women (12%) in the placebo group had a delayed placental delivery compared to one (3%) in the oxytocin group. The mean time from birth to placental delivery was 159 (SD 61) seconds in the placebo group and 143 (SD 45) seconds in the oxytocin group. There was no statistically significant difference between the two groups. Feasibility of the procedure was confirmed by successful insertion of the catheter and injection of the majority of the solution in all 66 cases. No adverse effects of the procedure were identified. Conclusion: Administration of intra-umbilical oxytocin is feasible, safe and has potential to reduce the time of placental delivery at caesarean section. Further studies involving larger sample sizes are justified.

Foley Catheter Tourniquet for Uncontrollable Extra-Uterine Placental Hemorrhage: Description of a Novel Surgical Technique.

INTRODUCTION: Hemorrhage from a partially or fully detached placenta with an advanced abdominal pregnancy can be profuse and catastrophic. The general approach to placental management is removal of "all or nothing." In the event of acute hemorrhage, attempts to achieve hemostasis quickly are critical. We have found a Foley catheter tourniquet to be useful to control placental hemorrhage or as a temporary tourniquet applied around structures surrounding the implantation site to aid placental removal. We report use of the technique on 4 occasions with good surgical outcomes. CASE PRESENTATION: We report the case of a 33-year-old primigravid woman admitted at term with ultrasound diagnosis of breech presentation and placenta previa grade 4. Her preoperative clinical assessment, however, raised suspicion of an abdominal pregnancy. At laparotomy, a live female infant was delivered from the extra-uterine gestation sac, weighing 3,640 g and with Apgar scores of 7 and 6 at 1 and 5 min, respectively. Following delivery, there was profuse bleeding from the partially detached distal portion of the placenta that derived a rich blood supply from the poorly accessible posterior pelvic wall. We applied a novel, simple, and effective surgical technique for minimizing blood loss from the partially detached placenta using a Foley's catheter tourniquet that was applied between the detached and still attached parts of the placenta. The tourniquet was left in situ and removed at laparotomy 4 days later. The placenta was not removed. The mother and baby did well postoperatively and were discharged after 10 and 21 days, respectively, in good condition. The surgical technique was used in 3 additional cases with good clinical outcomes. DISCUSSION: Use of a Foley catheter as an intraoperative tourniquet has become accepted as a useful technique in obstetric and gynecological surgery. We describe a simple life-saving technique of applying a Foley tourniquet across a partially detached placenta following an advanced extra-uterine pregnancy to control acute hemorrhage. CONCLUSION: We recommend that surgeons keep in mind the option of intraoperative tourniquets when faced with uncontrollable bleeding as a short-term or medium-term temporizing measure.

Demographic, clinical and behavioural determinants of HIV serostatus non-disclosure to sex partners among HIV-infected pregnant women in the Eastern Cape, South Africa.

OBJECTIVES: Drawing from a baseline sample of a cohort study, the study examines the extent and correlates of serostatus non-disclosure to sex partners and family members, and reasons for non-disclosure among HIV-infected pregnant women in the Eastern Cape Province, South Africa. METHODS: This longitudinal cohort study recruited 1709 pregnant women living with HIV who attended three of the largest maternity centres in the Eastern Cape, South Africa, for delivery between September 2015 and May 2016. Relevant items on demographics, serostatus awareness, disclosure to sex partners and family members, and lifestyle behaviours were obtained using structured interviews. Age-stratified binary logistic regression models were used to determine the significant correlates of non-disclosure among the participants. RESULTS: A higher rate of HIV serostatus non-disclosure to sex partners (25.6%) in comparison to family members (20%) was reported by the participants. Younger age, not living with partners and alcohol use were significantly associated with non-disclosure of HIV serostatus to sex partners. Non-disclosure of HIV serostatus to sex partners was significantly (p<0.05) associated with poor adherence to the highly active anti-retroviral therapy (HAART), failure to keep clinic appointments and high viral load at the delivery of the baby. Perceived fear of intimate partner violence, fear of rejection, guilt of not disclosing at the onset of the relationship, sex partner's non-disclosure of HIV serostatus, and guilt of unfaithfulness were some of the reasons for non-disclosure of HIV serostatus to sex partners. CONCLUSIONS: Non-disclosure of HIV serostatus is a public health concern with serious implications for both mother-to-child transmission, as well as horizontal transmission, in our setting. Strategic efforts toward ending the epidemic of HIV and AIDS in South Africa should address the sociocultural and behavioural determinants of non-disclosure.

Onsite midwife-led birth units (OMBUs) for care around the time of childbirth: a systematic review.

INTRODUCTION: To ensure timely access to comprehensive emergency obstetric care in low- and middle-income countries, a number of interventions have been employed. This systematic review assesses the effects of onsite midwife-led birth units (OMBUs) embedded within hospitals which provide comprehensive emergency obstetric and newborn care. METHODS: Both interventional and observational studies that compared OMBUs with standard medical-led obstetric care were eligible for inclusion. Cochrane Central Register of Controlled Trials, PubMed/Medline, EMBASE, CINAHL, Science Citation and Social Sciences Citation Index, Global Health Library and one Chinese database were searched. Meta-analysis was conducted to synthesise data from randomised controlled trials (RCTs). Findings of observational studies were summarised by forest plots with brief narratives. RESULTS: Three RCTs, one controlled before-and-after study and six cohort studies were included. There were no or very few maternal and perinatal deaths in either OMBUs or standard obstetric units, with no significant differences between the two. Women giving birth in OMBUs were less likely to use epidural analgesia (risk ratio (RR) 0.67, 95% CI 0.55 to 0.82; three trials, n=2431). The UK national cohort study and two other cohorts in China and Nepal found less oxytocin augmentation, more spontaneous vaginal deliveries, fewer caesarean sections and fewer episiotomies performed in OMBUs than in standard obstetric units. These differences were not statistically significant in RCTs and the remaining cohorts. One study investigated satisfaction with midwife-led birth care among women and midwives, with positive findings in both groups favouring OMBUs. In addition, two studies found that the total cost of birth was lower in OMBUs than in standard obstetric units. CONCLUSIONS: OMBUs could be an alternative model for providing safe and cost-effective childbirth care, which may be particularly important in low- and middle-income countries to meet the growing demand for facility-based birth for low-risk women and improve efficiency of health systems.

Audit of a new model of birth care for women with low risk pregnancies in South Africa: the primary care onsite midwife-led birth unit (OMBU).

BACKGROUND: South Africa's health system is based on the primary care model in which low-risk maternity care is provided at community health centres and clinics, and 'high-risk' care is provided at secondary/tertiary hospitals. This model has the disadvantage of delays in the management of unexpected intrapartum complications in otherwise low-risk pregnancies, therefore, there is a need to re-evaluate the models of birth care in South Africa. To date, two primary care onsite midwife-led birth units (OMBUs) have been established in the Eastern Cape. OMBUs are similar to alongside midwifery units but have been adapted to the South African health system in that they are staffed, administered and funded by the primary care service. They allow women considered to be at 'low risk' to choose between birth in a community health centre and birth in the OMBU. METHODS: The purpose of this audit was to evaluate the impact of establishing an OMBU at Frere Maternity Hospital in East London, South Africa, on maternity services. We conducted an audit of routinely collected data from Frere Maternity Hospital over two 12 month periods, before and after the OMBU opened. Retrospectively retrieved data included the number of births, maternal and perinatal deaths, and mode of delivery. RESULTS: After the OMBU opened at Frere Maternity Hospital, the total number of births on the hospital premises increased by 16%. The total number of births in the hospital obstetric unit (OU) dropped by 9.3%, with 1611 births out of 7375 (22%) occurring in the new OMBU. The number of maternal and perinatal deaths was lower in the post-OMBU period compared with the pre-OMBU period. These improvements cannot be assumed to be the result of the intervention as observational studies are prone to bias. CONCLUSIONS: The mortality data should be interpreted with caution as other factors such as change in risk profile may have contributed to the death reductions. There are many additional advantages for women, hospital staff and primary care staff with this model, which may also be more cost-effective than the standard (freestanding) primary care model.

Caesarean section wound infiltration with local anaesthesia for postoperative pain relief - any benefit?

Delivery by caesarean section (CS) is becoming more frequent. Childbirth is an emotion-filled event, and the mother needs to bond with her baby as early as possible. Any intervention that leads to improvement in pain relief is worthy of investigation. Local anaesthetics have been employed as an adjunct to other methods of postoperative pain relief, but reports on the effectiveness of this strategy are conflicting. This review attempted to assess the effects of local anaesthetic agent wound infiltration and/or abdominal nerve blocks on pain after CS and the mother's well-being and interaction with her baby. Methods. We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (April 2009).The selection criteria were randomised controlled trials of local analgesia during CS to reduce pain afterwards. Twenty studies (1 150 women) were included. Results. Women who had wound infiltration after CS performed under regional analgesia had a decrease in morphine consumption at 24 hours compared with placebo (morphine dose -1.70 mg; 95% confidence interval (CI) -2.75 to -0.94). Women who had wound infiltration and peritoneal spraying with local anaesthetic after CS under general anaesthesia (1 study, 100 participants) had a reduced need for opioid rescue (risk ratio (RR) 0.51; 95% CI 0.38 to 0.69). The numerical pain score (0 -10) within the first hour was also reduced (mean difference (MD) -1.46; 95% CI -2.60 to -0.32). Women with regional analgesia who had local anaesthetic and non-steroidal anti-inflammatory cocktail wound infiltration consumed less morphine (1 study, 60 participants; MD -7.40 mg; 95% CI -9.58 to -5.22) compared with those who had local anaesthetic control. Women who had regional analgesia with abdominal nerve blocks had decreased opioid consumption (4 studies, 175 participants; MD -25.80 mg; 95% CI -50.39 to -5.37). For outcome in terms of the visual analogue pain score (0 - 10) over 24 hours, no advantage was demonstrated in the single study of 50 participants who had wound infiltration with a mixture of local analgesia and narcotics versus local analgesia. Conclusions. Local anaesthetic infiltration and abdominal nerve blocks as adjuncts to regional analgesia and general anaesthesia are of benefit in CS by reducing opioid consumption. Non-steroidal anti-inflammatory drugs may provide additional pain relief.

Interventions for leg edema and varicosities in pregnancy. What evidence?

Leg oedema from venous insufficiency is not dangerous but it can cause women symptoms such as pain, feelings of heaviness, night cramps and paraesthesiae. Leg oedema can be a sign of pre-eclampsia when associated with raised blood pressure or proteinuria. The objective of this review was to assess the effects of treatment to relieve the symptoms associated with varicosity in pregnancy and to reduce leg oedema. We searched the Cochrane Pregnancy and Childbirth Group trials register in October 2004 for randomised trials of any form of treatment for varicosity and or leg oedema in pregnancy. Trial quality was assessed and data were extracted. Four trials of three different treatments were included. In one trial, women given rutoside capsules in the last 3 months of pregnancy noted an improvement in symptoms compared with placebo (relative risk 0.54 95% CI 0.32, 0.89). They had a decrease in ankle circumference at 36 weeks' gestation after 8 weeks of treatment, while women given placebo had a small increase. In one trial, women with ankle oedema had a small non-significant reduction in lower leg volume when treated with external pneumatic intermittent compression for 30 min. In another trial compression stockings prophylactically reduced the emergence of leg symptoms but not venous varicosities (relative risk 0.74 95% CI 0.59, 0.93). Lymphatic reflexology was studied in too few women to draw conclusions. In conclusions, rutosides appear to relieve symptoms of venous insufficiency in late pregnancy. However, it is not known if the drug is safe in pregnancy. External pneumatic compression appears to reduce ankle swelling and compression stockings reduce leg symptoms but not varicose veins.