[Show abstract][Hide abstract] ABSTRACT: Background:
Strategies to prevent postnatal mother-to-child transmission of HIV-1 in Africa, including infant prophylaxis, have never been assessed past 6 months of breastfeeding, despite breastfeeding being recommended up to 12 months after birth. We aimed to compare the efficacy and safety of infant prophylaxis with the two drug regimens (lamivudine or lopinavir-ritonavir) to prevent postnatal HIV-1 transmission up to 50 weeks of breastfeeding.
We did a randomised controlled trial in four sites in Burkina Faso, South Africa, Uganda, and Zambia in children born to HIV-1-infected mothers not eligible for antiretroviral therapy (CD4 count >350 cells per μL). An independent researcher electronically generated a randomisation schedule; we then used sequentially numbered envelopes to randomly assign (1:1) HIV-1-uninfected breastfed infants aged 7 days to either lopinavir-ritonavir or lamivudine (paediatric liquid formulations, twice a day) up to 1 week after complete cessation of breastfeeding or at the final visit at week 50. We stratified the randomisation by country and used permuted blocks of four and six. We used a study label on drug bottles to mask participants, study physicians, and assessors to the treatment allocation. The primary outcome was infant HIV-1 infection between age 7 days and 50 weeks, diagnosed every 3 months with HIV-1 DNA PCR, in the modified intention-to-treat population (all who attended at least one follow-up visit). This trial is registered with ClinicalTrials.gov, number NCT00640263.
Between Nov 16, 2009, and May 7, 2012, we enrolled and randomised 1273 infants and analysed 1236; 615 assigned to lopinavir-ritonavir or 621 assigned to lamivudine. 17 HIV-1 infections were diagnosed in the study period (eight in the lopinavir-ritonavir group and nine in the lamivudine group), resulting in cumulative HIV-1 infection of 1·4% (95% CI 0·4-2·5) and 1·5% (0·7-2·5), respectively. Infection rates did not differ between the two drug regimens (hazard ratio [HR] of lopinavir-ritonavir versus lamivudine of 0·90, 95% CI 0·35-2·34; p=0·83). Clinical and biological severe adverse events did not differ between groups; 251 (51%) infants had a grade 3-4 event in the lopinavir-ritonavir group compared with 246 (50%) in the lamivudine group.
Infant HIV-1 prophylaxis with lopinavir-ritonavir was not superior to lamivudine and both drugs led to very low rates of HIV-1 postnatal transmission for up to 50 weeks of breastfeeding. Infant pre-exposure prophylaxis should be extended until the end of HIV-1 exposure and mothers should be informed about the persistent risk of transmission throughout breastfeeding.
INSERM/National Agency for Research on AIDS and Viral Hepatitis (including funds from the Total Foundation), European Developing Countries Clinical Trials Partnership, Research Council of Norway.
The Lancet 11/2015; DOI:10.1016/S0140-6736(15)00984-8 · 45.22 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: Background:
Good outcomes during pregnancy and childbirth are related to availability, utilisation and effective implementation of essential interventions for labour and childbirth. The majority of the estimated 289,000 maternal deaths, 2.8 million neonatal deaths and 2.6 million stillbirths every year could be prevented by improving access to and scaling up quality care during labour and birth.
The bottleneck analysis tool was applied in 12 countries in Africa and Asia as part of the Every Newborn Action Plan process. Country workshops engaged technical experts to complete the survey tool, which is designed to synthesise and grade health system "bottlenecks", factors that hinder the scale up, of maternal-newborn intervention packages. We used quantitative and qualitative methods to analyse the bottleneck data, combined with literature review, to present priority bottlenecks and actions relevant to different health system building blocks for skilled birth attendance and basic and comprehensive emergency obstetric care.
Across 12 countries the most critical bottlenecks identified by workshop participants for skilled birth attendance were health financing (10 out of 12 countries) and health workforce (9 out of 12 countries). Health service delivery bottlenecks were found to be the most critical for both basic and comprehensive emergency obstetric care (9 out of 12 countries); health financing was identified as having critical bottlenecks for comprehensive emergency obstetric care (9 out of 12 countries). Solutions to address health financing bottlenecks included strengthening national financing mechanisms and removing financial barriers to care seeking. For addressing health workforce bottlenecks, improved human resource planning is needed, including task shifting and improving training quality. For health service delivery, proposed solutions included improving quality of care and establishing public private partnerships.
Progress towards the 2030 targets for ending preventable maternal and newborn deaths is dependent on improving quality of care during birth and the immediate postnatal period. Strengthening national health systems to improve maternal and newborn health, as a cornerstone of universal health coverage, will only be possible by addressing specific health system bottlenecks during labour and birth, including those within health workforce, health financing and health service delivery.
[Show abstract][Hide abstract] ABSTRACT: Background:
Routine use of caesarean section for breech presentation is widespread. However poor outcomes after breech birth may be the result of underlying conditions causing breech presentation rather than damage during delivery.
The objective of this review was to assess the effects of planned caesarean section for breech presentation on measures of pregnancy outcome.
We searched the Cochrane Pregnancy and Childbirth trials register and the Cochrane Controlled Trials register. Date of last search: October 1997.
Randomised trials comparing planned caesarean section for breech presentation with planned vaginal delivery.
Data collection and analysis:
Reviewers assessed trial eligibility and quality.
Two studies involving 313 women were included. Caesarean section was done in 93% (119/128) of women allocated to planned caesarean section and 54% (99/185) of women in the planned vaginal delivery groups. The policy of planned caesarean section was associated with significantly increased maternal morbidity (relative risk 1.31, 95% confidence interval 1.02 to 1.68) and reduced short term neonatal morbidity (relative risk 0.26, 95% confidence interval 0.08 to 0.88). The studies were unable to detect differences in brachial plexus injuries, low Apgar scores or perinatal mortality.
There is not enough evidence to evaluate the use of a policy of planned caesarean section for breech presentation. A large Canadian trial addressing this question is currently underway.
[Show abstract][Hide abstract] ABSTRACT: Epidemiological findings suggest that the link between poverty and pre-eclampsia might be dietary calcium deficiency. Calcium supplementation has been associated with a modest reduction in pre-eclampsia, and also in blood pressure (BP).
[Show abstract][Hide abstract] ABSTRACT: Active management of the third stage of labour (AMTSL) consists of a group of interventions, including administration of a prophylactic uterotonic (at at or after delivery of the baby), baby, cord clamping and cutting, controlled cord traction (CCT) to deliver the placenta, and uterine massage. Recent recommendations are to delay cord clamping until the caregiver is ready to initiate CCT. The package of AMTSL reduces the risk of postpartum haemorrhage, (PPH), as does one component, routine use of uterotonics. The contribution, if any, of CCT needs to be quantified, as it is uncomfortable, and women may prefer a 'hands-off' approach. In addition its implementation has resource implications in terms of training of healthcare providers.
To evaluate the effects of controlled cord traction during the third stage of labour, either with or without conventional active management.
We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (29 January 2014), PubMed (1966 to 29 January 2014), and reference lists of retrieved studies.
Randomised controlled trials comparing planned CCT versus no planned CCT in women giving birth vaginally.
Two authors assessed trial quality and extracted data using a standard data extraction form.
We included three methodologically sound trials with data on 199, 4058 and 23,616 women respectively. Blinding was not possible, but bias could be limited by the fact that blood loss was measured objectively.There was no difference in the risk of blood loss ≥ 1000 mL (three trials, 27,454 women; risk ratio (RR) 0.91, 95% confidence interval (CI) 0.77 to 1.08). Manual removal of the placenta was reduced with CCT (two trials, 27,665 women; RR 0.69, 95% CI 0.57 to 0.83). In the World Health Organization (WHO) trial the reduction in manual removal occurred mainly in sites where ergometrine was used routinely in the third stage of labour. The non-prespecified analysis excluding sites routinely using ergometrine for management of the third stage of labour found no difference in the risk of manual removal of the placenta in the WHO trial (one trial, 23,010 women; RR 1.03, 95% CI 0.73 to 1.46). The policy of restricting the third stage of labour to 30 minutes (4057 women; RR 0.69, 95% CI 0.53 to 0.90) may have had an effect in the French study.Among the secondary outcomes, there were reductions in blood loss ≥ 500 mL (three trials, 27,454 women; RR 0.93, 95% CI 0.88 to 0.99), mean blood loss (two trials, 27,255 women; mean difference (MD) -10.85 mL, 95% CI -16.73 to -4.98), and duration of the third stage of labour (two trials, 27,360 women; standardised MD -0.57, -0.59 to -0.54). There were no clear differences in use of additional uterotonics (three trials, 27,829 women; average RR 0.95, 95% CI 0.88 to 1.02), blood transfusion, maternal death/severe morbidity, operative procedures nor maternal satisfaction. Maternal pain (non-prespecified) was reduced in one trial (3760 women; RR 0.78, 95% CI 0.61 to 0.99).The following secondary outcomes were not reported upon in any of the trials: retained placenta for more than 60 minutes or as defined by trial author; maternal haemoglobin less than 9 g/dL at 24 to 48 hours post-delivery or blood transfusion; organ failure; intensive care unit admission; caregiver satisfaction; cost-effectiveness; evacuation of retained products; or infection.
CCT has the advantage of reducing the risk of manual removal of the placenta in some circumstances, and evidence suggests that CCT can be routinely offered during the third stage of labour, provided the birth attendant has the necessary skills. CCT should remain a core competence of skilled birth attendants. However, the limited benefits of CCT in terms of severe PPH would not justify the major investment which would be needed to provide training in CCT skills for birth attendants who do not have formal training. Women who prefer a less interventional approach to management of the third stage of labour can be reassured that when a uterotonic agent is used, routine use of CCT can be omitted from the 'active management' package without increased risk of severe PPH, but that the risk of manual removal of the placenta may be increased.Research gaps include the use of CCT in the absence of a uterotonic, and the place of uterine massage in the management of the third stage of labour.
[Show abstract][Hide abstract] ABSTRACT: Several studies have suggested that prophylactic antibiotics given during pregnancy improved maternal and perinatal outcomes, while others have shown no benefit and some have reported adverse effects.
To determine the effect of prophylactic antibiotics on maternal and perinatal outcomes during the second and third trimester of pregnancy for all women or women at risk of preterm delivery.
We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (31 July 2014) and reference lists of retrieved articles.
Randomised controlled trials comparing prophylactic antibiotic treatment with placebo or no treatment for women in the second or third trimester of pregnancy before labour.
We assessed trial quality and extracted data.
The review included seven randomised controlled trials. Approximately 2100 women were recruited to detect the effect of prophylactic antibiotic administration on pregnancy outcomes. Primary outcomesAntibiotic prophylaxis did not reduce the risk of preterm prelabour rupture of membranes (risk ratio (RR) 0.31; 95% confidence interval (CI) 0.06 to 1.49 (one trial, 229 women) low quality evidence) or preterm delivery (RR 0.85; 95% CI 0.64 to 1.14 (five trials, 1480 women) low quality evidence). However, preterm delivery was reduced in the subgroup of pregnant women with a previous preterm birth who had bacterial vaginosis (BV) during the current pregnancy (RR 0.64; 95% CI 0.47 to 0.88 (one trial, 258 women), but there was no reduction in the subgroup of pregnant women with previous preterm birth without BV during the pregnancy (RR 1.08; 95% CI 0.66 to 1.77 (two trials, 500 women)). A reduction in the risk of postpartum endometritis (RR 0.55; 95% CI 0.33 to 0.92 (one trial, 196 women)) was observed in high-risk pregnant women (women with a history of preterm birth, low birthweight, stillbirth or early perinatal death) and in all women (RR 0.53; 95% CI 0.35 to 0.82 (three trials, 627 women) moderate quality evidence). There was no difference in low birth weight (RR 0.86; 95% CI 0.53 to 1.39 (four trials; 978 women) or neonatal sepsis (RR 11.31; 95% CI 0.64 to 200.79); and blood culture confirming sepsis was not reported in any of the studies. Secondary outcomesAntibiotic prophylaxis reduced the risk of prelabour rupture of membranes (RR 0.34; 95% CI 0.15 to 0.78 (one trial, 229 women) low quality evidence) and gonococcal infection (RR 0.35; 95% CI 0.13 to 0.94 (one trial, 204 women)). There were no differences observed in other secondary outcomes (congenital abnormality; small-for-gestational age; perinatal mortality), whilst many other secondary outcomes (e.g. intrapartum fever needing treatment with antibiotics) were not reported in included trials.Regarding the route of antibiotic administration, vaginal antibiotic prophylaxis during pregnancy did not prevent infectious pregnancy outcomes. The overall risk of bias was low except that incomplete outcome data produced high risk of bias in some studies. The quality of the evidence using GRADE was assessed as low for preterm prelabour rupture of membranes, low for preterm delivery, moderate for postpartum endometritis, low for prelabour rupture of membranes, and very low for chorioamnionitis. Intrapartum fever needing treatment with antibiotics was not reported in any of the included studies.
Antibiotic prophylaxis did not reduce the risk of preterm prelabour rupture of membranes or preterm delivery (apart from in the subgroup of women with a previous preterm birth who had bacterial vaginosis). Antibiotic prophylaxis given during the second or third trimester of pregnancy reduced the risk of postpartum endometritis, preterm rupture of membranes and gonococcal infection when given routinely to all pregnant women. Substantial bias possibly exists in the review's results because of a high rate of loss to follow-up and the small numbers of studies included in each of our analyses. There is also insufficient evidence on possible harmful effects on the baby. Therefore, we conclude that there is not enough evidence to recommend the use of routine antibiotics during pregnancy to prevent infectious adverse effects on pregnancy outcomes.
[Show abstract][Hide abstract] ABSTRACT: 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.ResultsAfter 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. However, they suggest that the OMBU model of birth care could help to reduce poor maternal and perinatal outcomes in South Africa. 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.
[Show abstract][Hide abstract] ABSTRACT: Caesarean section is a very common surgical procedure worldwide. Suturing the peritoneal layers at caesarean section may or may not confer benefit, hence the need to evaluate whether this step should be omitted or routinely performed.
[Show abstract][Hide abstract] ABSTRACT: Elective labor induction is an increasingly common practice not only in high-income countries, but also in many low-income and middle-income countries. Many questions remain unanswered on the safety and cost-effectiveness of elective labor induction, particularly in resource-constrained settings where there may be a high unmet need for medically indicated inductions, as well as limited or no access to appropriate medications and equipment for induction and monitoring, comprehensive emergency obstetric care, safe and timely cesarean section, and appropriate supervision from health professionals. This article considers the global perspective on the epidemiology, practices, safety, and costs associated with elective labor induction.
[Show abstract][Hide abstract] ABSTRACT: Concern about a possible association of hormonal contraception with HIV acquisition has been raised by three types of evidence. Firstly, high-dose progestogen treatment greatly increases HIV acquisition in female non-human primates. Secondly, biological plausibility for a link between hormonal contraception anf HIV acquisition is provided by evidence of a hypo-oestrogenic state induced by progestogen contraception with vaginal mucosal thinning, and evidence of effects on the humoral and cellular immune systems. Thirdly, some but not other large observational studies have found an increase in HIV acquisition among women using hormonal contraception.
[Show abstract][Hide abstract] ABSTRACT: Background Epidemiological data link low dietary calcium with pre-eclampsia. Current recommendations are for 1.5–2 g/day calcium supplementation for low-intake pregnant women, based on randomised controlled trials of ≥1 g/day calcium supplementation from 20 weeks of gestation. This is problematic logistically in low-resource settings; excessive calcium may be harmful; and 20 weeks may be too late to alter outcomes. Objectives
To review the impact of lower dose calcium supplementation on pre-eclampsia risk. Search strategy and selection criteriaWe searched PubMed and the Cochrane Pregnancy and Childbirth Group trials register. Data collection and analysisTwo authors extracted data from eligible randomised and quasi-randomised trials of low-dose calcium (LDC, <1 g/day), with or without other supplements. Main resultsPre-eclampsia was reduced consistently with LDC with or without co-supplements (nine trials, 2234 women, relative risk [RR] 0.38; 95% confidence interval [95% CI] 0.28–0.52), as well as for subgroups: LDC alone (four trials, 980 women, RR 0.36; 95% CI 0.23–0.57]); LDC plus linoleic acid (two trials, 134 women, RR 0.23; 95% CI 0.09–0.60); LDC plus vitamin D (two trials, 1060 women, RR 0.49; 0.31–0.78) and a trend for LDC plus antioxidants (one trial, 60 women, RR 0.24; 95% CI 0.06–1.01). Overall results were consistent with the single quality trial of LDC alone (171 women, RR 0.30; 95% CI 0.06–1.38). LDC plus antioxidants commencing at 8–12 weeks tended to reduce miscarriage (one trial, 60 women, RR 0.06; 95% CI 0.00–1.04). Conclusions
These limited data are consistent with LDC reducing the risk of pre-eclampsia; confirming this in sufficiently powered randomised controlled trials would have implications for current guidelines and their global implementation.
BJOG An International Journal of Obstetrics & Gynaecology 03/2014; 121(8). DOI:10.1111/1471-0528.12613 · 3.45 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: There is little doubt that women should be encouraged to utilise positions which give them the greatest comfort, control and benefit during first stage labour. As women in most western societies now lie in bed for the entire duration of their labour, it is important that they understand the risks and benefits of the positions they choose. This review included 25 studies (involving 5218 women). Although many studies were not of high quality, and most of the women were low risk, they did show that the first stage of labour may be approximately one hour and twenty minutes shorter for women who are upright or walk around. As every contraction is potentially painful, and prolonged labour can be an overwhelming and exhausting process resulting in an increased need for medical intervention, this is a meaningful outcome for women. Indeed other important outcomes for women who were upright and mobile compared with lying down in bed included a reduction in the risk of caesarean birth, less use of epidural as a method of pain relief, and less chance of their babies being admitted to the neonatal unit. More research of better quality is still needed to validate these results for all women in labour. However, based on the results of this review we recommend that wherever possible, women should be encouraged and supported to use upright and mobile positions of their choice during first stage labour, as this may enhance the progress of their labour and may lead to better outcomes for themselves and their babies.