A primary health care model for managing pre-eclampsia and eclampsia in low- and middle- income countries.

BACKGROUND: Hypertensive disorders in pregnancy, specifically pre-eclampsia and eclampsia (PE/E), are the second biggest killer of pregnant women globally and remains the least understood and most challenging maternal morbidity to manage. Although great strides were made in reducing maternal and newborn mortality between 1990 and 2015, this was clearly not enough to achieve the global health goals. To reduce maternal deaths: 1) early detection of PE needs to be improved; 2) effective management of PE/E needs to occur at lower health system levels and should encourage timely care-seeking; and 3) prioritizing the scale up of a comprehensive package of services near to where women live. FINDINGS: This commentary describes a pragmatic approach to test scalable and sustainable strategies for expanding access to quality under-utilized maternal health commodities, interventions and services. We present a primary health care (PHC) PE/E Model based on implementation research on identified gaps in care in several countries, accepted global best practice and built on the basic premise that PHC providers can take on additional skills with adequate capacity building, coaching and supervision, and community members desire control over their own health. The PHC PE/E model displays the linkages and opportunities to prevent and treat PE/E in a simplified way; however, there are numerous interlinking factors, angles, and critical points to consider including leadership, policies and protocols; relevant medicines and commodities, ongoing capacity building strategies at lower levels and understanding what women and their communities want for safe pregnancies. CONCLUSION: The PHC model described here uses PE/E as an entry to improve the quality of ANC and by extension the pregnancy continuum. Bringing preventive and treatment services nearer to where pregnant women live makes sense.

Postpartum hemorrhage care bundles to improve adherence to guidelines: A WHO technical consultation.

OBJECTIVE: To systematically develop evidence-based bundles for care of postpartum hemorrhage (PPH). METHODS: An international technical consultation was conducted in 2017 to develop draft bundles of clinical interventions for PPH taken from the WHO's 2012 and 2017 PPH recommendations and based on the validated "GRADE Evidence-to-Decision" framework. Twenty-three global maternal-health experts participated in the development process, which was informed by a systematic literature search on bundle definitions, designs, and implementation experiences. Over a 6-month period, the expert panel met online and via teleconferences, culminating in a 2-day in-person meeting. RESULTS: The consultation led to the definition of two care bundles for facility implementation. The "first response to PPH bundle" comprises uterotonics, isotonic crystalloids, tranexamic acid, and uterine massage. The "response to refractory PPH bundle" comprises compressive measures (aortic or bimanual uterine compression), the non-pneumatic antishock garment, and intrauterine balloon tamponade (IBT). Advocacy, training, teamwork, communication, and use of best clinical practices were defined as PPH bundle supporting elements. CONCLUSION: For the first response bundle, further research should assess its feasibility, acceptability, and effectiveness; and identify optimal implementation strategies. For the response to refractory bundle, further research should address pending controversies, including the operational definition of refractory PPH and effectiveness of IBT devices.

Obstetric ultrasound use in low and middle income countries: a narrative review.

INTRODUCTION: Although growing, evidence on the impact, access, utility, effectiveness, and cost-benefit of obstetric ultrasound in resource-constrained settings is still somewhat limited. Hence, questions around the purpose and the intended benefit as well as potential challenges across various domains must be carefully reviewed prior to implementation and scale-up of obstetric ultrasound technology in low-and middle-income countries (LMICs). MAIN BODY: This narrative review discusses these issues for those trying to implement or scale-up ultrasound technology in LMICs. Issues addressed in this review include health personnel capacity, maintenance, cost, overuse and misuse of ultrasound, miscommunication between the providers and patients, patient diagnosis and care management, health outcomes, patient perceptions and concerns about fetal sex determination. CONCLUSION: As cost of obstetric ultrasound becomes more affordable in LMICs, it is essential to assess the benefits, trade-offs and potential drawbacks of large-scale implementation. Additionally, there is a need to more clearly identify the capabilities and the limitations of ultrasound, particularly within the context of limited training of providers, to ensure that the purpose for which an ultrasound is intended is actually feasible. We found evidence of obstetric uses of ultrasound improving patient management. However, there was evidence that ultrasound use is not associated with reducing maternal, perinatal or neonatal mortality. Patients in various studies reported to have both positive and negative perceptions and experiences related to ultrasound and lastly, illegal use of ultrasound for determining fetal sex was raised as a concern.

Are national policies and programs for prevention and management of postpartum hemorrhage and preeclampsia adequate? A key informant survey in 37 countries.

INTRODUCTION: Although maternal mortality has declined substantially in recent years, efforts to address postpartum hemorrhage (PPH) and preeclampsia/eclampsia (PE/E) must be systematically scaled up in order for further reduction to take place. In 2012, a key informant survey was conducted to identify both national and global gaps in PPH and PE/E program priorities and to highlight focus areas for future national and global programming. METHODS: Between January and March 2012, national program teams in 37 countries completed a 44-item survey, consisting mostly of dichotomous yes/no responses and addressing 6 core programmatic areas: policy, training, medication distribution and logistics, national reporting of key indicators, programming, and challenges to and opportunities for scale up. An in-country focal person led the process to gather the necessary information from key local stakeholders. Some countries also provided national essential medicines lists and service delivery guidelines for comparison and further analysis. RESULTS: Most surveyed countries have many elements in place to address PPH and PE/E, but notable gaps remain in both policy and practice. Oxytocin and magnesium sulfate were reported to be regularly available in facilities in 89% and 76% of countries, respectively. Only 27% of countries, however, noted regular availability of misoprostol in health facilities. Midwife scope of practice regarding PPH and PE/E is inconsistent with global norms in a number of countries: 22% of countries do not allow midwives to administer magnesium sulfate and 30% do not allow them to perform manual removal of the placenta. CONCLUSIONS: Most countries surveyed have many of the essential policies and program elements to prevent/manage PPH and PE/E, but absence of commodities (especially misoprostol), limitations in scope of practice for midwives, and gaps in inclusion of maternal health indicators in the national data systems have impeded efforts to scale up programs nationally.

Effect on postpartum hemorrhage of prophylactic oxytocin (10 IU) by injection by community health officers in Ghana: a community-based, cluster-randomized trial.

BACKGROUND: Oxytocin (10 IU) is the drug of choice for prevention of postpartum hemorrhage (PPH). Its use has generally been restricted to medically trained staff in health facilities. We assessed the effectiveness, safety, and feasibility of PPH prevention using oxytocin injected by peripheral health care providers without midwifery skills at home births. METHODS AND FINDINGS: This community-based, cluster-randomized trial was conducted in four rural districts in Ghana. We randomly allocated 54 community health officers (stratified on district and catchment area distance to a health facility: ≥10 km versus <10 km) to intervention (one injection of oxytocin [10 IU] one minute after birth) and control (no provision of prophylactic oxytocin) arms. Births attended by a community health officer constituted a cluster. Our primary outcome was PPH, using multiple definitions; (PPH-1) blood loss ≥500 mL; (PPH-2) PPH-1 plus women who received early treatment for PPH; and (PPH-3) PPH-2 plus any other women referred to hospital for postpartum bleeding. Unsafe practice is defined as oxytocin use before delivery of the baby. We enrolled 689 and 897 women, respectively, into oxytocin and control arms of the trial from April 2011 to November 2012. In oxytocin and control arms, respectively, PPH-1 rates were 2.6% versus 5.5% (RR: 0.49; 95% CI: 0.27-0.88); PPH-2 rates were 3.8% versus 10.8% (RR: 0.35; 95% CI: 0.18-0.63), and PPH-3 rates were similar to those of PPH-2. Compared to women in control clusters, those in the intervention clusters lost 45.1 mL (17.7-72.6) less blood. There were no cases of oxytocin use before delivery of the baby and no major adverse events requiring notification of the institutional review boards. Limitations include an unblinded trial and imbalanced numbers of participants, favoring controls. CONCLUSION: Maternal health care planners can consider adapting this model to extend the use of oxytocin into peripheral settings including, in some contexts, home births. TRIAL REGISTRATION: ClinicalTrials.gov NCT01108289 Please see later in the article for the Editors' Summary.

Impact on postpartum hemorrhage of prophylactic administration of oxytocin 10 IU via Uniject™ by peripheral health care providers at home births: design of a community-based cluster-randomized trial.

BACKGROUND: Hemorrhage is the leading direct cause of maternal death globally. While oxytocin is the drug of choice for postpartum hemorrhage prevention, its use has generally been limited to health facilities. This trial assesses the effectiveness, safety, and feasibility of expanding the use of prophylactic intramuscular oxytocin to peripheral health care providers at home births in four predominantly rural districts in central Ghana. METHODS: This study is designed as a community-based cluster-randomized trial in which Community Health Officers are randomized to provide (or not provide) an injection of oxytocin 10 IU via the Uniject™ injection system within one minute of delivery of the baby to women who request their presence at home at the onset of labor. The primary aim is to determine if administration of prophylactic oxytocin via Uniject™ by this cadre will reduce the risk of postpartum hemorrhage by 50 % relative to deliveries which do not receive the prophylactic intervention. Postpartum hemorrhage is examined under three sequential definitions: 1) blood loss ≥500 ml (BL); 2) treatment for bleeding (TX) and/or BL; 3) hospital referral for bleeding and/or TX and/or BL. Secondary outcomes address safety and feasibility of the intervention and include adverse maternal and fetal outcomes and logistical concerns regarding assistance at home births and the storage and handling of oxytocin, respectively. DISCUSSION: Results from this trial will build evidence for the effectiveness of expanding the delivery of this established prophylactic intervention to peripheral settings. Complementary data on safety and logistical issues related to this intervention will assist policymakers in low-income countries in selecting both the best uterotonic and service delivery strategy for postpartum hemorrhage prevention. Results of this trial are expected in mid-2013. The trial is registered at ClinicalTrials.gov: NCT01108289.

Active management of the third stage of labour with and without controlled cord traction: a randomised, controlled, non-inferiority trial.

BACKGROUND: Active management of the third stage of labour reduces the risk of post-partum haemorrhage. We aimed to assess whether controlled cord traction can be omitted from active management of this stage without increasing the risk of severe haemorrhage. METHODS: We did a multicentre, non-inferiority, randomised controlled trial in 16 hospitals and two primary health-care centres in Argentina, Egypt, India, Kenya, the Philippines, South Africa, Thailand, and Uganda. Women expecting to deliver singleton babies vaginally (ie, not planned caesarean section) were randomly assigned (in a 1:1 ratio) with a centrally generated allocation sequence, stratified by country, to placental delivery with gravity and maternal effort (simplified package) or controlled cord traction applied immediately after uterine contraction and cord clamping (full package). After randomisation, allocation could not be concealed from investigators, participants, or assessors. Oxytocin 10 IU was administered immediately after birth with cord clamping after 1-3 min. Uterine massage was done after placental delivery according to local policy. The primary (non-inferiority) outcome was blood loss of 1000 mL or more (severe haemorrhage). The non-inferiority margin for the risk ratio was 1·3. Analysis was by modified intention-to-treat, excluding women who had emergency caesarean sections. This trial is registered with the Australian and New Zealand Clinical Trials Registry, ACTRN 12608000434392. FINDINGS: Between June 1, 2009, and Oct 30, 2010, 12,227 women were randomly assigned to the simplified package group and 12,163 to the full package group. After exclusion of women who had emergency caesarean sections, 11,861 were in the simplified package group and 11,820 were in the full package group. The primary outcome of blood loss of 1000 mL or more had a risk ratio of 1·09 (95% CI 0·91-1·31) and the upper 95% CI limit crossed the pre-stated non-inferiority margin. One case of uterine inversion occurred in the full package group. Other adverse events were haemorrhage-related. INTERPRETATION: Although the hypothesis of non-inferiority was not met, omission of controlled cord traction has very little effect on the risk of severe haemorrhage. Scaling up of haemorrhage prevention programmes for non-hospital settings can safely focus on use of oxytocin. FUNDING: United States Agency for International Development and UN Development Programme/UN Population Fund/WHO/World Bank Special Programme of Research, Development and Research Training in Human Reproduction, Department of Reproductive Health and Research.

Using Uniject to increase the use of prophylactic oxytocin for management of the third stage of labor in Latin America.

OBJECTIVE: To evaluate a multifaceted intervention for effectiveness in increasing the use of prophylactic oxytocin by birth attendants (obstetricians, midwives, and nurses) working in small maternity hospitals in Argentina. METHODS: A before-and-after quasi-experimental study was conducted in 5 small maternity hospitals. The study intervention consisted of training birth attendants in the active management of the third stage of labor, distributing oxytocin in Uniject (Hipofisina BIOL Uniject; Laboratorios BIOL, Buenos Aires, Argentina), and using posters as reminders. The primary outcome was the rate of prophylactic oxytocin use in the 6 months before and the 6 months of the intervention period. Secondary outcomes included use of controlled cord traction and uterine massage, and birth attendants' acceptance of the use of oxytocin in Uniject. RESULTS: The use of prophylactic oxytocin showed a median rate of 14.6% at baseline and 85.6% during the intervention period. 96% of birth attendants reported that the Uniject device facilitated oxytocin 1 administration. DISCUSSION: Prophylactic oxytocin in the third stage of labor is a beneficial intervention with current low use, particularly in low- and middle-income countries. If the results shown in the present study were further replicated, this strategy could be an effective method for improving prophylactic oxytocin use in other similar Latin American hospitals.

Uterotonic use at home births in low-income countries: a literature review.

OBJECTIVES: This literature review compiles data on rates of use, indications, types of provider, mode of administration, and dose of uterotonics used for home births in low-income countries, and identifies gaps meriting further research. METHODS: Published and unpublished English language articles from 1995 through 2008 pertaining to home use of uterotonics were identified via electronic searches of medical and social science databases. In addition, bibliographies of articles were examined for eligible studies. Data were abstracted and analyzed by the objectives outlined for this review. RESULTS: Twenty-three articles met the inclusion/exclusion criteria. Use rates of uterotonics at home births ranged widely from 1% to 69%, with the large majority of observations from South Asia. Descriptive studies suggest that home use of uterotonics before delivery of the baby are predominantly administered by nonprofessionals to accelerate labor, and are not perceived as unsafe. CONCLUSIONS: To achieve maximum benefit and minimal harm, programs that increase access to uterotonics for postpartum hemorrhage prevention must take into account existing practices among pregnant women. Further research regarding access to uterotonics and intervention studies for provider behavior change regarding uterotonic use is warranted.

Health facility-based Active Management of the Third Stage of Labor: findings from a national survey in Tanzania.

BACKGROUND: Hemorrhage is the leading cause of obstetric mortality. Studies show that Active Management of Third Stage of Labor (AMTSL) reduces Post Partum Hemorrhage (PPH). This study describes the practice of AMTSL and barriers to its effective use in Tanzania. METHODS: A nationally-representative sample of 251 facility-based vaginal deliveries was observed for the AMTSL practice. Standard Treatment Guidelines (STG), the Essential Drug List and medical and midwifery school curricula were reviewed. Drug availability and storage conditions were reviewed at the central pharmaceutical storage site and pharmacies in the selected facilities. Interviews were conducted with hospital directors, pharmacists and 106 health care providers in 29 hospitals visited. Data were collected between November 10 and December 15, 2005. RESULTS: Correct practice of AMTSL according to the ICM/FIGO definition was observed in 7% of 251 deliveries. When the definition of AMTSL was relaxed to allow administration of the uterotonic drug within three minutes of fetus delivery, the proportion of AMTSL use increased to 17%. The most significant factor contributing to the low rate of AMTSL use was provision of the uterotonic drug after delivery of the placenta. The study also observed potentially-harmful practices in approximately 1/3 of deliveries. Only 9% out of 106 health care providers made correct statements regarding the all three components of AMTSL. The national formulary recommends ergometrine (0.5 mg/IM) or oxytocin (5 IU/IM) on delivery of the anterior shoulder or immediately after the baby is delivered. Most of facilities had satisfactory stores of drugs and supplies. Uterotonic drugs were stored at room temperature in 28% of the facilities. CONCLUSION: The knowledge and practice of AMTSL is very low and STGs are not updated on correct AMTSL practice. The drugs for AMTSL are available and stored at the right conditions in nearly all facilities. All providers used ergometrine for AMTSL instead of oxytocin as recommended by ICM/FIGO. The study also observed harmful practices during delivery. These findings indicate that there is a need for updating the STGs, curricula and training of health providers on AMTSL and monitoring its practice.

Use of active management of the third stage of labour in seven developing countries.

OBJECTIVE: To document the use of active management of the third stage of labour for preventing postpartum haemorrhage and to explore factors associated with such use in seven developing countries. METHODS: Nationally representative samples of facility-based deliveries were selected and observed to determine the use of active management of the third stage of labour and associated factors. Policies on active management were assessed through document review and interviews with relevant professionals. FINDINGS: Use of a uterotonic during the third or fourth stages of labour was nearly universal. Correct use of active management of the third stage of labour was found in only 0.5% to 32% of observed deliveries due to multiple deficiencies in practice. In every country except Indonesia, policies regarding active management were conflicting. CONCLUSION: Developing countries have not targeted decreasing postpartum haemorrhage as an achievable goal; there is little use of active management of the third stage of labour, and policies regarding such management often conflict. Studies are needed to identify the most effective components of active management so that the most efficient package of practices can be promoted.

Active management of the third stage of labour without controlled cord traction: a randomized non-inferiority controlled trial.

BACKGROUND: The third stage of labour refers to the period between birth of the baby and complete expulsion of the placenta. Some degree of blood loss occurs after the birth of the baby due to separation of the placenta. This period is a risky period because uterus may not contract well after birth and heavy blood loss can endanger the life of the mother. Active management of the third stage of labour (AMTSL) reduces the occurrence of severe postpartum haemorrhage by approximately 60-70%. Active management consists of several interventions packaged together and the relative contribution of each of the components is unknown. Controlled cord traction is one of those components that require training in manual skill for it to be performed appropriately. If it is possible to dispense with controlled cord traction without losing efficacy it would have major implications for effective management of the third stage of labour at peripheral levels of health care. OBJECTIVE: The primary objective is to determine whether the simplified package of oxytocin 10 IU IM/IV is not less effective than the full AMTSL package. METHODS: A hospital-based, multicentre, individually randomized controlled trial is proposed. The hypothesis tested will be a non-inferiority hypothesis. The aim will be to determine whether the simplified package without CCT, with the advantage of not requiring training to acquire the manual skill to perform this task, is not less effective than the full AMTSL package with regard to reducing blood loss in the third stage of labour.The simplified package will include uterotonic (oxytocin 10 IU IM) injection after delivery of the baby and cord clamping and cutting at approximately 3 minutes after birth. The full package will include the uterotonic injection (oxytocin 10 IU IM), controlled cord traction following observation of uterine contraction and cord clamping and cutting at approximately 3 minutes after birth. The primary outcome measure is blood loss of 1000 ml or more at one hour and up to two hours for women who continue to bleed after one hour. The secondary outcomes are blood transfusion, the use of additional uterotonics and measure of severe morbidity and maternal death.We aim to recruit 25,000 women delivering vaginally in health facilities in eight countries within a 12 month recruitment period. MANAGEMENT: Overall trial management will be from HRP/RHR in Geneva. There will be eight centres located in Argentina, Egypt, India, Kenya, Philippines, South Africa, Thailand and Uganda. There will be an online data entry system managed from HRP/RHR. The trial protocol was developed following a technical consultation with international organizations and leading researchers in the field. EXPECTED OUTCOMES: The main objective of this trial is to investigate whether a simplified package of third stage management can be recommended without increasing the risk of PPH. By avoiding the need for a manual procedure that requires training, the third stage management can be implemented in a more widespread and cost-effective way around the world even at the most peripheral levels of the health care system. This trial forms part of the programme of work to reduce maternal deaths due to postpartum haemorrhage within the RHR department in collaboration with other research groups and organizations active in the field. TRIAL REGISTRATION: ACTRN12608000434392.

How to avoid iatrogenic morbidity and mortality while increasing availability of oxytocin and misoprostol for PPH prevention?

OBJECTIVE: Increased availability of oxytocin and misoprostol is needed to reduce the risk of postpartum hemorrhage. This review compiles rates and risks of adverse maternal and perinatal outcomes associated with use of these medications for labor induction and augmentation in low-income countries. Recommendations are proposed based on the findings. METHODS: We did a structured literature review using 5 databases followed by analysis of induction and augmentation rates from existing data. RESULTS: Combined induction and augmentation rates were documented in up to 50% of hospital-based deliveries identified in the databases. Data are sparse but suggest associations between induction/augmentation and stillbirth, neonatal resuscitation, and uterine rupture, and inappropriate administration of oxytocin and misoprostol both outside and inside healthcare systems in low-income countries. CONCLUSIONS: Guidelines for labor induction/augmentation are needed specifically for low resourced settings. Rigorous studies should be pursued to quantify the magnitude and effect of inappropriate induction and augmentation on maternal and perinatal morbidity and mortality. Programs are needed to ensure community-wide awareness of the adverse effects of the improper use of these drugs on mothers and babies, especially in out-of-hospital settings.

The use of chlorhexidine to reduce maternal and neonatal mortality and morbidity in low-resource settings.

Of the 4 million neonatal deaths and 500,000 maternal deaths that occur annually worldwide, almost 99% are in developing countries and one-third are associated with infections. Implementation of proven interventions and targeted research on a select number of promising high-impact preventative and curative interventions are essential to achieve Millennium Development Goals for reduction of child and maternal mortality. Feasible, simple, low-cost interventions have the potential to significantly reduce the mortality and severe morbidity associated with infection in these settings. Studies of chlorhexidine in developing countries have focused on three primary uses: 1) intrapartum vaginal and neonatal wiping, 2) neonatal wiping alone, and 3) umbilical cord cleansing. A study of vaginal wiping and neonatal skin cleansing with chlorhexidine, conducted in Malawi in the 1990s suggested that chlorhexidine has potential to reduce neonatal infectious morbidity and mortality. A recent trial of cord cleansing conducted in Nepal also demonstrated benefit. Although studies have shown promise, widespread acceptance and implementation of chlorhexidine use has not yet occurred. This paper is derived in part from data presented at a conference on the use of chlorhexidine in developing countries and reviews the available evidence related to chlorhexidine use to reduce mortality and severe morbidity due to infections in mothers and neonates in low-resource settings. It also summarizes issues related to programmatic implementation.