Suellen Miller

On the continuum of maternal health care, two extreme situations exist: too little, too late (TLTL) and too much, too soon (TMTS). TLTL describes care with inadequate resources, below evidence-based standards, or care withheld or unavailable until too late to help. TLTL is an underlying problem associated with high maternal mortality and morbidity. TMTS describes the routine over-medicalisation of normal pregnancy and birth. TMTS includes unnecessary use of non-evidence-based interventions, as well as use of interventions that can be life saving when used appropriately, but harmful when applied routinely or overused. As facility births increase, so does the recognition that TMTS causes harm and increases health costs, and often concentrates disrespect and abuse. Although TMTS is typically ascribed to high-income countries and TLTL to low-income and middle-income ones, social and health inequities mean these extremes coexist in many countries. A global approach to quality and equitable maternal health, supporting the implementation of respectful, evidence-based care for all, is urgently needed. We present a systematic review of evidence-based clinical practice guidelines for routine antenatal, intrapartum, and postnatal care, categorising them as recommended, recommended only for clinical indications, and not recommended. We also present prevalence data from middle-income countries for specific clinical practices, which demonstrate TLTL and increasing TMTS. Health-care providers and health systems need to ensure that all women receive high-quality, evidence-based, equitable and respectful care. The right amount of care needs to be offered at the right time, and delivered in a manner that respects, protects, and promotes human rights.

The informed consent process is an essential com-ponent of ethical clinical research.' Despite the growing emphasis on the use of simple, nontech-nical language and clear explanations,2 researchers and ethicists are concerned that many individuals, even in ...

Objective: To use a comparative cost-effectiveness approach with evidence from four countries to understand which facility level is most appropriate for implementing the non-pneumatic anti-shock garment (NASG) to decrease maternal mortality associated with obstetric hemorrhage (OH). Methods: Two data sources were compared. We determined the cost-effectiveness of NASG application for women with hypovolemic shock from OH at the referral hospitals (RH) compared to standard of care within a two-phase intervention study of 6 RH in Egypt and Nigeria. To specify the cost-effectiveness of applying the NASG at the primary health clinic (PHC) level compared to the RH, we estimated random-effects models within a cluster-randomized control trial of 38 primary health clinics (PHC) in Zambia and Zimbabwe. Costs (blood transfusions, medications, etc.) and disability-adjusted life years (DALYs) were compared across the intervention scenarios. Results: The NASG was cost saving ($77-85 per woman in E...

To discuss the role of nurses and nurse-midwives in preventing and treating postpartum hemorrhage (PPH) from uterine atony in developing countries and examine the role of a new device, the non-pneumatic anti-shock garment (NASG), in improving the outcomes for these patients. In this subanalysis of a larger preintervention phase/intervention phase study of 1,442 women with obstetric hemorrhage, postpartum women with hypovolemic shock (N = 578) from uterine atony (≥750 mL blood loss; systolic blood pressure <100 mmHg and/or pulse >100 beats per minute) were enrolled in two referral facilities in Egypt and four referral facilities in Nigeria. The study had two temporal phases: a preintervention phase and an NASG-intervention phase. Women with hemorrhage and shock in both phases were treated with the same evidence-based protocols for management of hypovolemic shock and hemorrhage, but women in the NASG-intervention phase also received the NASG. Relative risks (RRs) with 95% confid...

Objective: To assess the cost-effectiveness of non-pneumatic anti-shock garments (NASG) for obstetric hemorrhage in tertiary hospitals in Egypt and Nigeria. Methods: Results from published pre-intervention/NASG-intervention phase trials for women in severe shock (mean arterial pressure (MAP)<60) were standardized for 1,000 women. Clinical data included frequencies of health outcomes (mortality, major morbidity, severe anemia), and interventions to control bleeding (uterotonics, blood transfusions, hysterectomies). Costs (2010 international dollars) included the NASG, training, and clinical interventions. Changes in cost, morbidity, mortality, and disability-adjusted life years (DALYs) were used to calculate incremental cost-effectiveness ratios (ICERs; cost per DALY averted) for each country and study phase. We examined hysterectomies for all etiologies and for intractable uterine atony only. Results: Women with severe shock who received the NASG had lower mortality and morbidity...

Obstetric fistula is a debilitating birth injury that affects an estimated 2-3 million women globally, most in sub-Saharan Africa and Asia. The urinary and/or fecal incontinence associated with fistula affects women physically, psychologically and socioeconomically. Surgical management of fistula is available with clinical success rates ranging from 65-95 %. Previous research on fistula repair outcomes has focused primarily on clinical outcomes without considering the broader goal of successful reintegration into family and community. The objectives for this study are to understand the process of family and community reintegration post fistula surgery and develop a measurement tool to assess long-term success of post-surgical family and community reintegration. This study is an exploratory sequential mixed-methods design including a preliminary qualitative component comprising in-depth interviews and focus group discussions to explore reintegration to family and community after fistula surgery. These results will be used to develop a reintegration tool, and the tool will be validated within a small longitudinal cohort (n = 60) that will follow women for 12 months after obstetric fistula surgery. Medical record abstraction will be conducted for patients managed within the fistula unit. Ethical approval for the study has been granted. This study will provide information regarding the success of family and community reintegration among women returning home after obstetric fistula surgery. The clinical and research community can utilize the standardized measurement tool in future studies of this patient population.

Objective: To examine whether women with hypovolemic shock secondary to obstetric hemorrhage are transported to referral hospitals differently depending on weeks of pregnancy in Zambia. Methods: In a retrospective study, transport type, wait time, and transit time were assessed for women with obstetric hemorrhage and hypovolemic shock transported from 26 primary health centers to three referral hospitals during 2007-2012. A mean arterial pressure of less than 60 mm Hg was used to indicate severe shock. Women were split into two categories on the basis of the number of weeks of pregnancy (<24 weeks vs 24 weeks). Results: Overall, 616 women were included. Mode of transport differed significantly by group (P < 0.001). 414 (93.0%) of 445 women at 24 weeks of pregnancy or more were transported by ambulance versus 114 (66.7%) of 171 women at less than 24 weeks. Among those in severe shock, 106 (93.0%) of 114 women at 24 weeks of pregnancy or more were transported in ambulances versu...

To determine the optimal vital sign predictor of adverse maternal outcomes in women with hypovolemic shock secondary to obstetric hemorrhage and to develop thresholds for referral/intensive monitoring and need for urgent intervention to inform a vital sign alert device for low-resource settings. We conducted secondary analyses of a dataset of pregnant/postpartum women with hypovolemic shock in low-resource settings (n = 958). Using receiver-operating curve analysis, we evaluated the predictive ability of pulse, systolic blood pressure, diastolic blood pressure, shock index, mean arterial pressure, and pulse pressure for three adverse maternal outcomes: (1) death, (2) severe maternal outcome (death or severe end organ dysfunction morbidity); and (3) a combined severe maternal and critical interventions outcome comprising death, severe end organ dysfunction morbidity, intensive care admission, blood transfusion ≥ 5 units, or emergency hysterectomy. Two threshold parameters with optimal rule-in and rule-out characteristics were selected based on sensitivities, specificities, and positive and negative predictive values. Shock index was consistently among the top two predictors across adverse maternal outcomes. Its discriminatory ability was significantly better than pulse and pulse pressure for maternal death (p<0.05 and p<0.01, respectively), diastolic blood pressure and pulse pressure for severe maternal outcome (p<0.01), and systolic and diastolic blood pressure, mean arterial pressure and pulse pressure for severe maternal outcome and critical interventions (p<0.01). A shock index threshold of ≥ 0.9 maintained high sensitivity (100.0) with clinical practicality, ≥ 1.4 balanced specificity (range 70.0-74.8) with negative predictive value (range 93.2-99.2), and ≥ 1.7 further improved specificity (range 80.7-90.8) without compromising negative predictive value (range 88.8-98.5). For women with hypovolemic shock from obstetric hemorrhage, shock index was consistently a strong predictor of all adverse outcomes. In lower-level facilities in low resource settings, we recommend a shock index threshold of ≥ 0.9 indicating need for referral, ≥ 1.4 indicating urgent need for intervention in tertiary facilities and ≥ 1.7 indicating high chance of adverse outcome. The vital sign alert device incorporated values 0.9 and 1.7; however, all thresholds will be prospectively validated and clinical pathways for action appropriate to setting established prior to clinical implementation.