Community-based screening for obstetric fistula in Nigeria: a novel approach.

BACKGROUND: Obstetric fistula continues to have devastating effects on the physical, social, and economic lives of thousands of women in many low-resource settings. Governments require credible estimates of the backlog of existing cases requiring care to effectively plan for the treatment of fistula cases. Our study aims to quantify the backlog of obstetric fistula cases within two states via community-based screenings and to assess the questions in the Demographic Health Survey (DHS) fistula module. METHODS: The screening sites, all lower level health facilities, were selected based on their geographic coverage, prior relationships with the communities and availability of fistula surgery facilities in the state. This cross-sectional study included women who presented for fistula screenings at study facilities based on their perceived fistula-like symptoms. Research assistants administered the pre-screening questionnaire. Nurse-midwives then conducted a medical exam. Univariate and bivariate analyses are presented. RESULTS: A total of 268 women attended the screenings. Based on the pre-screening interview, the backlog of fistula cases reported was 75 (28% of women screened). The backlog identified after the medical exam was 26 fistula cases (29.5% of women screened) in Kebbi State sites and 12 cases in Cross River State sites (6.7%). Verification assessment showed that the DHS questionnaire had 92% sensitivity, 83% specificity with 47% positive predictive value and 98% negative predictive value for identifying women afflicted by fistula among women who came for the screenings. CONCLUSIONS: This methodology, involving effective, locally appropriate messaging and community outreach followed up with medical examination by nurse-midwives at lower level facilities, is challenging, but represents a promising approach to identify the backlog of women needing surgery and to link them with surgical facilities.

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.

Validation studies for population-based intervention coverage indicators: design, analysis, and interpretation.

BACKGROUND: Population-based intervention coverage indicators are widely used to track country and program progress in improving health and to evaluate health programs. Indicator validation studies that compare survey responses to a "gold standard" measure are useful to understand whether the indicator provides accurate information. The Improving Coverage Measurement (ICM) Core Group has developed and implemented a standard approach to validating coverage indicators measured in household surveys, described in this paper. METHODS: The general design of these studies includes measurement of true health status and intervention receipt (gold standard), followed by interviews with the individuals observed, and a comparison of the observations (gold standard) to the responses to survey questions. The gold standard should use a data source external to the respondent to document need for and receipt of an intervention. Most frequently, this is accomplished through direct observation of clinical care, and/or use of a study-trained clinician to obtain a gold standard diagnosis. Follow-up interviews with respondents should employ standard survey questions, where they exist, as well as alternative or additional questions that can be compared against the standard household survey questions. RESULTS: Indicator validation studies should report on participation at every stage, and provide data on reasons for non-participation. Metrics of individual validity (sensitivity, specificity, area under the receiver operating characteristic curve) and population-level validity (inflation factor) should be reported, as well as the percent of survey responses that are "don't know" or missing. Associations between interviewer and participant characteristics and measures of validity should be assessed and reported. CONCLUSIONS: These methods allow respondent-reported coverage measures to be validated against more objective measures of need for and receipt of an intervention, and should be considered together with cognitive interviewing, discriminative validity, or reliability testing to inform decisions about which indicators to include in household surveys. Public health researchers should assess the evidence for validity of existing and proposed household survey coverage indicators and consider validation studies to fill evidence gaps.

Improving coverage measurement for reproductive, maternal, neonatal and child health: gaps and opportunities.

BACKGROUND: Regular monitoring of coverage for reproductive, maternal, neonatal, and child health (RMNCH) is central to assessing progress toward health goals. The objectives of this review were to describe the current state of coverage measurement for RMNCH, assess the extent to which current approaches to coverage measurement cover the spectrum of RMNCH interventions, and prioritize interventions for a novel approach to coverage measurement linking household surveys with provider assessments. METHODS: We included 58 interventions along the RMNCH continuum of care for which there is evidence of effectiveness against cause-specific mortality and stillbirth. We reviewed household surveys and provider assessments used in low- and middle-income countries (LMICs) to determine whether these tools generate measures of intervention coverage, readiness, or quality. For facility-based interventions, we assessed the feasibility of linking provider assessments to household surveys to provide estimates of intervention coverage. RESULTS: Fewer than half (24 of 58) of included RMNCH interventions are measured in standard household surveys. The periconceptional, antenatal, and intrapartum periods were poorly represented. All but one of the interventions not measured in household surveys are facility-based, and 13 of these would be highly feasible to measure by linking provider assessments to household surveys. CONCLUSIONS: We found important gaps in coverage measurement for proven RMNCH interventions, particularly around the time of birth. Based on our findings, we propose three sets of actions to improve coverage measurement for RMNCH, focused on validation of coverage measures and development of new measurement approaches feasible for use at scale in LMICs.

Methodological issues in the measurement of birth preparedness in support of safe motherhood.

Behavior change interventions focusing on birth preparedness for pregnant women, their husbands, and adults in the community are common components of community-oriented Safe Motherhood programs in developing countries. Few studies have examined the effectiveness of these interventions, and existing studies are flawed due to study and sample design. This article highlights methodological issues that are often overlooked when measuring indicators of birth preparedness among multiple audiences for program evaluation purposes in household-based surveys. Solutions are proposed to address each of these problems in an effort to improve future research.

Cumulative effects of heat exposure and storage conditions of Oxytocin-in-Uniject in rural Ghana: implications for scale up.

OBJECTIVE: Postpartum hemorrhage can be reduced substantially in home deliveries attended by community-based workers by using Oxytocin-in-Uniject (OIU) devices affixed with temperature-time indicators. We characterized the distribution of time to discard of these devices when stored under normal field conditions in Ghana. METHODS: Two drug storage simulation studies were conducted in rural Ghana in 2011 and 2012. Devices were transported under refrigeration from manufacture (Argentina) to storage at the study site. Twenty-three field workers each stored at home (unrefrigerated) 25 OIU devices and monitored them daily to record: (1) time to transition from usable to unusable, and (2) continuous digital ambient temperature to determine heat exposure over the simulation period. Time to discard was estimated and compared with mean kinetic temperature exposure of the devices during the shipment and storage phases and with characteristics of the storage locations using Weibull regression models. We used the time to discard distributions in a Monte Carlo simulation to estimate wastage rates in a hypothetical program setting. RESULTS: Time for shipment and transfer to long-term refrigerated storage and mean kinetic temperature during the shipment phase was 8.6 days/10.3°C and 13.4 days/12.1°C, for the first and second simulation studies, respectively. Median (range) time to discard when stored under field conditions (unrefrigerated) was 43 (6 to 59) days and 33 (14 to 50) days, respectively. Mean time to discard was 10.0 days shorter in the second simulation, during which mean kinetic temperature exposure was 3.9°C higher. Simulating a monthly distribution system and assuming typical usage, predicted wastage of product was less than 10%. CONCLUSION: The time to discard of devices was highly sensitive to small changes in temperature exposure. Under field conditions typical in rural Ghana, OIU packages will have a half-life of approximately 30 to 40 days based on the temperature monitor used during the study. Program managers will need to carefully consider variations in both ambient temperature and rate of use to allocate the appropriate supply level that will maximize coverage and minimize stock loss.

Direct observation of uterotonic drug use at public health facility-based deliveries in four districts in India.

OBJECTIVE: To describe intrapartum uterotonic drug use and related behaviors in public health facility-based deliveries and to describe drug storage conditions in associated pharmacies. METHODS: A descriptive study was conducted between August and November 2011 to document practices related to uterotonic administration and storage based on direct observation of deliveries at public health facilities in four Indian districts (n=97, n=89, n=91, and n=89) with contrasting maternal health and socioeconomic indicators. RESULTS: Uterotonic drug use before and after delivery was common among the 366 study participants. Labor augmentation rates ranged from 53.5%-93.0% of deliveries across districts, with many receiving multiple uterotonics and administration via intramuscular injection or intravenous push. Uterotonic use following delivery ranged from 78.6%-99.1% across districts, with correct use of uterotonics for postpartum hemorrhage prevention varying from 6.0%-8.8% in Uttar Pradesh and 41.2%-76.4% in Karnataka. Active management of the third stage of labor following Indian guidelines was less than 10% in all districts. Storage of uterotonics at room temperature was common. CONCLUSION: Given that labor augmentation is nearly routine and at odds with Indian guideline recommendations, rigorous research is needed to assess maternal and fetal outcomes of current versus guidelines-based practice. Active management of the third stage of labor as per Indian guidelines was minimal.

Measuring coverage in MNCH: testing the validity of women's self-report of key maternal and newborn health interventions during the peripartum period in Mozambique.

BACKGROUND: As low-income countries strive to meet targets for Millennium Development Goals 4 and 5, there is growing need to track coverage and quality of high-impact peripartum interventions. At present, nationally representative household surveys conducted in low-income settings primarily measure contact with the health system, shedding little light on content or quality of care. The objective of this study is to validate the ability of women in Mozambique to report on facility-based care they and their newborns received during labor and one hour postpartum. METHODS AND FINDINGS: The study involved household interviews with women in Mozambique whose births were observed eight to ten months previously as part of a survey of the quality of maternal and newborn care at government health facilities. Of 487 women whose births were observed and who agreed to a follow-up interview, 304 were interviewed (62.4%). The validity of 34 indicators was tested using two measures: area under receiver operator characteristic curve (AUC) and inflation factor (IF); 27 indicators had sufficient numbers for robust analysis, of which four met acceptability criteria for both (AUC >0.6 and 0.75

Injections during labor and intrapartum-related hypoxic injury and mortality in rural southern Nepal.

OBJECTIVE: To estimate the association between unmonitored use of injections during labor and intrapartum-related neonatal mortality and morbidity among home births. METHODS: Recently delivered women in Sarlahi, Nepal, reported whether they had received injections during labor. Data on breathing and crying status at birth, time to first breath, respiratory rate, sucking ability, and lethargy were gathered. Neonatal respiratory depression (NRD) and encephalopathy (NE) were compared by injection receipt status using multivariate regression models. RESULTS: Injections during labor were frequently reported (7108 of 22352 [31.8%]) and were predominantly given by unqualified village "doctors." Multivariate analysis (excluding facility births and complicated deliveries) revealed associations with intrapartum-related NRD (relative risk [RR] 2.52; 95% CI, 2.29-2.78) and NE (RR 3.48; 95% CI, 2.46-4.93). The risks of neonatal death associated with intrapartum-related NRD (RR 3.78; 95% CI, 2.53-5.66) or NE (RR 4.47; 95% CI, 2.78-7.19) were also elevated. CONCLUSION: Injection during labor was widespread at the community level. This practice was associated with poor outcomes and possibly related to the inappropriate use of uterotonics by unqualified providers. Interventions are required to increase the safety of childbirth in the community and in peripheral health facilities. Parent trial registered at clinicaltrials.gov (NCT00 109616).

Assessing the quality of cesarean birth data in the Demographic and Health Surveys.

Cesarean section surgery is the clinical response used to prevent several of the leading causes of maternal and perinatal mortality and morbidity. Given the deficient state of health-information systems in most developing countries, nationally representative surveys are currently the most widely available source of population-based cesarean birth data. The purpose of this study is to assess the quality and internal consistency of Demographic and Health Survey cesarean birth data across countries and time periods. Although these surveys are highly standardized, the formulation of the question on cesarean birth and the categories of women who are asked the question often differ across surveys. A skip pattern that restricts the cesarean question to women who delivered in a health-care facility improves the internal consistency of the data, although in some countries cesarean deliveries are still reported at low-level, presumably nonsurgical facilities. Recommendations are made for improving data analysis and the future collection of population-based cesarean birth data.

Levels and trends in cesarean birth in the developing world.

Evidence suggests that cesarean birth rates are high and increasing in some developing countries. The objectives of this study are to compile the best current estimate of cesarean birth rates for developing countries, to estimate regional rates, and to document trends nationally and by urban/rural residence where data permit. A database of cesarean birth rates was compiled representing 90 percent of births in the developing world, resulting in an estimated cesarean birth rate for the developing world of 12 percent, with regional rates ranging from 3 to 26 percent. Data representing 45 percent of births in the developing world show that a majority of countries experienced increases in cesarean birth rates during the 1990s, except in sub-Saharan African countries, where little if any change occurred. Cesarean birth rates must be monitored routinely to call attention to rapidly changing practices. These data can, in turn, trigger investigation into the appropriateness of the rate in a given context.

Reliability of data on caesarean sections in developing countries.

OBJECTIVE: To examine the reliability of reported rates of caesarean sections from developing countries and make recommendations on how data collection for surveys and health facility-based studies could be improved. METHODS: Population-based rates for caesarean section obtained from two sources: Demographic and Health Surveys (DHS) and health facility-based records of caesarean sections from the Unmet Obstetric Need Network, together with estimates of the number of live births, were compared for six developing countries. Sensitivity analyses were conducted using several different definitions of the caesarean section rate, and the rates obtained from the two data sources were compared. FINDINGS: The DHS rates for caesarean section were consistently higher than the facility-based rates. However, in three quarters of the cases, the facility-based rates for caesarean sections fell within the 95% confidence intervals for the DHS estimate. CONCLUSION: The importance of the differences between these two series of rates depends on the analyst's perspective. For national and global monitoring, DHS data on caesarean sections would suffice, although the imprecision of the rates would make the monitoring of trends difficult. However, the imprecision of DHS data on caesarean sections precludes their use for the purposes of programme evaluation at the regional level.