Autoimmune conditions in the World Trade Center general responder cohort: A nested case-control and standardized incidence ratio analysis.

BACKGROUND: The World Trade Center (WTC) general responder cohort (GRC) was exposed to environmental toxins possibly associated with increased risk of developing autoimmune conditions. OBJECTIVES: Two study designs were used to assess incidence and risks of autoimmune conditions in the GRC. METHODS: Three clinically trained professionals established the status of possible GRC cases of autoimmune disorders adhering to diagnostic criteria, supplemented, as needed, by specialists' review of consenting responders' medical records. Nested case-control analyses using conditional logistic regression estimated the risk associated with high WTC exposure (being in the 9/11/2001 dust cloud or ≥median days' response worked) compared with low WTC exposure (all other GRC members'). Four controls were matched to each case on age at case diagnosis (±2 years), sex, race/ethnicity, and year of program enrollment. Sex-specific and sensitivity analyses were performed. GRC age- and sex-adjusted standardized incidence ratios (SIRs) were compared with the Rochester Epidemiology Project (REP). Complete REP inpatient and outpatient medical records were reviewed by specialists. Conditions meeting standardized criteria on ≥2 visits were classified as REP confirmed cases. RESULTS: Six hundred and twenty-eight responders were diagnosed with autoimmune conditions between 2002 and 2017. In the nested case-control analyses, high WTC exposure was not associated with autoimmune domains and conditions (rheumatologic domain odds ratio [OR] = 1.03, 95% confidence interval [CI] = 0.77, 1.37; rheumatoid arthritis OR = 1.12, 95% CI = 0.70, 1.77). GRC members had lower SIR than REP. Women's risks were generally greater than men's. CONCLUSIONS: The study found no statistically significant increased risk of autoimmune conditions with WTC exposures.

Cardiovascular disease in the World Trade Center Health Program General Responder Cohort.

BACKGROUND: Over 90,000 rescue and recovery responders to the September 2001 World Trade Center (WTC) attacks were exposed to toxic materials that can impair cardiac function and increase cardiovascular disease (CVD) risk. We examined WTC-related exposures association with annual and cumulative CVD incidence and risk over 17 years in the WTC Health Program (HP) General Responder Cohort (GRC). METHODS: Post 9/11 first occurrence of CVD was assessed in 37,725 responders from self-reported physician diagnosis of, or current treatment for, coronary artery disease, myocardial infarction, stroke and/or congestive heart failure from WTCHP GRC monitoring visits. Kaplan-Meier estimates of CVD incidence used the generalized Wilcoxon test statistic to account for censored data. Cox proportional hazards regression analyses estimated the CVD hazard ratio associated with 9/11/2001 arrival in responders with and without dust cloud exposure, compared with arrival on or after 9/12/2001. Additional analyses adjusted for comorbidities. RESULTS: To date, 6.3% reported new CVD. In covariate-adjusted analyses, men's CVD 9/11/2001 arrival risks were 1.40 (95% confidence interval [CI] = 1.26, 1.56) and 1.43 (95% CI = 1.29, 1.58) and women's were 2.16 (95% CI = 1.49, 3.11) and 1.59 (95% CI = 1.11, 2.27) with and without dust cloud exposure, respectively. Protective service employment on 9/11 had higher CVD risk. CONCLUSIONS: WTCHP GRC members with 9/11/2001 exposures had substantially higher CVD risk than those initiating work afterward, consistent with observations among WTC-exposed New York City firefighters. Women's risk was greater than that of men's. GRC-elevated CVD risk may also be occurring at a younger age than in the general population.

Utility of anesthetic block for endometrial ablation pain: a randomized controlled trial.

BACKGROUND: Second-generation endometrial ablation has been demonstrated safe for abnormal uterine bleeding treatment, in premenopausal women who have completed childbearing, in short-stay surgical centers and in physicians' offices. However, no standard regarding anesthesia exists, and practice varies depending on physician or patient preference and hospital policy and setting. OBJECTIVE: The aim of this study was to evaluate whether local anesthetic, in combination with general anesthesia, affects postoperative pain and associated narcotic use following endometrial ablation. MATERIALS AND METHODS: This was a single-center single-blind randomized controlled trial conducted in an academic-affiliated community hospital. A total of 84 English-speaking premenopausal women, aged 30 to 55 years, who were undergoing outpatient endometrial ablation for benign disease were randomized to receive standardized paracervical injection of 20 mL 0.25% bupivacaine (treatment group) or 20 mL normal saline solution (control group) upon completion of ablation. The study was designed to test a 40% 1-hour mean visual analog scale (VAS) pain score difference with an average standard deviation of 75% of both groups' mean VAS scores, using a 2-tailed test, a type I error of 5%, and statistical power of 80%. A sample of 36 patients per study group was required. Assuming a 15% attrition rate, the study enrolled 42 patients per study arm randomized in blocks of 2 (84 total). Two-tailed cross-tabulations with Fisher exact significance values where appropriate and Student t tests were used to compare patient characteristics. Backward stepwise regressions were conducted to control for confounding. RESULTS: Between April 2016 and February 2017, a total of 108 women scheduled for endometrial ablation were screened (refusals, n = 21; ineligible, n = 3) to determine whether there were meaningful differences in postoperative VAS pain scores and postoperative narcotic use. Of the 84 randomized women, 2 age-ineligible women were excluded. Intent-to-treat analyses included 1 incorrect randomization (in which the provider consciously decided to provide analgesia regardless of the protocol, after which the provider was excluded from further study participation) and 3 women having no ablation because of operative difficulties. Three were lost to second-day follow-up. Treatment group patients (n = 41) experienced 1.3 points lower 1-hour postoperative VAS pain scores than the control group (n = 41, P = .02). The difference diminished by 4 hours (P = .31) and was negligible by 8 hours (P = .62). Treatment group patients used 3.6 less morphine equivalents of postoperative pain medication (P = .05). Regression analyses controlled for confounding reduced the 1-hour postoperative treatment group pain score difference to 0.8 (confidence interval [CI], -0.6 to 0.1) but slightly increased the average postoperative morphine equivalents to 3.7 (CI, -6.8 to -0.7). CONCLUSION: This randomized controlled trial found that local anesthetic with low risk for complications, used in conjunction with general anesthesia, decreased postoperative pain at 1 hour and significantly reduced postoperative narcotic use following endometrial ablation. Further research is needed to determine whether the study results are generalizable and whether post procedure is the best time to administer the paracervical block to decrease endometrial ablation pain.

Advancing Survival in Nigeria: A Pre-post Evaluation of an Integrated Maternal and Neonatal Health Program.

Introduction Nigeria contributes more obstetric, postpartum and neonatal deaths and stillbirths globally than any other country. The Clinton Health Access Initiative in partnership with the Nigerian Federal Ministry of Health and the state Governments of Kano, Katsina, and Kaduna implemented an integrated Maternal and Neonatal Health program from July 2014. Up to 90% women deliver at home in Northern Nigeria, where maternal mortality ratio and neonatal mortality rates (MMR and NMR) are high and severe challenges to improving survival exist. Methods Community-based leaders ("key informants") reported monthly vital events. Pre-post comparisons of later (months 16-18) with conservative baseline (months 7-9) rates were used to assess change in MMR, NMR, perinatal mortality (PMR) and stillbirth. Two-tailed cross-tabulations and unadjusted and adjusted logistic regression analyses were conducted. Results Data on 147,455 births (144,641 livebirths and 4275 stillbirths) were analyzed. At endline (months 16-18), MMR declined 37% (OR 0.629, 95% CI 0.490-0.806, p ≤ 0.0003) vs. baseline 440/100,000 births (months 7-9). NMR declined 43% (OR 0.574, 95% CI 0.503-0.655, p < 0.0001 vs. baseline 15.2/1000 livebirths. Stillbirth rates declined 15% (OR 0.850, 95% CI 0.768-0.941, p = 0.0018) vs. baseline 21.1/1000 births. PMR declined 27% (OR 0.733, 95% CI 0.676-0.795, p < 0.0001) vs. baseline 36.0/1000 births. Adjusted results were similar. Discussion The findings are similar to the Cochrane Review effects of community-based interventions and indicate large survival improvements compared to much slower global and flat national trends. Key informant data have limitations, however, their limitations would have little effect on the results magnitude or significance.

Bowel injury in robotic gynecologic surgery: risk factors and management options. A systematic review.

OBJECTIVE: We sought to analyze the published literature on bowel injuries in patients undergoing gynecologic robotic surgery with the aim to determine its incidence, predisposing factors, and treatment options. DATA SOURCES: Studies included in this analysis were identified by searching PubMed Central, OVID Medline, EMBASE, Cochrane, and ClinicalTrials.gov databases. References for all studies were also reviewed. Time frame for data analysis spanned from November 2001 through December 2014. STUDY ELIGIBILITY CRITERIA: All English-language studies reporting the incidence of bowel injury or complications during robotic gynecologic surgery were included. Studies with data duplication, not in English, case reports, or studies that did not explicitly define bowel injury incidence were excluded. STUDY APPRAISAL AND SYNTHESIS METHODS: The Guidelines for Meta-Analyses and Systematic Reviews of Observational Studies were used to complete the systematic review with the exception of scoring study quality and a single primary reviewer. RESULTS: In all, 370 full-text articles were reviewed and 144 met the inclusion criteria. There were 84 bowel injuries recorded in 13,444 patients for an incidence of 1 in 160 (0.62%; 95% confidence interval, 0.50-0.76%). There were no significant differences in incidence of bowel injury by procedure type. The anatomic location of injury, etiology, and management were rarely reported. Of the bowel injuries, 87% were recognized intraoperatively and the majority (58%) managed via a minimally invasive approach. Of 13,444 patients, 3 (0.02%) (95% confidence interval, 0.01-0.07%) died in the immediate postoperative period and no deaths were a result of a bowel injury. CONCLUSION: The overall incidence of bowel injury in robotic-assisted gynecologic surgery is 1 in 160. When the location of bowel injuries were specified, they most commonly occurred in the colon and rectum and most were managed via a minimally invasive approach.

Traditional Versus Simulation Resident Surgical Laparoscopic Salpingectomy Training: A Randomized Controlled Trial.

STUDY OBJECTIVES: To evaluate the effectiveness of the porcine training model for obstetrics-gynecology (OB/GYN) residents in laparoscopic salpingectomy. DESIGN: Randomized, controlled single-blinded trial. CLASSIFICATION: Canadian Task Force Classification I. SETTING: A large community-based teaching hospital. PARTICIPANTS: All postgraduate year 1 through year 4 OB/GYN residents were enrolled (n = 22). INTERVENTION: All participants underwent a preintervention objective skills assessment test (OSAT), in which the participant performed live human laparoscopic salpingectomy. Residents were randomly assigned (using a computer-generated randomization table, in blocks of 2, stratified by ranked baseline OSAT scores) to the intervention or control group. The intervention group consisted of 1 educational session with presession assigned reading, a 40-min didactic lecture, viewing of a procedural video, and simulation and practice of laparoscopic salpingectomy on a porcine cadaver. The control group received traditional training per routine residency rotations. MEASUREMENTS AND MAIN RESULTS: Laparoscopic salpingectomy was performed on live patients by study participants pre- and postintervention. These procedures were video recorded, and then scored by a single blinded evaluator of the OSATs. Nine pre- and postintervention OSAT indicators, reflecting provider knowledge and skill, were the primary outcome measures. Secondary outcomes were the changes in 10 subjective measures of comfort, assessed by a pre- and postintervention survey. The outcomes were assessed using 5-point Likert scales (for OSATs 1 = lowest score; for the subjective survey 1 = highest score). The control group OSAT scores did not change (pre: 26.6 ± 10.8, post: 26.2 ± 10.1; p = .65). There were significant improvements in 2-handed surgery (pre: 2.8 ± 1.6, post: 3.5 ± 1.3; p = .004) and use of energy (pre: 2.9 ± 1.3, post: 3.6 ± 1.0; p = .01) in the intervention group, contributing to an overall score change (pre: 26.7 ± 10.6, post: 29.9 ± 9.8; p ≤ .001). The control group had no change in comfort levels. The intervention group experienced both increases (anatomy, steps of surgery, 2-handed surgery, and use of energy) and decreases (reading and learning in operating room) in reported comfort levels. CONCLUSION: This study demonstrates that simulation can improve surgical technique OSATs. However, of 45 possible points, both groups' average scores were <70% of the optimum. Thus, the improvement, although statistically significant, was relatively small and indicates that further supplementation in training is needed to substantially increase the residents' surgical skills.

An Intervention to Enhance Obstetric and Newborn Care in India: A Cluster Randomized-Trial.

OBJECTIVES: This study assessed whether community mobilization and interventions to improve emergency obstetric and newborn care reduced perinatal mortality (PMR) and neonatal mortality rates (NMR) in Belgaum, India. METHODS: The cluster-randomised controlled trial was conducted in Belgaum District, Karnataka State, India. Twenty geographic clusters were randomized to control or the intervention. The intervention engaged and mobilized community and health authorities to leverage support; strengthened community-based stabilization, referral, and transportation; and aimed to improve quality of care at facilities. RESULTS: 17,754 Intervention births and 15,954 control births weighing ≥1000 g, respectively, were enrolled and analysed. Comparing the baseline period to the last 6 months period, the NMR was lower in the intervention versus control clusters (OR 0.60, 95% CI 0.34-1.06, p = 0.076) as was the PMR (OR 0.74, 95% CI 0.46-1.19, p = 0.20) although neither reached statistical significance. Rates of facility birth and caesarean section increased among both groups. There was limited influence on quality of care measures. CONCLUSIONS FOR PRACTICE: The intervention had large but not statistically significant effects on neonatal and perinatal mortality. Community mobilization and increased facility care may ultimately improve neonatal and perinatal survival, and are important in the context of the global transition towards institutional delivery.

Institutional deliveries and perinatal and neonatal mortality in Southern and Central India.

BACKGROUND: Skilled birth attendance and institutional delivery have been advocated for reducing maternal, perinatal and neonatal mortality (PMR and NMR). India has successfully implemented various strategies to promote skilled attendance and incentivize institutional deliveries in the last 5 years. OBJECTIVES: The study evaluates the trends in institutional delivery, PMR, NMR, and their risk factors in two Eunice Kennedy Shriver NICHD Global Network for Women's and Children's Health Research sites, in Belgaum and Nagpur, India, between January 2010 and December 2013. DESIGN/METHODS: Descriptive data stratified by level of delivery care and key risk factors were analyzed for 36 geographic clusters providing 48 months of data from a prospective, population-based surveillance system that registers all pregnant permanent residents in the study area, and their pregnancy outcomes irrespective of where they deliver. Log binomial models with generalized estimating equations to control for correlation of clustered observations were used to test the trends significance RESULTS: 64,803 deliveries were recorded in Belgaum and 39,081 in Nagpur. Institutional deliveries increased from 92.6% to 96.1% in Belgaum and from 89.5% to 98.6% in Nagpur (both p<0.0001); hospital rates increased from 63.4% to 71.0% (p=0.002) and from 63.1% to 72.0% (p<0.0001), respectively. PMR declined from 41.3 to 34.6 (p=0.008) deaths per 1,000 births in Belgaum and from 47.4 to 40.8 (p=0.09) in Nagpur. Stillbirths also declined, from 22.5 to 16.3 per 1,000 births in Belgaum and from 29.3 to 21.1 in Nagpur (both p=0.002). NMR remained unchanged. CONCLUSIONS: Significant increases in institutional deliveries, particularly in hospitals, were accompanied by reductions in stillbirths and PMR, but not by NMR.

A comparison of two user-friendly methods to identify and support correction of misspelled medications.

Objective: To identify and support correction of misspelled medication names recorded as free text, we compared the relative effectiveness of two user-friendly methods, used without reliance on clinical knowledge. Methods: Leveraging the SAS® COMPGED function, fuzzy string search programs examined 1.8 million medication records from 183,600 World Trade Center General Responder Cohort monitoring visits conducted in New York and New Jersey between 7/16/2002 and 3/31/2021, producing replicable generalized edit distance scores between the reported and correct spelling. Scores < 120 were selected as optimal and compared to Stedman's 2020 Plus Medical/Pharmaceutical Spell Checker first suggested word, used as the comparative standard because it employs both spelling and phonetic similarities to suggest matching words. We coded each methods' results as identifying or not identifying the medications within each visit. Results: Most types of medications (94.4 % anxiety, 98.4 % asthma and 94.6 % ulcer/gastroesophageal reflux disease) were correctly spelled. Cross tabulations assessed the agreement (anxiety 99.9 %, asthma 99.6 % and 98.4 % ulcer/ gastroesophageal reflux disease), false positive (respectively 0.02 %, 0.03 % and 2.0 %) and false negative (respectively 1.9 %, 0.5 % and 1.0 %) values. Scores < 120 occasionally correctly identified medications missed by the spell checker. We observed no difference in medication misspellings across socio-economically and culturally diverse patient characteristics. Conclusions: Both methods efficiently identified most misspelled medications, greatly minimizing the review and rectification needed. The fuzzy method is more universally applicable for condition-specific medications identification, but requires more programming skills. The spell checker is inexpensive, but benefits from modest programming skills and is only available in some languages.

Advancing maternal survival in the global context: are our strategies working?

There have been significant gains in improving maternal mortality over the last two decades. Researchers have suggested a variety of interventions and mechanisms to explain these improvements. While it is likely that much of what has been done in research and programs has contributed to this decline, the evidence regarding what works in the settings in which women deliver continues to face many challenges. We review the evidence for these improvements and suggest that there remain areas to focus on, particularly the births which currently take place in an unsupervised or substandard environments. We highlight the main areas where more evidence is needed, and end with a call to determine which of our interventions seem to have the most benefit; which do not; and where to invest future resources.

Midwife-performed checklist and ultrasound to identify obstetric conditions at labour triage in Uganda: A quasi-experimental study.

OBJECTIVE: The aim of this study was to evaluate the effect of a midwife-performed checklist and limited obstetric ultrasound on sensitivity and positive predictive value for a composite outcome comprising multiple gestation, placenta praevia, oligohydramnios, preterm birth, malpresentation, abnormal foetal heart rate. DESIGN: Quasi-experimental pre-post intervention study. SETTING: Maternity unit at a district hospital in Eastern Uganda. INTERVENTIONS: Interventions were implemented in a phased approach: standardised labour triage documentation (Phase 1), a triage checklist (Phase 2), and checklist plus limited obstetric ultrasound (Phase 3). PARTICIPANTS: Consenting women presenting to labour triage for admission after 28 weeks of gestation between February 2018 and June 2019 were eligible. Women not in labour or those requiring immediate care were excluded. 3,865 women and 3,937 newborns with similar sample sizes per phase were included in the analysis. MEASUREMENT AND FINDINGS: Outcome data after birth were used to determine true presence of a complication, while intake and checklist data were used to inform diagnosis before birth. Compared to Phase 1, Phase 2 and 3 interventions improved sensitivity (Phase 1: 47%, Phase 2: 68.8%, Phase 3: 73.5%; p ≤ 0.001) and reduced positive predictive value (65.9%, 55%, 48.7%, p ≤ 0.001) for the composite outcome. No phase differences in adverse maternal or foetal outcomes were observed. CONCLUSION: Both a triage checklist and a checklist plus limited obstetric ultrasound improved accurate identification of cases with some increase in false positive diagnosis. These interventions may be beneficial in a resource-limited maternity triage setting to improve midwives' diagnoses and clinical decision-making.

Effect of a labor triage checklist and ultrasound on obstetric referral at three primary health centers in Eastern Uganda.

OBJECTIVE: To test whether introduction of a midwife-performed triage checklist and focused ultrasound improves diagnosis and referral for obstetric conditions, including multiple gestation, placenta previa, oligohydramnios, preterm birth, malpresentation, and abnormal fetal heart rate. METHODS: We implemented an intake log (Phase 1), a checklist (Phase 2), and a checklist plus ultrasound scan (Phase 3) at three primary health centers in Eastern Uganda for women presenting in labor. Intake diagnoses, referral status, and delivery outcomes were assessed, as well as sensitivity and positive predictive value (PPV). RESULTS: Between February 2018 and July 2019, 1155, 961, and 603 women were enrolled across the three phases (n=2719); 2339 had outcome data. Incidence of any outcome-confirmed condition was 8.8%, 7.9%, and 7.1% (P=0.526) for each phase, respectively. The proportion of referred women with a condition did not change between Phases 1 and 2 (7.8% versus 8.6%, P=0.855), but increased in Phase 3 (48.4%, P<0.001). Sensitivity improved with each intervention; PPV decreased with ultrasound. CONCLUSION: Use of ultrasound plus checklist increased referrals and sensitivity for high-risk conditions, with decreased PPV. The checklist alone improved correct diagnosis, but not referral. Further evaluation of these triage interventions to maximize diagnostic accuracy, referral decisions, and outcomes are warranted.

Assessing the impact of group antenatal care on gestational length in Rwanda: A cluster-randomized trial.

BACKGROUND: Research on group antenatal care in low- and middle-income contexts suggests high acceptability and preliminary implementation success. METHODS: We studied the effect of group antenatal care on gestational age at birth among women in Rwanda, hypothesizing that participation would increase mean gestational length. For this unblinded cluster randomized trial, 36 health centers were pair-matched and randomized; half continued individual antenatal care (control), half implemented group antenatal care (intervention). Women who initiated antenatal care between May 2017 and December 2018 were invited to participate, and included in analyses if they presented before 24 weeks gestation, attended at least two visits, and their birth outcome was obtained. We used a generalized estimating equations model for analysis. FINDINGS: In total, 4091 women in 18 control clusters and 4752 women in 18 intervention clusters were included in the analysis. On average, women attended three total antenatal care visits. Gestational length was equivalent in the intervention and control groups (39.3 weeks (SD 1.6) and 39.3 weeks (SD 1.5)). There were no significant differences between groups in secondary outcomes except that more women in control sites attended postnatal care visits (40.1% versus 29.7%, p = 0.003) and more women in intervention sites attended at least three total antenatal care visits (80.7% versus 71.7%, p = 0.003). No harms were observed. INTERPRETATION: Group antenatal care did not result in a difference in gestational length between groups. This may be due to the low intervention dose. We suggest studies of both the effectiveness and costs of higher doses of group antenatal care among women at higher risk of preterm birth. We observed threats to group care due to facility staff shortages; we recommend studies in which antenatal care providers are exclusively allocated to group antenatal care during visits. TRIAL REGISTRATION: ClinicalTrials.gov NCT03154177.

Pregnancy outcomes in facility deliveries in Kenya and Uganda: A large cross-sectional analysis of maternity registers illuminating opportunities for mortality prevention.

INTRODUCTION: As facility-based deliveries increase globally, maternity registers offer a promising way of documenting pregnancy outcomes and understanding opportunities for perinatal mortality prevention. This study aims to contribute to global quality improvement efforts by characterizing facility-based pregnancy outcomes in Kenya and Uganda including maternal, neonatal, and fetal outcomes at the time of delivery and neonatal discharge outcomes using strengthened maternity registers. METHODS: Cross sectional data were collected from strengthened maternity registers at 23 facilities over 18 months. Data strengthening efforts included provision of supplies, training on standard indicator definitions, and monthly feedback on completeness. Pregnancy outcomes were classified as live births, early stillbirths, late stillbirths, or spontaneous abortions according to birth weight or gestational age. Discharge outcomes were assessed for all live births. Outcomes were assessed by country and by infant, maternal, and facility characteristics. Maternal mortality was also examined. RESULTS: Among 50,981 deliveries, 91.3% were live born and, of those, 1.6% died before discharge. An additional 0.5% of deliveries were early stillbirths, 3.6% late stillbirths, and 4.7% spontaneous abortions. There were 64 documented maternal deaths (0.1%). Preterm and low birthweight infants represented a disproportionate number of stillbirths and pre-discharge deaths, yet very few were born at ≤1500g or <28w. More pre-discharge deaths and stillbirths occurred after maternal referral and with cesarean section. Half of maternal deaths occurred in women who had undergone cesarean section. CONCLUSION: Maternity registers are a valuable data source for understanding pregnancy outcomes including those mothers and infants at highest risk of perinatal mortality. Strengthened register data in Kenya and Uganda highlight the need for renewed focus on improving care of preterm and low birthweight infants and expanding access to emergency obstetric care. Registers also permit enumeration of pregnancy loss <28 weeks. Documenting these earlier losses is an important step towards further mortality reduction for the most vulnerable infants.

Effect of a quality improvement package for intrapartum and immediate newborn care on fresh stillbirth and neonatal mortality among preterm and low-birthweight babies in Kenya and Uganda: a cluster-randomised facility-based trial.

BACKGROUND: Although gains in newborn survival have been achieved in many low-income and middle-income countries, reductions in stillbirth and neonatal mortality have been slow. Prematurity complications are a major driver of stillbirth and neonatal mortality. We aimed to assess the effect of a quality improvement package for intrapartum and immediate newborn care on stillbirth and preterm neonatal survival in Kenya and Uganda, where evidence-based practices are often underutilised. METHODS: This unblinded cluster-randomised controlled trial was done in western Kenya and eastern Uganda at facilities that provide 24-h maternity care with at least 200 births per year. The study assessed outcomes of low-birthweight and preterm babies. Eligible facilities were pair-matched and randomly assigned (1:1) into either the intervention group or the control group. All facilities received maternity register data strengthening and a modified WHO Safe Childbirth Checklist; facilities in the intervention group additionally received provider mentoring using PRONTO simulation and team training as well as quality improvement collaboratives. Liveborn or fresh stillborn babies who weighed between 1000 g and 2500 g, or less than 3000 g with a recorded gestational age of less than 37 weeks, were included in the analysis. We abstracted data from maternity registers for maternal and birth outcomes. Follow-up was done by phone or in person to identify the status of the infant at 28 days. The primary outcome was fresh stillbirth and 28-day neonatal mortality. This trial is registered with ClinicalTrials.gov, NCT03112018. FINDINGS: Between Oct 1, 2016, and April 30, 2019, 20 facilities were randomly assigned to either the intervention group (n=10) or the control group (n=10). Among 5343 eligible babies in these facilities, we assessed outcomes of 2938 newborn and fresh stillborn babies (1447 in the intervention and 1491 in the control group). 347 (23%) of 1491 infants in the control group were stillborn or died in the neonatal period compared with 221 (15%) of 1447 infants in the intervention group at 28 days (odds ratio 0·66, 95% CI 0·54-0·81). No harm or adverse effects were found. INTERPRETATION: Fresh stillbirth and neonatal mortality among low-birthweight and preterm babies can be decreased using a package of interventions that reinforces evidence-based practices and invests in health system strengthening. FUNDING: Bill & Melinda Gates Foundation.

Oxytocin via Uniject (a prefilled single-use injection) versus oral misoprostol for prevention of postpartum haemorrhage at the community level: a cluster-randomised controlled trial.

BACKGROUND: Access to injectable uterotonics for management of postpartum haemorrhage remains limited in Senegal outside health facilities, and misoprostol and oxytocin delivered via Uniject have been deemed viable alternatives in community settings. We aimed to compare the efficacy of these drugs when delivered by auxiliary midwives at maternity huts. METHODS: We did an unmasked cluster-randomised controlled trial at maternity huts in three districts in Senegal. Maternity huts with auxiliary midwives located 3-21 km from the closest referral centre were randomly assigned (1:1; via a computer-generated random allocation overseen by Gynuity Health Projects) to either 600 µg oral misoprostol or 10 IU oxytocin in Uniject (intramuscular), stratified by reported previous year clinic volume (deliveries) and geographical location (inland or coastal). Maternity huts that had been included in a previous study of misoprostol for prevention of postpartum haemorrhage were excluded to prevent contamination. Pregnant women in their third trimester were screened for eligibility either during community outreach or at home-based prenatal visits. Only women delivered by the auxiliary midwives in the maternity huts were eligible for the study. Women with known allergies to prostaglandins or pregnancy complications were excluded. The primary outcome was mean change in haemoglobin concentration measured during the third trimester and after delivery. This study was registered with ClinicalTrials.gov, number NCT01713153. FINDINGS: 28 maternity hut clusters were randomly assigned-14 to the misoprostol group and 14 to the oxytocin group. Between June 6, 2012, and Sept 21, 2013, 1820 women were recruited. 647 women in the misoprostol group and 402 in the oxytocin group received study drug and had recorded pre-delivery and post-delivery haemoglobin concentrations, and overall 1412 women delivered in the study maternity huts. The mean change in haemoglobin concentrations was 3·5 g/L (SD 16·1) in the misoprostol group and 2·7 g/L (SD 17·8) in the oxytocin group. When adjusted for cluster design, the mean difference in haemoglobin decreases between groups was not significant (0·3 g/L, 95% CI -8·26 to 8·92, p=0·71). Both drugs were well tolerated. Shivering was common in the misoprostol group, and nausea in the oxytocin group. Postpartum haemorrhage was diagnosed in one woman allocated to oxytocin, who was referred and transferred to a higher-level facility for additional care, and fully recovered. No other women were transferred. INTERPRETATION: In terms of effects on haemoglobin concentrations, neither oxytocin nor misoprostol was significantly better than the other, and both drugs were safe and efficacious when delivered by auxiliary midwives. The programmatic limitations of oxytocin, including short shelf life outside the cold chain, mean that misoprostol could be more appropriate for community-level prophylaxis of postpartum haemorrhage. FUNDING: Bill & Melinda Gates Foundation.

Incidence of postpartum infection after vaginal delivery in Viet Nam.

This study assessed the incidence of postpartum infection which is rarely clinically evaluated and is probably underestimated in developing countries. This prospective study identified infection after vaginal delivery by clinical and laboratory examinations prior to discharge from hospital and again at six weeks postpartum in Ho Chi Minh City, Viet Nam. Textbook definitions, physicians' diagnoses, symptomatic and verbal autopsy definitions were used for classifying infection. Logistic regression was used for determining associations of postpartum infection with socioeconomic and reproductive characteristics. In total, 978 consecutive, eligible consenting women were followed up at 42+/-7 (range 2-45) days postpartum (not associated with incidence). Ninety-eight percent took 'prophylactic' antibiotics. The most conservative estimate of the incidence of postpartum infection was 1.7%. The incidence of serious infection was 0.5%, but increased to 4.6% when verbal autopsy and symptomatic definitions were used. Postpartum infection, particularly serious infection, is greatly underestimated. Just preventing or treating infection could have a substantial impact on reducing maternal mortality in developing countries.

Adaptation of kangaroo mother care for community-based application.

OBJECTIVE: Working with a multidisciplinary team of Ecuadorians, Bangladeshis and Americans, we developed a simple protocol for community-based implementation of kangaroo mother care (CKMC) that does not require birth weight or clinical judgment to identify which newborns should receive CKMC. CKMC could stabilize newborns and possibly reduce neonatal mortality where there is little medical care for newborns and low birth weight (LBW) is common. STUDY DESIGN: During their CKMC training, community-based workers identified 35 expectant or recently delivered women in the pilot study area and taught them about CKMC. Women were interviewed at 1 month postpartum to evaluate their experience with CKMC. RESULTS: In all, 77% of mothers initiated skin-to-skin care and 85% with LBW babies did so (37% were LBW). CKMC mothers delayed newborn bathing. Few slept upright with their newborns. CONCLUSIONS: CKMC was quickly and popularly adopted. A randomized controlled cluster trial is planned to determine whether CKMC reduces neonatal mortality.