Nancy L. Sloan

Stillbirth and Newborn Mortality in India After Helping Babies Breathe Training

OBJECTIVE: This study evaluated the effectiveness of Helping Babies Breathe (HBB) newborn care and resuscitation training for birth attendants in reducing stillbirth (SB), and predischarge and neonatal mortality (NMR). India contributes to a large proportion of the worlds annual 3.1 million neonatal deaths and 2.6 million SBs. METHODS: This prospective study included 4187 births at >28 weeks’ gestation before and 5411 births after HBB training in Karnataka. A total of 599 birth attendants from rural primary health centers and district and urban hospitals received HBB training developed by the American Academy of Pediatrics, using a train-the-trainer cascade. Pre-post written trainee knowledge, posttraining provider performance and skills, SB, predischarge mortality, and NMR before and after HBB training were assessed by using χ2 and t-tests for categorical and continuous variables, respectively. Backward stepwise logistic regression analysis adjusted for potential confounding. RESULTS: Provider knowledge and performance systematically improved with HBB training. HBB training reduced resuscitation but increased assisted bag and mask ventilation incidence. SB declined from 3.0% to 2.3% (odds ratio [OR] 0.76, 95% confidence interval [CI] 0.59–0.98) and fresh SB from 1.7% to 0.9% (OR 0.54, 95% CI 0.37–0.78) after HBB training. Predischarge mortality was 0.1% in both periods. NMR was 1.8% before and 1.9% after HBB training (OR 1.09, 95% CI 0.80–1.47, P = .59) but unknown status at 28 days was 2% greater after HBB training (P = .007). CONCLUSIONS: HBB training reduced SB without increasing NMR, indicating that resuscitated infants survived the neonatal period. Monitoring and community-based assessment are recommended.

Prevention of postpartum haemorrhage with sublingual misoprostol or oxytocin: a double‐blind randomised controlled trial

Please cite this paper as: Bellad M, Tara D, Ganachari M, Mallapur M, Goudar S, Kodkany B, Sloan N, Derman R. Prevention of postpartum haemorrhage with sublingual misoprostol or oxytocin: a double‐blind randomised controlled trial. BJOG 2012;119:975–986.

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

BackgroundSkilled 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.ObjectivesThe 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/methodsDescriptive 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 significanceResults64,803 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.ConclusionsSignificant increases in institutional deliveries, particularly in hospitals, were accompanied by reductions in stillbirths and PMR, but not by NMR.

Establishment of a Maternal Newborn Health Registry in the Belgaum District of Karnataka, India

BackgroundPregnancy-related vital registration is important to inform policy to reduce maternal, fetal and newborn mortality, yet few systems for capturing accurate data are available in low-middle income countries where the majority of the mortality occurs. Furthermore, methods to effectively implement high-quality registration systems have not been described. The goal of creating the registry described in this paper was to inform public health policy makers about pregnancy outcomes in our district so that appropriate interventions to improve these outcomes could be undertaken and to position the district to be a leader in pregnancy-related public health research.MethodsWe created a prospective maternal and newborn health registry in Belgaum, Karnataka State, India. To initiate this registry, we worked with the Ministry of Health to first establish estimated birth rates and define the catchment areas of the clusters, working within the existing health system and primary health centers. We also undertook household surveys to identify women likely to become pregnant. We then implemented monitoring measures to ensure high quality and completeness of the maternal newborn health registry. All pregnant women in the catchment area were identified, consented and enrolled during pregnancy, with follow-up visits to ascertain pregnancy outcomes and mother/infant status at 42-days postpartum.ResultsFrom 2008 through 2014, we demonstrated continued improvements in both the coverage for enrollment and accuracy of reporting pregnancy outcomes within the defined catchment area in Belgaum, India. Nearly 100% of women enrolled had follow-up at birth and 99% had 42-day follow-up. Furthermore, we facilitated earlier enrollment of women during pregnancy while achieving more timely follow-up and decreased time of reporting from the date of the pregnancy event.ConclusionsWe created a pregnancy-related registry which includes demographic data, risk factors, and outcomes allowing for high rates of ascertainment and follow-up while working within the existing health system. Understanding the elements of the system used to create the registry is important to improve the quality of the results. Tracking of pregnancies and their outcomes is an important step toward reducing maternal and perinatal mortality.

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

STUDY OBJECTIVESnTo evaluate the effectiveness of the porcine training model for obstetrics-gynecology (OB/GYN) residents in laparoscopic salpingectomy.nnnDESIGNnRandomized, controlled single-blinded trial.nnnCLASSIFICATIONnCanadian Task Force Classification I.nnnSETTINGnA large community-based teaching hospital.nnnPARTICIPANTSnAll postgraduate year 1 through year 4 OB/GYN residents were enrolled (n = 22).nnnINTERVENTIONnAll 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.nnnMEASUREMENTS AND MAIN RESULTSnLaparoscopic 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.nnnCONCLUSIONnThis 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.

ObjectivesThis 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.MethodsThe 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.Results17,754 Intervention births and 15,954 control births weighing ≥1000xa0g, respectively, were enrolled and analysed. Comparing the baseline period to the last 6xa0months period, the NMR was lower in the intervention versus control clusters (OR 0.60, 95xa0% CI 0.34–1.06, pxa0=xa00.076) as was the PMR (ORxa00.74, 95xa0% CI 0.46–1.19, pxa0=xa00.20) 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 PracticeThe 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.

Evaluation of the Heart Truth Professional Education Campaign on Provider Knowledge of Women and Heart Disease

BACKGROUNDnThe Heart Truth Professional Education Campaign was developed to facilitate education of health care providers in evidence-based strategies to prevent cardiovascular disease (CVD) in women.nnnMETHODSnAs part of the 3-year campaign, lectures based on the American Heart Associations evidence-based guidelines for CVD prevention in women were presented by local speakers to healthcare providers and students in three high-risk states: Delaware, Ohio, and New York. Participants responses to pretest and posttest questions about CVD in women are presented. We performed t-test and multivariable linear regression to assess the influence of provider characteristics on baseline knowledge and knowledge change after the lecture.nnnRESULTSnBetween 2008 and 2011, 2,995 healthcare providers, students, and other participants completed the baseline assessment. Knowledge scores at baseline were highest for physicians, with obstetrician/gynecologists scoring lowest (63%) and cardiologists highest (76%). Nurses had intermediate total knowledge (56%) and students had the lowest total knowledge (49%) at baseline. Pre- and post-lecture assessments were completed by 1,893 (63%) of attendees. Scores were significantly higher after the educational lecture (p ≤ .001), with greater increase for those with lower baseline scores. Baseline knowledge of the use of statins, hormone therapy, and antioxidants, as well as approaches to smoking cessation and treatment of hypertension, differed by provider type.nnnCONCLUSIONnTailoring of lectures for non-physician audiences may be beneficial given differences in baseline knowledge. More emphasis is needed on statin use for all providers and on smoking cessation and treatment of hypertension for nurses, students, and other healthcare professionals.

Clindamycin to reduce preterm birth in a low resource setting: a randomised placebo‐controlled clinical trial

To determine whether oral clindamycin reduces the risk of preterm birth (PTB) in women with abnormal vaginal microflora as evidenced by a vaginal pH ≥5.0.

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, pu2009≤u20090.0003) vs. baseline 440/100,000 births (months 7–9). NMR declined 43% (OR 0.574, 95% CI 0.503–0.655, pu2009<u20090.0001 vs. baseline 15.2/1000 livebirths. Stillbirth rates declined 15% (OR 0.850, 95% CI 0.768–0.941, pu2009=u20090.0018) vs. baseline 21.1/1000 births. PMR declined 27% (OR 0.733, 95% CI 0.676–0.795, pu2009<u20090.0001) 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.

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.