Community level interventions for pre-eclampsia (CLIP) in India: A cluster randomised controlled trial.

OBJECTIVES: Pregnancy hypertension is associated with 7.1% of maternal deaths in India. The objective of this trial was to assess whether task-sharing care might reduce adverse pregnancy outcomes related to delays in triage, transport, and treatment. STUDY DESIGN: The Indian Community-Level Interventions for Pre-eclampsia (CLIP) open-label cluster randomised controlled trial (NCT01911494) recruited pregnant women in 12 clusters (initial four-cluster internal pilot) in Belagavi and Bagalkote, Karnataka. The CLIP intervention (6 clusters) consisted of community engagement, community health workers (CHW) provided mobile health (mHeath)-guided clinical assessment, initial treatment, and referral to facility either urgently (<4 h) or non-urgently (<24 h), dependent on algorithm-defined risk. Treatment effect was estimated by multi-level logistic regression modelling, adjusted for prognostically-significant baseline variables. Predefined secondary analyses included safety and evaluation of the intensity of mHealth-guided CHW-provided contacts. MAIN OUTCOME MEASURES: 20% reduction in composite of maternal, fetal, and newborn mortality and major morbidity. RESULTS: All 14,783 recruited pregnancies (7839 intervention, 6944 control) were followed-up. The primary outcome did not differ between intervention and control arms (adjusted odds ratio (aOR) 0.92 [95% confidence interval 0.74, 1.15]; p = 0.47; intraclass correlation coefficient 0.013). There were no intervention-related safety concerns following administration of either methyldopa or MgSO4, and 401 facility referrals. Compared with intervention arm women without CLIP contacts, those with ≥8 contacts suffered fewer stillbirths (aOR 0.19 [0.10, 0.35]; p < 0.001), at the probable expense of survivable neonatal morbidity (aOR 1.39 [0.97, 1.99]; p = 0.072). CONCLUSIONS: As implemented, solely community-level interventions focussed on pre-eclampsia did not improve outcomes in northwest Karnataka.

Mold remediation in a hospital.

As occupants in a hospital, patients are susceptible to air contaminants that can include biological agents dispersed throughout the premise. An exposed patient can become ill and require medical intervention. A consideration for patients is that they may have become environmentally sensitive and require placement in an environment that does not compromise their health. Unfortunately, the hospital environment often contains more biological substances than can be expected in an office or home environment. When a hospital also experiences water intrusion such as flooding or water leaks, resulting mold growth can seriously compromise the health of patients and others such as nursing staff and physicians (Burge, Indoor Air and Infectious Disease. Occupational Medicine: State of the Art Reviews, 1980; Lutz et al., Clinical Infectious Diseases 37: 786-793, 2003). Micro-organism growth can propagate if the water is not addressed quickly and effectively. Immunocompromised patients are particularly at risk when subjected to fungal infection such that the US Center for Disease Control issued guideline for building mold in health care facilities (Centers for Disease and Control [CDC], Centers for Disease and Control: Questions and Answers on Stachybotrys chartarum and Other Molds, 2000). This paper is based on mold remediation of one portion of a hospital unit due to water from construction activity and inadequate maintenance, resulting in mold growth. A large proportion of the hospital staff, primarily nurses in the dialysis unit, exhibited health symptoms consistent with mold exposure. Unfortunately, the hospital administrators did not consider the mold risk to be serious and refused an independent consultant retained by the nurse's union to examine the premise (Canadian Broadcasting Corporation [CBC], Nurses file complaints over mold at Foothills. Canadian Broadcasting Corporation, 2003). The nurse's union managed to have the premise examined by submitting a court order of detention and inspection and for an interlocutory injunction to allow their consultants to undertake air quality testing. Mold remediation procedures are readily available and are not to be discussed here (Silicato, http://www.nibs.org/BETEC/M6/ 13-Silicato_Mold-Remediation.pdf, 2004). However, the difficulty of determining the qualifications of consultants, contactors and project managers are discussed. It also describes the need and importance of a buffer zone between the occupied areas and the mold abatement containment area.

MAGnesium sulphate for fetal neuroprotection to prevent Cerebral Palsy (MAG-CP)-implementation of a national guideline in Canada.

BACKGROUND: Evidence supports magnesium sulphate (MgSO4) for women at risk of imminent birth at < 32-34 weeks to reduce the likelihood of cerebral palsy in the child. MAGnesium sulphate for fetal neuroprotection to prevent Cerebral Palsy (MAG-CP) was a multifaceted knowledge translation (KT) strategy for this practice. METHODS: The KT strategy included national clinical practice guidelines, a national online e-learning module and, at MAG-CP sites, educational rounds, focus group discussions and surveys of barriers and facilitators. Participating sites contributed data on pregnancies with threatened very preterm birth. In an interrupted time-series study design, MgSO4 use for fetal neuroprotection (NP) was tracked prior to (Aug 2005-May 2011) and during (Jun 2011-Sept 2015) the KT intervention. Effectiveness of the strategy was measured by optimal MgSO4 use (i.e. administration when and only when indicated) over time, evaluated by a segmented generalised estimating equations logistic regression (p < 0.05 significant). Secondary outcomes included maternal effects and, using the Canadian Neonatal Network (CNN) database, national trends in MgSO4 use for fetal NP and associated neonatal resuscitation. With an anticipated recruitment of 3752 mothers over 4 years at Canadian Perinatal Network sites, we anticipated > 95% power to detect an increase in optimal MgSO4 use for fetal NP from < 5 to 80% (2-sided, alpha 0.05) and at least 80% power to detect any increases observed in maternal side effects from RCTs. RESULTS: Seven thousand eight hundred eighty-eight women with imminent preterm birth were eligible for MgSO4 for fetal NP: 4745 pre-KT (18 centres) and 3143 during KT (11 centres). The KT intervention was associated with an 84% increase in the odds of optimal use (OR 1.00 to 1.84, p < 0.001), a reduction in the odds of underuse (OR 1.00 to 0.47, p < 0.001) and an increase in suboptimal use (too early or at ≥ 32 weeks; OR 1.18 to 2.18, p < 0.001) of MgSO4 for fetal NP. Maternal hypotension was uncommon (7/1512, 0.5%). Nationally, intensive neonatal resuscitation decreased (p = 0.024) despite rising MgSO4 use for fetal NP (p < 0.001). CONCLUSION: Multifaceted KT was associated with significant increases in use of MgSO4 for fetal NP, with neither important maternal nor neonatal risks.

The Community-Level Interventions for Pre-eclampsia (CLIP) cluster randomised trials in Mozambique, Pakistan, and India: an individual participant-level meta-analysis

To overcome the three delays in triage, transport and treatment that underlie adverse pregnancy outcomes, we aimed to reduce all-cause adverse outcomes with community-level interventions targeting women with pregnancy hypertension in three low-income countries. Methods: In this individual participant-level meta-analysis, we de-identified and pooled data from the Community-Level Interventions for Pre-eclampsia (CLIP) cluster randomised controlled trials in Mozambique, Pakistan, and India, which were run in 2014-17. Consenting pregnant women, aged 12-49 years, were recruited in their homes. Clusters, defined by local administrative units, were randomly assigned (1:1) to intervention or control groups. The control groups continued local standard of care. The intervention comprised community engagement and existing community health worker-led mobile health-supported early detection, initial treatment, and hospital referral of women with hypertension. For this meta-analysis, as for the original studies, the primary outcome was a composite of maternal or perinatal outcome (either maternal, fetal, or neonatal death, or severe morbidity for the mother or baby), assessed by unmasked trial surveillance personnel. For this analysis, we included all consenting participants who were followed up with completed pregnancies at trial end. We analysed the outcome data with multilevel modelling and present data with the summary statistic of adjusted odds ratios (ORs) with 95% CIs (fixed effects for maternal age, parity, maternal education, and random effects for country and cluster). This meta-analysis is registered with PROSPERO, CRD42018102564. Findings: Overall, 44 clusters (69 330 pregnant women) were randomly assigned to intervention (22 clusters [36 008 pregnancies]) or control (22 clusters [33 322 pregnancies]) groups. 32 290 (89·7%) pregnancies in the intervention group and 29 698 (89·1%) in the control group were followed up successfully. Median maternal age of included women was 26 years (IQR 22-30). In the intervention clusters, 6990 group and 16 691 home-based community engagement sessions and 138 347 community health worker-led visits to 20 819 (57·8%) of 36 008 women (of whom 11 095 [53·3%] had a visit every 4 weeks) occurred. Blood pressure and dipstick proteinuria were assessed per protocol. Few women were eligible for methyldopa for severe hypertension (181 [1%] of 20 819) or intramuscular magnesium sulfate for pre-eclampsia (198 [1%]), of whom most accepted treatment (162 [89·5%] of 181 for severe hypertension and 133 [67·2%] of 198 for pre-eclampsia). 1255 (6%) were referred to a comprehensive emergency obstetric care facility, of whom 864 (82%) accepted the referral. The primary outcome was similar in the intervention (7871 [24%] of 32 290 pregnancies) and control clusters (6516 [22%] of 29 698; adjusted OR 1·17, 95% CI 0·90-1·51; p=0·24). No intervention-related serious adverse events occurred, and few adverse effects occurred after in-community...