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Chlorhexidine vaginal and infant wipes to reduce perinatal mortality and morbidity: a randomized controlled trial.

ABSTRACT: To estimate the effects of chlorhexidine vaginal and baby wipes on fetal and neonatal mortality, respectively, and infection-related morbidity.We performed a placebo-controlled, randomized trial of chlorhexidine vaginal and neonatal wipes to reduce neonatal sepsis and mortality in three hospitals in Pakistan. The primary study outcome was a composite of neonatal sepsis or 7-day perinatal mortality.From 2005 to 2008, 5,008 laboring women and their neonates were randomly assigned to receive either chlorhexidine wipes (n=2,505) or wipes with a saline placebo (n=2,503). The primary outcome was similar in the chlorhexidine and control groups (3.1% compared with 3.4%; relative risk 0.91, 95% confidence interval 0.67-1.24) as was the composite rate of neonatal sepsis or 28-day perinatal mortality (3.8% compared with 3.9%, relative risk 0.96, 95% confidence interval 0.73-1.27). At day 7, the chlorhexidine group had a lower rate of neonatal skin infection (3.3% compared with 8.2%, P<.001). With the exception of less frequent 7-day hospitalization in the chlorhexidine group, there were no significant differences in maternal outcomes between the groups.Using maternal chlorhexidine vaginal wipes during labor and neonatal chlorhexidine wipes does not reduce maternal and perinatal mortality or neonatal sepsis. The finding of reduced superficial skin infections on day 7 without change in sepsis or mortality suggests that this difference, although statistically significant, may not be of major importance.I.

SUBMITTER: Saleem S

PROVIDER: S-EPMC3893917 | biostudies-literature | 2010 Jun

REPOSITORIES: biostudies-literature

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Chlorhexidine vaginal and infant wipes to reduce perinatal mortality and morbidity: a randomized controlled trial.

Saleem Sarah S Rouse Dwight J DJ McClure Elizabeth M EM Zaidi Anita A Reza Tahira T Yahya Y Y Memon I A IA Khan N H NH Memon G G Soomro N N Pasha Omrana O Wright Linda L LL Moore Janet J Goldenberg Robert L RL

Obstetrics and gynecology 20100601 6

<h4>Objective</h4>To estimate the effects of chlorhexidine vaginal and baby wipes on fetal and neonatal mortality, respectively, and infection-related morbidity.<h4>Methods</h4>We performed a placebo-controlled, randomized trial of chlorhexidine vaginal and neonatal wipes to reduce neonatal sepsis and mortality in three hospitals in Pakistan. The primary study outcome was a composite of neonatal sepsis or 7-day perinatal mortality.<h4>Results</h4>From 2005 to 2008, 5,008 laboring women and their ...[more]

PMID: 20502294

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Project description:BackgroundNigeria presently has the second highest absolute number of maternal deaths and perinatal deaths (stillbirth and neonatal deaths) in the world. The country accounts for up to 14% of global maternal deaths and is second only to India in the number of women who die during childbirth. Although all parts of the country are worsened by these staggering statistics, several lines of evidence show that most maternal, and perinatal deaths occur in the north-east and north-west geo-political zones where women have limited access to evidence-based maternal and neonatal health services. The proposed project intends to identify the demand and supply factors that prevent women from using PHCs for maternal and early new-born care in Nigeria, and to test innovative and community relevant interventions for improving women's access to PHC services, and thus, ultimately, to prevent maternal and perinatal deaths.MethodsAn open-labelled, randomized controlled trial will is carried out in two local government areas selected based on three criteria (i) maternal mortality rates (ii) PHC utilization rates and (iii) and geographic localization. The study will be conducted over 54-months in six communities, with PHCs in six communities of similar status serving as control sites. Surveys about quality of care and maternal health services utilization will be carried out at baseline, at midterm and at end of the project to test the effectiveness of the intervention, alongside conventional epidemiological measures of maternal and perinatal mortality. Ethical approval for the study has been granted (reference no. NHREC/01/01/2007). The findings will be published in compliance with reporting guidelines for randomized controlled trials.DiscussionThe current Federal Government in Nigeria has identified PHC as its main strategy for increasing access to health in Nigeria. However, despite numerous efforts, there are persisting concerns that there is currently no scientific evidence on which to base the improvement of PHCs. The results of this study will identify barriers in the use of PHCs and will provide scientific evidence for effective and innovative interventions for improving PHCs that can be rolled out throughout the country.Trial registrationClinical Trials.gov NCT02643953.

Project description:Overweight and obesity during pregnancy are risk factors for a large number of perinatal complications, both for the mother and the infant. Risk stratification and early interventions are therefore highly clinically important to minimize future complications. Currently, body mass index (BMI) in early pregnancy is used for risk stratification of pregnant women, but a disadvantage of BMI is that it does not distinguish muscle from fat tissue and central from peripheral adiposity. Maternal fat distribution is suggested to be a better predictor than BMI of obesity-related adverse pregnancy outcomes, with central adiposity posing a greater risk than peripheral subcutaneous fat. With this study, we aimed to systematically review the evidence of what impact maternal central adiposity in early to mid-pregnancy or at most 365 days prior to conception has on infant anthropometry and perinatal morbidity. The databases PubMed/MEDLINE, Web of Science Core Collection, CINAHL, SCOPUS, Clinical Trials, and Open Grey were searched from inception until November 2019. Eligible studies assessed the association between maternal central adiposity, in early to mid-pregnancy or at most 365 days prior to conception, and any of the following infant outcomes: preterm delivery (< 37 weeks of gestation), birthweight, macrosomia, large for gestational age, congenital malformations, hypoglycemia, hyperbilirubinemia, care at neonatal intensive care unit, and death. Two authors independently screened titles and abstracts, read the included full-text studies, and extracted data. The Newcastle-Ottawa Quality Assessment Scale for cohort studies was used to evaluate the quality of and risk of bias in the studies. A total of 720 records were identified, 20 full-text studies assessed for eligibility, and 10 cohort studies included in the review. The results suggest that central adiposity in early to mid-pregnancy or at most 365 days prior to conception may contribute to increased birthweight and increased likelihood of delivery by cesarean section. There is also some evidence of associations between central adiposity and preterm delivery (< 37 weeks of gestation), and admission to neonatal intensive care unit. A meta-analysis was not possible to perform due to substantial heterogeneity among the included studies regarding the exposure, outcome, and statistical methods used. Hence, central adiposity in early to mid-pregnancy or at most 365 days prior to conception could be a possible risk marker in addition to BMI for risk stratification of pregnant women. However, since the topic is only scarcely researched, and the results not unanimous, more studies are needed to further clarify the associations between maternal central adiposity and adverse neonatal complications, before any altered recommendations of guidelines could be made. To enable a future meta-analysis, studies using similar methods for central adiposity assessment,and similar outcome measures, are required.

Project description:BackgroundA medication review can be defined as a structured evaluation of a patient's medication conducted by healthcare professionals with the aim of optimising medication use and improving health outcomes. Optimising medication therapy though medication reviews may benefit hospitalised patients.ObjectivesWe examined the effects of medication review interventions in hospitalised adult patients compared to standard care or to other types of medication reviews on all-cause mortality, hospital readmissions, emergency department contacts and health-related quality of life.Search methodsIn this Cochrane Review update, we searched for new published and unpublished trials using the following electronic databases from 1 January 2014 to 17 January 2022 without language restrictions: the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, the Cumulative Index to Nursing and Allied Health Literature (CINAHL), ClinicalTrials.gov and the WHO International Clinical Trials Registry Platform (ICTRP). To identify additional trials, we searched the reference lists of included trials and other publications by lead trial authors, and contacted experts.Selection criteriaWe included randomised trials of medication reviews delivered by healthcare professionals for hospitalised adult patients. We excluded trials including outpatients and paediatric patients.Data collection and analysisTwo review authors independently selected trials, extracted data and assessed risk of bias. We contacted trial authors for data clarification and relevant unpublished data. We calculated risk ratios (RRs) for dichotomous data and mean differences (MDs) or standardised mean differences (SMDs) for continuous data (with 95% confidence intervals (CIs)). We used the GRADE (Grades of Recommendation, Assessment, Development and Evaluation) approach to assess the overall certainty of the evidence.Main resultsIn this updated review, we included a total of 25 trials (15,076 participants), of which 15 were new trials (11,501 participants). Follow-up ranged from 1 to 20 months. We found that medication reviews in hospitalised adults may have little to no effect on mortality (RR 0.96, 95% CI 0.87 to 1.05; 18 trials, 10,108 participants; low-certainty evidence); likely reduce hospital readmissions (RR 0.93, 95% CI 0.89 to 0.98; 17 trials, 9561 participants; moderate-certainty evidence); may reduce emergency department contacts (RR 0.84, 95% CI 0.68 to 1.03; 8 trials, 3527 participants; low-certainty evidence) and have very uncertain effects on health-related quality of life (SMD 0.10, 95% CI -0.10 to 0.30; 4 trials, 392 participants; very low-certainty evidence).Authors' conclusionsMedication reviews in hospitalised adult patients likely reduce hospital readmissions and may reduce emergency department contacts. The evidence suggests that mediation reviews may have little to no effect on mortality, while the effect on health-related quality of life is very uncertain. Almost all trials included elderly polypharmacy patients, which limits the generalisability of the results beyond this population.

Project description:BackgroundThe early life gut microbiota are an important regulator of the biological pathways contributing toward the pathogenesis of noncommunicable disease. It is unclear whether improvements to perinatal diet quality could alter the infant gut microbiota.ObjectiveThe aim of this study is to assess the efficacy of a perinatal educational dietary intervention in influencing gut microbiota in mothers and infants 4 weeks after birth.MethodsThe Healthy Parents, Healthy Kids randomized controlled trial aimed to recruit 90 pregnant women from Melbourne, Victoria, Australia. At week 26 of gestation, women were randomized to receive dietary advice from their doctor (n=45), or additionally receive a dietary intervention (n=45). The intervention included an educational workshop and 2 support calls aiming to align participants' diets with the Australian Dietary Guidelines and increase intakes of prebiotic and probiotic foods. The educational design focused on active learning and self-assessment. Behavior change techniques were used to support dietary adherence, and the target behavior was eating for the gut microbiota. Exclusion criteria were age under 18 years, diagnosed mental illnesses, obesity, diabetes mellitus, diagnosed bowel conditions, exclusion diets, illicit drug use, antibiotic use, prebiotic or probiotic supplementation, and those lacking dietary autonomy. The primary outcome measure is a between-group difference in alpha diversity in infant stool collected 4 weeks after birth. Secondary outcomes include evaluating the efficacy of the intervention in influencing infant and maternal stool microbial composition and short chain fatty acid concentrations, epigenetic profile, and markers of inflammation and stress, as well as changes in maternal dietary intake and well-being. The study and intervention feasibility and acceptance will also be evaluated as secondary outcomes.ResultsThe study results are yet to be written. The first participant was enrolled on July 28, 2016, and the final follow-up assessment was completed on October 11, 2017.ConclusionsData from this study will provide new insights regarding the ability of interventions targeting the perinatal diet to alter the maternal and infant gut microbiota. If this intervention is proven, our findings will support larger studies aiming to guide the assembly of gut microbiota in early life.Trial registrationAustralian Clinical Trials Registration Number ACTRN12616000936426; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=370939.International registered report identifier (irrid)DERR1-10.2196/14771.

Dataset Information

Chlorhexidine vaginal and infant wipes to reduce perinatal mortality and morbidity: a randomized controlled trial.

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Chlorhexidine vaginal and infant wipes to reduce perinatal mortality and morbidity: a randomized controlled trial.

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