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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.

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Project description:Insufficient reductions in maternal and neonatal deaths and stillbirths in the past decade are a deterrence to achieving the Sustainable Development Goal 3. The majority of deaths occur during the intrapartum and immediate postnatal period. Overcoming the knowledge-do-gap to ensure implementation of known evidence-based interventions during this period has the potential to avert at least 2.5 million deaths in mothers and their offspring annually. This paper describes a study protocol for implementing and evaluating a multi-faceted health care system intervention to strengthen the implementation of evidence-based interventions and responsive care during this crucial period. This is a cluster randomised stepped-wedge trial with a nested realist process evaluation across 16 hospitals in Benin, Malawi, Tanzania and Uganda. The ALERT intervention will include four main components: i) end-user participation through narratives of women, families and midwifery providers to ensure co-design of the intervention; ii) competency-based training; iii) quality improvement supported by data from a clinical perinatal e-registry and iv) empowerment and leadership mentoring of maternity unit leaders complemented by district based bi-annual coordination and accountability meetings. The trial's primary outcome is in-facility perinatal (stillbirths and early neonatal) mortality, in which we expect a 25% reduction. A perinatal e-registry will be implemented to monitor the trial. Our nested realist process evaluation will help to understand what works, for whom, and under which conditions. We will apply a gender lens to explore constraints to the provision of evidence-based care by health workers providing maternity services. An economic evaluation will assess the scalability and cost-effectiveness of ALERT intervention. There is evidence that each of the ALERT intervention components improves health providers' practices and has modest to moderate effects. We aim to test if the innovative packaging, including addressing specific health systems constraints in these settings, will have a synergistic effect and produce more considerable perinatal mortality reductions. Pan African Clinical Trial Registry ( www.pactr.org ): PACTR202006793783148. Registered on 17th June 2020.

Dataset Information

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

Publications

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

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