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Timing of Antibiotic Prophylaxis in Elective Caesarean Delivery: A Multi-Center Randomized Controlled Trial and Meta-Analysis.

ABSTRACT: To compare the effectiveness of antibiotic prophylaxis before skin incision with that after umbilical cord clamping in elective caesarean delivery.We conducted a randomized open-label controlled trial with two parallel arms at three hospitals in western China. Participants meeting the inclusion criteria received antibiotics 30-60 minutes before skin incision while others received antibiotics after umbilical cords clamping. For the meta-analysis, studies were identified from the database of PUBMED, Cochrane Library and EMbase and assessed using the Cochrane risk of bias tool.Four hundred and ten patients were randomized to receive antibiotics before skin incision (n = 205) or after umbilical cords clamping (n = 205). There was no difference in the incidence of postpartum endometritis (RR = 0.34, 95% CI 0.04 to 3.24), wound infection (RR = 3.06, 95% CI 0.13 to 74.69) and total puerperal morbidity (RR = 1.02, 95% CI 0.47 to 2.22). No increase in the incidence of neonatal sepsis (RR = 0.34, 95% CI 0.04 to 3.24), septic workup (RR = 0.41, 95% CI 0.08 to 2.07), or intermediate NICU admission (RR = 0.73, 95% CI 0.24 to 2.26) was observed. The meta-analysis involving nine RCTs showed that no statistically significant difference was found in terms of the risk of postpartum endometritis (RR = 0.73, 95% CI 0.39, 1.36), wound infection (RR = 0.80, 95%CI 0.55, 1.17), or puerperal morbidity (RR = 0.89, 95% CI 0.70, 1.13). No increase in the incidence of neonatal sepsis (RR = 0.65, 95% CI 0.35 to 1.20), septic workup (RR = 0.88, 95% CI 0.50 to 1.54), or intermediate NICU admission (RR = 0.91, 95% CI 0.70 to 1.18) was observed.For elective caesarean delivery, the effects of antibiotic prophylaxis before skin incision and after umbilical cord clamping were equal. Both antibiotic prophylaxis before skin incision and that after umbilical cord clamping were recommended for elective caesarean delivery. The outcome of further studies should address both maternal and neonatal infectious morbidity as well as long-term neonatal follow up.Chinese Clinical Trial Registry ChiCTR-TRC-11001853.

SUBMITTER: Zhang C

PROVIDER: S-EPMC4492889 | biostudies-literature | 2015

REPOSITORIES: biostudies-literature

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Timing of Antibiotic Prophylaxis in Elective Caesarean Delivery: A Multi-Center Randomized Controlled Trial and Meta-Analysis.

Zhang Chuan C Zhang Lingli L Liu Xinghui X Zhang Li L Zeng Zhiyou Z Li Lin L Liu Guanjian G Jiang Hong H

PloS one 20150706 7

<h4>Objective</h4>To compare the effectiveness of antibiotic prophylaxis before skin incision with that after umbilical cord clamping in elective caesarean delivery.<h4>Methods</h4>We conducted a randomized open-label controlled trial with two parallel arms at three hospitals in western China. Participants meeting the inclusion criteria received antibiotics 30-60 minutes before skin incision while others received antibiotics after umbilical cords clamping. For the meta-analysis, studies were ide ...[more]

PMID: 26148063

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Project description:ObjectiveTo assess the effects on maternal infectious morbidity and neonatal outcomes of the timing of antibiotic prophylaxis in women undergoing caesarean section. A recent National Institute for Health and Clinical Excellence (NICE) guideline reported that antibiotic administration before skin incision reduces the risk of maternal infection; this recommendation was based on a meta-analysis, however one including trials that were not double blind and not including a trial published recently.DesignSystematic review and meta-analysis.Data sourcesSearches of PubMed and EMBASE and reference lists of the retrieved articles.Inclusion criteriaRandomised double-blind controlled trials comparing the administration of antibiotics before skin incision with administration after cord clamping.Data extraction and analysisData on maternal total infectious morbidity, endometritis and wound infection, as well as neonatal intensive care unit admission, neonatal infection and neonatal sepsis were extracted and combined using random effects meta-analysis.ResultsFive studies reporting on 1777 parturients were included in our systematic review. The relative risk (RR) for maternal total infectious morbidity for antibiotic administration before incision compared with antibiotic administration after cord clamping was 0.64 (95% CI 0.36 to 1.15). Likewise, there was no difference in the risk of wound infection (RR 0.72, 95% CI 0.41 to 1.27). Parturients receiving the antibiotic preoperatively had a significantly reduced risk of endometritis (RR 0.48, 95% CI 0.27 to 0.87; number needed to treat 41, 95% CI 23 to 165). Analyses of the neonatal outcome parameters revealed no differences between the regimens of antibiotic administration, but were based on few studies.ConclusionsIn contrast to a recent NICE guideline, we did not find a reduction in total infectious morbidity with antibiotic administration before skin incision; we confirmed a reduction in the risk of endometritis and a lack of effect on the risk for wound infection.

Project description:BackgroundThe OptiBIRTH study incorporates a multicentre cluster randomised trial in 15 hospital sites across three European countries. The trial was designed to test a complex intervention aimed at improving vaginal birth after caesarean section (VBAC) rates through increasing women's involvement in their care. Prior to developing a robust standardised model to conduct the health economic analysis, an analysis of a hypothetical cohort was performed to estimate the costs and health effects of VBAC compared to elective repeat caesarean delivery (ERCD) for low-risk women in four European countries.MethodsA decision-analytic model was developed to estimate the costs and the health effects, measured using Quality Adjusted Life Years (QALYs), of VBAC compared with ERCD. A cost-effectiveness analysis for the period from confirmation of pregnancy to 6 weeks postpartum was performed for short-term consequences and during lifetime for long-term consequences, based on a hypothetical cohort of 100,000 pregnant women in each of four different countries; Belgium, Germany, Ireland and Italy. A societal perspective was adopted. Where possible, transition probabilities, costs and health effects were adapted from national data obtained from the respective countries. Country-specific thresholds were used to determine the cost-effectiveness of VBAC compared to ERCD. Deterministic and probabilistic sensitivity analyses were conducted to examine the uncertainty of model assumptions.ResultsWithin a 6-week time horizon, VBAC resulted in a reduction in costs, ranging from €3,334,052 (Germany) to €66,162,379 (Ireland), and gains in QALYs ranging from 6399 (Italy) to 7561 (Germany) per 100,000 women birthing in each country. Compared to ERCD, VBAC is the dominant strategy in all four countries. Applying a lifetime horizon, VBAC is dominant compared to ERCD in all countries except for Germany (probabilistic analysis, ICER: €8609/QALY). In conclusion, compared to ERCD, VBAC remains cost-effective when using a lifetime time.ConclusionsIn all four countries, VBAC was cost-effective compared to ERCD for low-risk women. This is important for health service managers, economists and policy makers concerned with maximising health benefits within limited and constrained resources.

Project description:BackgroundElective repeat caesarean delivery (ERCD) rates have been increasing worldwide, thus prompting obstetric discourse on the risks and benefits for the mother and infant. Yet, these increasing rates also have major economic implications for the health care system. Given the dearth of information on the cost-effectiveness related to mode of delivery, the aim of this paper was to perform an economic evaluation on the costs and short-term maternal health consequences associated with a trial of labour after one previous caesarean delivery compared with ERCD for low risk women in Ireland.MethodsUsing a decision analytic model, a cost-effectiveness analysis (CEA) was performed where the measure of health gain was quality-adjusted life years (QALYs) over a six-week time horizon. A review of international literature was conducted to derive representative estimates of adverse maternal health outcomes following a trial of labour after caesarean (TOLAC) and ERCD. Delivery/procedure costs derived from primary data collection and combined both "bottom-up" and "top-down" costing estimations.ResultsMaternal morbidities emerged in twice as many cases in the TOLAC group than the ERCD group. However, a TOLAC was found to be the most-effective method of delivery because it was substantially less expensive than ERCD (€ 1,835.06 versus € 4,039.87 per women, respectively), and QALYs were modestly higher (0.84 versus 0.70). Our findings were supported by probabilistic sensitivity analysis.ConclusionsClinicians need to be well informed of the benefits and risks of TOLAC among low risk women. Ideally, clinician-patient discourse would address differences in length of hospital stay and postpartum recovery time. While it is premature advocate a policy of TOLAC across maternity units, the results of the study prompt further analysis and repeat iterations, encouraging future studies to synthesis previous research and new and relevant evidence under a single comprehensive decision model.

Project description:BackgroundThe rate of caesarean sections (CS) has increased in the last decades to about 30% of births in high income countries. Many CSs are electively planned without an urgent medical reason for mother or child. An early CS though may harm the newborn. Our aim was to evaluate the gestational time point after the 37 + 0 week of gestation (WG) (after prematurity = term) of performing an elective CS with the lowest morbidity for mother and child by assessing the time course from 37 + 0 to 42+ 6 WG.MethodsWe performed a systematic literature search in MEDLINE, EMBASE, CENTRAL and CINAHL in November 2018. We included studies that compared different time points of elective CS at term no matter the reason for elective CS. Our primary outcomes were the rate of admissions to the neonatal intensive care unit (NICU), neonatal death and maternal death in early versus late term elective CS. Various binary and dose response random effects meta-analyses were performed.ResultsWe identified 35 studies including 982,749 women. Except one randomised controlled trial, all studies were cohort studies. We performed a linear time-response meta-analysis on the primary outcome NICU admission on 14 studies resulting in a decrease of the relative risk (RR) to 0.63 (95% CI 0.56, 0.71) from 37 + 0 to 39 + 6 WG. RR for neonatal death showed a decrease to 39 + (0-6) WG (RR 0.59 95% CI 0.43 to 0.83) and increase from then on (RR 2.09 95% CI 1.18 to 3.70) assuming a U-shape course and using a cubic spline model for meta-analysis of four studies. We only identified one study analyzing maternal death resulting in RR of 0.38 (95% CI 0.04 to 3.40) for 37 + 0 + 38 + 6 WG versus ≥39 + 0 WG.ConclusionOur systematic review showed that elective CS (primary and repeated) before the 39 + 0 WG lead to more NICU admissions and neonatal deaths, although death is rare and increases again after 39 + 6 WG. We did not find enough evidence on maternal outcomes. There is a need for more research, considering maternal outcomes to provide a balanced decision between neonatal and maternal health.Systematic review registrationRegistered in PROSPERO (CRD42017078231).

Dataset Information

Timing of Antibiotic Prophylaxis in Elective Caesarean Delivery: A Multi-Center Randomized Controlled Trial and Meta-Analysis.

Publications

Timing of Antibiotic Prophylaxis in Elective Caesarean Delivery: A Multi-Center Randomized Controlled Trial and Meta-Analysis.

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