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The influence of timing of Maternal administration of Antibiotics during cesarean section on the intestinal Microbial colonization in Infants (MAMI-trial): study protocol for a randomised controlled trial.

ABSTRACT: BACKGROUND:A disturbance in the early colonisation of the gut by microorganisms is associated with an aberrant innate immune system and a variety of clinical conditions later in life. Several factors are considered to influence this initial colonisation, including maternally administered antibiotics during pregnancy and delivery. Recent revisions to international obstetric guidelines have resulted in the exposure of all infants born by caesarean section (CS) to broad-spectrum antibiotics perinatally. To date, the consequences of these new guidelines on neonatal gut colonisation and the associated short- and long-term health implications have not yet been addressed. The aim of this study is to investigate the influence of the timing of antibiotic administration during CS to the mother on the course of neonatal intestinal colonisation up to 2 years of age. METHODS/DESIGN:This single-centre randomised controlled trial will recruit 40 women scheduled for an elective CS. The subjects will be randomised to receive 1500 mg of cefuroxime intravenously either prior to the skin incision (n = 20) or after clamping of the umbilical cord (n = 20). Levels of cefuroxime in cord blood will be determined for exposed neonates. Faecal samples from the children will be collected on days 1, 7 and 28 days and at 2 years old and analysed by 16S sequencing. Shannon-diversity indices, absolute and relative abundances, and unsupervised and supervised classification methods will be used to evaluate the effect of the timing of intrapartum cefuroxime administration on the composition of the microbiota. The outcomes for both study groups will be compared to the intestinal microbiota of vaginally born infants (n = 20). To detect possible effects on health state, a questionnaire on health-related issues will be taken at the age of 2 years. DISCUSSION:In the proposed study, changes in the intestinal microbiota of 40 children born by CS will be followed until the age of 2 years. Research on this topic is necessary since significant effects relating to the timing of antibiotic administration on microbial colonisation may conflict with the current guidelines, as this may have health consequences later in life. TRIAL REGISTRATION:Netherlands Clinical Trial Registry, NTR6000 . Retrospectively registered on 25 July 2016.

SUBMITTER: Dierikx TH

PROVIDER: S-EPMC6683546 | biostudies-other | 2019 Aug

REPOSITORIES: biostudies-other

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The influence of timing of Maternal administration of Antibiotics during cesarean section on the intestinal Microbial colonization in Infants (MAMI-trial): study protocol for a randomised controlled trial.

Dierikx Thomas H TH Berkhout Daniel J C DJC Visser Laura L Benninga Marc A MA Roeselers Guus G de Boer Nanne K H NKH de Vries Johanna I P JIP de Meij Tim G J TGJ

Trials 20190805 1

<h4>Background</h4>A disturbance in the early colonisation of the gut by microorganisms is associated with an aberrant innate immune system and a variety of clinical conditions later in life. Several factors are considered to influence this initial colonisation, including maternally administered antibiotics during pregnancy and delivery. Recent revisions to international obstetric guidelines have resulted in the exposure of all infants born by caesarean section (CS) to broad-spectrum antibiotics ...[more]

PMID: 31382981

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Project description:BackgroundProphylactic antibiotics reduce infectious morbidity from caesarean section. The timing of their administration, however, is a matter of controversy.ObjectivesTo examine maternal and neonatal infectious morbidity in women receiving preoperative prophylaxis compared with those receiving intraoperative administration.Search strategyMedline, Embase, Current Controlled Trials and Cochrane Central were searched from their inception dates to December 2011.Selection criteriaRandomised controlled trials of a single dose of any antibiotic comparing preoperative with intraoperative administration were selected.Data collection and analysisTrial characteristics, outcomes and quality measures, based on the Cochrane tool for risk of bias, were independently extracted. The random effect model of DerSimonian and Laird to estimate relative risks (RRs) for maternal and neonatal outcomes was used.Main resultsSix trials met the inclusion criteria, reporting on 2313 women and 2345 newborns. Preoperative administration was associated with a significant 41% reduction in the rate of endometritis compared with intraoperative administration (RR 0.59; 95% confidence interval [95% CI] 0.37-0.94; I2 0%). In the preoperative group, there were nonsignificant reductions in the rates of wound infection (RR 0.71; 95% CI 0.44-1.14; I2 0%), maternal febrile morbidity (RR 0.94; 95% CI 0.46-1.95; I2 0%), neonatal sepsis (RR 0.81; 95% CI 0.47-1.41; I2 0%), neonatal septic work-up (RR 0.93; 95% CI 0.71-1.21; I2 0%) and neonatal intensive-care unit admission (RR 0.92; 95% CI 0.65-1.28; I2 0%). There were nonsignificant increases in the rates of maternal pyelonephritis (RR 1.09; 95% CI 0.49-2.43; I2 0%) and neonatal pneumonia (RR 3.36; 95% CI 0.55-20.47; I2 0%).ConclusionsCompared with intraoperative administration, preoperative antibiotics significantly reduce the rate of endometritis. The lack of neonatal adverse effects should be cautiously interpreted given the limited power of the trials to detect such effects.

Project description:BackgroundThere is no consensus on the best timing for prophylactic oxytocin administration during cesarean section (CS) to prevent post-partum hemorrhage (PPH).ObjectivesAssess the effects of administrating prophylactic oxytocin at different times during CS.MethodsWe searched nine databases to identify relevant randomized controlled trials (RCT). We pooled results and calculated average risk ratios (RR), mean differences (MD), and 95% confidence intervals (CI). We used GRADE to assess the overall evidence certainty.ResultsWe screened 13,389 references and included four trials. We found no statistically significant differences between oxytocin given before versus after fetal delivery on PPH (RR 0.60, 95%CI 0.15-2.47; 1 RCT, N = 300) or nausea/vomiting (RR 1.21, 95%CI 0.69-2.13; 1 RCT, N = 300). There was a significant reduction in the need for additional uterotonics when oxytocin was given immediately before uterine incision versus after fetal delivery (RR 0.37, 95%CI 0.18-0.73; I2 = 0%; 2 RCTs; N = 301). Oxytocin given before fetal delivery significantly reduced intra-operative blood loss (MD -146.77mL, 95%CI -168.10 to -125.43; I2 = 0%; 3 RCTs, N = 601) but did not change the incidence of blood transfusion (RR 0.50, 95%CI 0.13-1.95; I2 = 0%; 2 RCTs, N = 301) or hysterectomy (RR 3.00; 95%CI 0.12-72.77; I2 = 0%; 2 RCTs, N = 301). One trial (N = 100) compared prophylactic oxytocin before versus after placental separation and found no significant differences on PPH, additional uterotonics, or nausea/vomiting.ConclusionsIn women having pre-labor CS, there is limited evidence indicating no significant differences between prophylactic oxytocin given before versus after fetal delivery on PPH, nausea/vomiting, blood transfusion, or hysterectomy. Earlier oxytocin administration may reduce the volume of blood loss and need for additional uterotonics. There is very limited evidence suggesting no significant differences between prophylactic oxytocin given before versus after placental separation on PPH, need for additional uterotonic, or nausea/vomiting. The overall certainty of the evidence was mostly low or very low due to imprecision. Protocol: CRD42020186797.

Project description:BACKGROUND:Anticoagulant therapy during pregnancy is widely used due to the increasing awareness of maternal hypercoagulability. Few studies have reported the use of minimally invasive spinal anesthesia in these parturients. The objective of this study was to evaluate the safety and feasibility of minimally invasive spinal anesthesia in parturients with anticoagulation therapy undergoing cesarean section. METHODS:This was a randomized, controlled study conducted in 239 parturients using anticoagulants and undergoing selective cesarean section. 37 parturients withdrew, and finally parturients received spinal anesthesia using 27gauge pen type fine spinal needles (experimental group, n?=?110) and 22gauge traditional spinal needles (control group, n?=?92). The primary efficacy outcomes included low back pain (LBP) and postdural puncture headache (PDPH) after delivery. Secondary efficacy outcomes included visual analogue scale during subarachnoid puncture (VASdural), difference between visual analogue scale (VAS) during peripheral venipuncture and VASdural (?VAS), VAS of back puncture point 24, 48 and 72?h after operation (VASdural-24?h, VASdural-48?h and VASdural-72?h, respectively), maternal satisfaction and hospitalization stay. RESULTS:No parturient had PDPH and was suspected with spinal or intracranial haematoma in two groups. There was no significant difference in VASlbp-24?h, VASlbp-48?h and VASlbp-72?h (P?=?0.056; P?=?0.813; P?=?0.189, respectively) between two groups. In experimental group, VASdural (P?=?0.017), ?VAS (P?=?0.001) and VASdural-24?h (P?<?0.0001) were lower, whereas maternal satisfaction was higher (P?=?0.046). There was no significant difference in VASdural-48?h, VASdural-72?h, urination function, strength recovery and hospitalization stay (P?=?0.069; P?=?0.667; P?=?0.105; P?=?0.133; P?=?0.754, respectively) between the two groups. CONCLUSIONS:Minimally invasive spinal anesthesia provided lower VASdural, VASdrual-24?h and a higher maternal satisfaction. Hence, it is considered as a safe, reliable and reasonable option for cesarean section parturients during maternal anticoagulation therapy with normal platelet count and coagulation time. TRIAL REGISTRATION:This study was registered at www.ClinicalTrials.gov at November 11th, 2016 ( NCT02987192 ).

Project description:The maternal vaginal microbiome is an important source for infant gut microbiome development. However, infants delivered by Cesarean section (CS) do not contact the maternal vaginal microbiome and this delivery method may perturb the early establishment and development of the gut microbiome. The aim of this study was to investigate the early gut microbiota of Korean newborns receiving the same postpartum care services for two weeks after birth by delivery mode using fecal samples collected at days 3, 7, and 14. Early gut microbiota development patterns were examined using 16S rRNA gene-based sequencing from 132 infants either born vaginally (VD, n = 64) or via Cesarean section (CS, n = 68). VD-born neonates showed increased alpha diversity in infant fecal samples collated at days 7 and 14 compared to those from day 3, while those of CS infants did not differ (p < 0.015). Bacterial structures of infants from both groups separated at day 7 (p < 0.001) and day 14 (p < 0.01). The bacterial structure of VD infants gradually changed over time (day 3 vs. day 7, p < 0.012; day 3 vs. day 14, p < 0.001). Day 14 samples of CS infants differed from day 3 and 7 samples (day 3 vs. day 14, p < 0.001). VD infant relative abundance of Bifidobacterium (days 7, 14), Bacteroides (days 7, 14), and Lachnospiraceae (day 7) significantly increased compared to CS infants, with a lower abundance of Enterobacteriaceae (found in all periods of the CS group) (LDA > 3.0). Relative abundances of Bifidobacterium, Lactobacillus, and Staphylococcus were significantly increased in both VD and CS groups at day 14 (LDA > 3.0). Predicted functional analysis showed that VD infants had overrepresented starch/sucrose, amino acid and nucleotide metabolism in gut microbiota with depleted lipopolysaccharide biosynthesis until day 14 compared to CS infants. This study confirmed that delivery mode is the major determinant of neonatal intestinal microbiome establishment and provides a profile of microbiota perturbations in CS infants. Our findings provide preliminary insight for establishing recovery methods to supply the specific microbes missing in CS infants.

Project description:BackgroundPregnant women who request a cesarean section in the absence of obstetric indication have become a highly debated issue in academic as well as popular literature. In order to find adequate, targeted treatment and preventive strategies, we need a better understanding of this phenomenon. The aim of this study is to provide a qualitative exploration of maternal requests for a planned cesarean section in Norway, in the absence of obstetric indications.MethodsA descriptive qualitative study was conducted consisting of 17 semi-structured, in-depth interviews with women requesting cesarean section and six focus group discussions with 20 caregivers (nine midwives, 11 obstetricians) working at a university hospital in Norway. Data were analyzed with Systematic Text Condensation, a method for thematic cross-case analysis.ResultsFear of birth emerged most commonly as a result of a previous traumatic birth experience that prompted a preference for a planned cesarean to avoid a repetition of the trauma. For some women in our study, postnatal care and the puerperal period were their crucial past experiences, and giving birth by planned cesarean was seen as a way to ensure mental rather than physical capability to care for the expected child after birth. Others were under the impression of being at high risk for an emergency C-section, and requesting a planned one was based on their perceived risk. Such perceptions included having a narrow pelvis, hereditary factors or previous birth outcomes. Some primiparas requested a planned cesarean based on a deep-seated fear since their early teens, accompanied by alienation towards the idea of giving birth. Some obstetricians participating in our study also experienced requests that lacked what they regarded as any well-grounded reason or significant fear.ConclusionsBehind a maternal request for a planned cesarean section are various rationales and life experiences needing carefully targeted attention and health care. Previous births are an important driver; thus, maternally requested cesareans should be regarded partly as an iatrogenic problem.

Project description:BackgroundBirth by caesarean section (CS) is associated with aberrant gut microbiome development and greater disease susceptibility later in life. We investigated whether oral administration of maternal vaginal microbiota to infants born by CS could restore their gut microbiome development in a pilot single-blinded, randomised placebo-controlled trial (Australian New Zealand Clinical Trials Registry, ACTRN12618000339257).MethodsPregnant women scheduled for a CS underwent comprehensive antenatal pathogen screening. At birth, healthy neonates were randomised to receive a 3 ml solution of either maternal vaginal microbes (CS-seeded, n = 12) or sterile water (CS-placebo, n = 13). Vaginally-born neonates were used as the reference control (VB, n = 22). Clinical assessments occurred within the first 2 h of birth, and at 1 month and 3 months of age. Infant stool samples and maternal vaginal extracts from CS women underwent shotgun metagenomic sequencing. The primary outcome was gut microbiome composition at 1 month of age. Secondary outcomes included maternal strain engraftment, functional potential of the gut microbiome, anthropometry, body composition, and adverse events.FindingsDespite the presence of viable microbial cells within transplant solutions, there were no observed differences in gut microbiome composition or functional potential between CS-seeded and CS-placebo infants at 1 month or 3 months of age. Both CS groups displayed the characteristic signature of low Bacteroides abundance, which contributed to a number of biosynthesis pathways being underrepresented when compared with VB microbiomes. Maternal vaginal strain engraftment was rare. Vaginal seeding had no observed effects on anthropometry or body composition. There were no serious adverse events associated with treatment.InterpretationOur pilot findings question the value of vaginal seeding given that oral administration of maternal vaginal microbiota did not alter early gut microbiome development in CS-born infants. The limited colonisation of maternal vaginal strains suggest that other maternal sources, such as the perianal area, may play a larger role in seeding the neonatal gut microbiome.FundingHealth Research Council of New Zealand, A Better Start - National Science Challenge.

Project description:Children delivered by elective, prelabor Cesarean section (C-section) are not exposed to the birth canal microbiota and, in relation to vaginally delivered children, show altered microbiota development. Perturbed microbial colonization during critical early-life windows of development alters metabolic and immune programming and is associated with an increased risk of immune and metabolic diseases. In nonrandomized studies, vaginal seeding of C-section-born neonates partially restores their microbiota colonization to that of their vaginally delivered counterparts, but without randomization, confounding factors cannot be excluded. In a double-blind, randomized, placebo-controlled trial, we determined the effect of vaginal seeding versus placebo seeding (control arm) on the skin and stool microbiota of elective, prelabor C-section-born neonates (n = 20) at 1 day and 1 month after birth. We also examined whether there were between-arm differences in engraftment of maternal microbes in the neonatal microbiota. In relation to the control arm, vaginal seeding increased mother-to-neonate microbiota transmission and caused compositional changes and a reduction in alpha diversity (Shannon Index) of the skin and stool microbiota. The neonatal skin and stool microbiota alpha diversity when maternal vaginal microbiota is provided is intriguing and highlights the need of larger randomized studies to determine the ecological mechanisms and effects of vaginal seeding on clinical outcomes. IMPORTANCE Children delivered by elective C-section are not exposed to the birth canal and show altered microbiota development. Impairing microbial colonization during early life alters metabolic and immune programming and is associated with an increased risk of immune and metabolic diseases. In a double-blind, randomized, placebo-controlled trial, we determined the effect of vaginal seeding on the skin and stool microbiota of elective C-section born neonates and found that vaginal seeding increased mother-to-neonate microbiota transmission and caused compositional changes and a reduction in the skin and stool microbiota diversity. The reduction of neonatal skin and stool microbiota diversity when maternal vaginal microbiota is provided is intriguing and highlights the need of larger randomized studies to determine the ecological mechanisms and effects of vaginal seeding on clinical outcomes.

Dataset Information

The influence of timing of Maternal administration of Antibiotics during cesarean section on the intestinal Microbial colonization in Infants (MAMI-trial): study protocol for a randomised controlled trial.

Publications

The influence of timing of Maternal administration of Antibiotics during cesarean section on the intestinal Microbial colonization in Infants (MAMI-trial): study protocol for a randomised controlled trial.

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