Guidelines for postoperative care in cesarean delivery: Enhanced Recovery After Surgery (ERAS) Society recommendations (part 3).

BACKGROUND: This Enhanced Recovery After Surgery Guideline for postoperative care in cesarean delivery will provide best practice, evidenced-based recommendations for postoperative care with primarily a maternal focus. OBJECTIVE: The pathway process for scheduled and unscheduled cesarean delivery for this Enhanced Recovery After Surgery cesarean delivery guideline will consider time from completion of cesarean delivery until maternal hospital discharge. STUDY DESIGN: The literature search (1966-2017) used Embase and PubMed to search medical subject headings that included "Cesarean Section," "Cesarean Delivery," "Cesarean Section Delivery," and all postoperative Enhanced Recovery After Surgery items. Study selection allowed titles and abstracts to be screened by individual reviewers to identify potentially relevant articles. Metaanalyses, systematic reviews, randomized controlled studies, nonrandomized controlled studies, reviews, and case series were considered for each individual topic. Quality assessment and data analyses evaluated the quality of evidence, and recommendations were evaluated according to the Grading of Recommendations, Assessment, Development and Evaluation system as used and described in previous Enhanced Recovery After Surgery Guidelines. RESULTS: The Enhanced Recovery After Surgery cesarean delivery guideline/pathway has created a pathway for postoperative care. Specifics include sham feeding, nausea and vomiting prevention, postoperative analgesia, nutritional care, glucose control, thromboembolism prophylaxis, early mobilization, urinary drainage, and discharge counseling. A number of elements of postoperative care of women who undergo cesarean delivery are recommended, based on the evidence. CONCLUSION: As the Enhanced Recovery After Surgery cesarean delivery pathway (elements/processes) are studied, implemented, audited, evaluated, and optimized by the maternity care teams, there will be an opportunity for focused and optimized areas of care and recommendations to be further enhanced.

Guidelines for Antenatal and Preoperative care in Cesarean Delivery: Enhanced Recovery After Surgery Society Recommendations (Part 1).

This Enhanced Recovery After Surgery (ERAS) Guideline for perioperative care in cesarean delivery will provide best practice, evidenced-based, recommendations for preoperative, intraoperative, and postoperative phases with, primarily, a maternal focus. The focused pathway process for scheduled and unscheduled cesarean delivery for this ERAS Cesarean Delivery Guideline will consider from the time from decision to operate (starting with the 30-60 minutes before skin incision) to hospital discharge. The literature search (1966-2017) used Embase and PubMed to search medical subject headings that included "Cesarean Section," "Cesarean Section," "Cesarean Section Delivery" and all pre- and intraoperative ERAS items. Study selection allowed titles and abstracts to be screened by individual reviewers to identify potentially relevant articles. Metaanalyses, systematic reviews, randomized controlled studies, nonrandomized controlled studies, reviews, and case series were considered for each individual topic. Quality assessment and data analyses that evaluated the quality of evidence and recommendations were evaluated according to the Grading of Recommendations, Assessment, Development and Evaluation system, as used and described in previous ERAS Guidelines. The ERAS Cesarean Delivery Guideline/Pathway has created a maternal focused pathway (for scheduled and unscheduled surgery starting from 30-60 minutes before skin incision to maternal discharge) with ERAS cesarean delivery consensus recommendations preoperative elements (anesthetic medications, fasting, carbohydrate supplementation, prophylactic antibiotics/skin preparation, ), intraoperative elements (anesthetic management, maternal hypothermia prevention, surgical technique, hysterotomy creation and closure, management of peritoneum, subcutaneous space, and skin closure), perioperative fluid management, and postoperative elements (chewing gum, management of nausea and vomiting, analgesia, timing of food intake, glucose management, antithrombotic prophylaxis, timing of ambulation, urinary management, and timing of maternal and neonate discharge). Limited topics for optimized care and for antenatal education and counselling and the immediate neonatal needs at delivery are discussed. Strong recommendations for element use were given for preoperative (antenatal education and counselling, use of antacids and histamine, H2 receptor antagonists, 2-hour fasting and small meal within 6 hours surgery, antimicrobial prophylaxis and skin preparation/chlorhexidine-alcohol), intraoperative (regional anesthesia, prevention of maternal hypothermia [forced warm air, warmed intravenous fluids, room temperature]), perioperative (fluid management for euvolemia and neonatal immediate care needs that include delayed cord clamping), and postoperative (fluid management to prevent nausea and vomiting, antiemetic use, analgesia with nonsteroidal antiinflammatory drugs/paracetamol, regular diet within 2 hours, tight capillary glucose control, pneumatic compression stocking for venous thromboembolism prophylaxis, immediate removal of urinary catheter). Recommendations against the element use were made for preoperative (maternal sedation, bowel preparation), intraoperative (neonatal oral suctioning or increased inspired oxygen), and postoperative (heparin should not be used routinely venous thromboembolism prophylaxis). Because these ERAS cesarean delivery pathway recommendations (elements/processes) are studied, implemented, audited, evaluated, and optimized by the maternity care teams, this will create an opportunity for the focused and optimized areas of care research with further enhanced care and recommendation.

Guidelines for intraoperative care in cesarean delivery: Enhanced Recovery After Surgery Society Recommendations (Part 2).

The Enhanced Recovery After Surgery Society guideline for intraoperative care in cesarean delivery will provide best practice, evidenced-based, recommendations for intraoperative care, with primarily a maternal focus. The "focused" pathway process for scheduled and unscheduled cesarean delivery for this Enhanced Recovery After Surgery cesarean delivery guideline will consider procedure from the decision to operate (starting with the 30-60 minutes before skin incision) through the surgery. The literature search (1966-2017) used Embase and PubMed to search medical subject headings including "cesarean section," "cesarean section," "cesarean section delivery," and all pre- and intraoperative Enhanced Recovery After Surgery items. Study selection allowed titles and abstracts to be screened by individual reviewers to identify potentially relevant articles. Metaanalyses, systematic reviews, randomized controlled studies, nonrandomized controlled studies, reviews, and case series were considered for each individual topic. Quality assessment and data analyses evaluated the quality of evidence and recommendations were evaluated according to the Grading of Recommendations, Assessment, Development and Evaluation system as used and described in previous Enhanced Recovery After Surgery Society guidelines. The Enhanced Recovery After Surgery cesarean delivery guideline/pathway has created a maternal focused pathway (for scheduled and unscheduled surgery starting from 30-60 minutes before skin incision to maternal discharge) with Enhanced Recovery After Surgery-directed preoperative elements, intraoperative elements, and postoperative elements. Specifics of the intraoperative care included the use of prophylactic antibiotics before the cesarean delivery, appropriate patient warming intraoperatively, blunt expansion of the transverse uterine hysterotomy, skin closure with subcuticular sutures, and delayed cord clamping. A number of specific elements of intraoperative care of women who undergo cesarean delivery are recommended based on the evidence. The Enhanced Recovery After Surgery Society guideline for intraoperative care in cesarean delivery will provide best practice, evidenced-based, recommendations for intraoperative care with primarily a maternal focus. When the cesarean delivery pathway (elements/processes) is studied, implemented, audited, evaluated, and optimized by maternity care teams, this will create an opportunity for the focused and optimized areas of care and recommendations to be further enhanced.

Cell salvage and donor blood transfusion during cesarean section: A pragmatic, multicentre randomised controlled trial (SALVO).

BACKGROUND: Excessive haemorrhage at cesarean section requires donor (allogeneic) blood transfusion. Cell salvage may reduce this requirement. METHODS AND FINDINGS: We conducted a pragmatic randomised controlled trial (at 26 obstetric units; participants recruited from 4 June 2013 to 17 April 2016) of routine cell salvage use (intervention) versus current standard of care without routine salvage use (control) in cesarean section among women at risk of haemorrhage. Randomisation was stratified, using random permuted blocks of variable sizes. In an intention-to-treat analysis, we used multivariable models, adjusting for stratification variables and prognostic factors identified a priori, to compare rates of donor blood transfusion (primary outcome) and fetomaternal haemorrhage ≥2 ml in RhD-negative women with RhD-positive babies (a secondary outcome) between groups. Among 3,028 women randomised (2,990 analysed), 95.6% of 1,498 assigned to intervention had cell salvage deployed (50.8% had salvaged blood returned; mean 259.9 ml) versus 3.9% of 1,492 assigned to control. Donor blood transfusion rate was 3.5% in the control group versus 2.5% in the intervention group (adjusted odds ratio [OR] 0.65, 95% confidence interval [CI] 0.42 to 1.01, p = 0.056; adjusted risk difference -1.03, 95% CI -2.13 to 0.06). In a planned subgroup analysis, the transfusion rate was 4.6% in women assigned to control versus 3.0% in the intervention group among emergency cesareans (adjusted OR 0.58, 95% CI 0.34 to 0.99), whereas it was 2.2% versus 1.8% among elective cesareans (adjusted OR 0.83, 95% CI 0.38 to 1.83) (interaction p = 0.46). No case of amniotic fluid embolism was observed. The rate of fetomaternal haemorrhage was higher with the intervention (10.5% in the control group versus 25.6% in the intervention group, adjusted OR 5.63, 95% CI 1.43 to 22.14, p = 0.013). We are unable to comment on long-term antibody sensitisation effects. CONCLUSIONS: The overall reduction observed in donor blood transfusion associated with the routine use of cell salvage during cesarean section was not statistically significant. TRIAL REGISTRATION: This trial was prospectively registered on ISRCTN as trial number 66118656 and can be viewed on http://www.isrctn.com/ISRCTN66118656.

Enhanced recovery after elective caesarean: a rapid review of clinical protocols, and an umbrella review of systematic reviews.

BACKGROUND: The rate of elective Caesarean Section (CS) is rising in many countries. Many obstetric units in the UK have either introduced or are planning to introduce enhanced recovery (ER) as a means of reducing length of stay for planned CS. However, to date there has been very little evidence produced regarding the necessary components of ER for the obstetric population. We conducted a rapid review of the composition of published ER pathways for elective CS and undertook an umbrella review of systematic reviews evaluating ER components and pathways in any surgical setting. METHODS: Pathways were identified using MEDLINE, EMBASE and the National Guideline Clearing House, appraised using the Appraisal of Guidelines for Research and Evaluation (AGREE II) tool and their components tabulated. Systematic reviews were identified using the Cochrane Library and Database of Abstracts of Reviews of Effects (DARE) and appraised using The Grading of Recommendations Assessment, Development and Evaluation (GRADE). Two reviewers aggregated summaries of findings for Length of Stay (LoS). RESULTS: Five clinical protocols were identified, involving a total of 25 clinical components; 3/25 components were common to all five pathways (early oral intake, mobilization and removal of urinary catheter). AGREE II scores were generally low. Systematic reviews of single components found that minimally invasive Joel-Cohen surgical technique, early catheter removal and post-operative antibiotic prophylaxis reduced LoS after CS most significantly by around half to 1 and a half days. Ten meta-analyses of multi-component Enhanced Recovery after Surgery (ERAS) packages demonstrated reductions in LoS of between 1 and 4 days. The quality of evidence was mostly low or moderate. CONCLUSIONS: Further research is needed to develop, using formal methods, and evaluate pathways for enhanced recovery in elective CS. Appropriate quality improvement packages are needed to optimise their implementation.

Cost-effectiveness of cell salvage and donor blood transfusion during caesarean section: results from a randomised controlled trial.

OBJECTIVES: To evaluate the cost-effectiveness of routine use of cell salvage during caesarean section in mothers at risk of haemorrhage compared with current standard of care. DESIGN: Model-based cost-effectiveness evaluation alongside a multicentre randomised controlled trial. Three main analyses were carried out on the trial data: (1) based on the intention-to-treat principle; (2) based on the per-protocol principle; (3) only participants who underwent an emergency caesarean section. SETTING: 26 obstetric units in the UK. PARTICIPANTS: 3028 women at risk of haemorrhage recruited between June 2013 and April 2016. INTERVENTIONS: Cell salvage (intervention) versus routine care without salvage (control). PRIMARY OUTCOME MEASURES: Cost-effectiveness based on incremental cost per donor blood transfusion avoided. RESULTS: In the intention-to-treat analysis, the mean difference in total costs between cell salvage and standard care was £83. The estimated incremental cost-effectiveness ratio (ICER) was £8110 per donor blood transfusion avoided. For the per-protocol analysis, the mean difference in total costs was £92 and the ICER was £8252. In the emergency caesarean section analysis, the mean difference in total costs was £55 and the ICER was £13 713 per donor blood transfusion avoided. This ICER is driven by the increased probability that these patients would require a higher level of postoperative care and additional surgeries. The results of these analyses were shown to be robust for the majority of deterministic sensitivity analyses. CONCLUSIONS: The results of the economic evaluation suggest that while routine cell salvage is a marginally more effective strategy than standard care in avoiding a donor blood transfusion, there is uncertainty in relation to whether it is a less or more costly strategy. The lack of long-term data on the health and quality of life of patients in both arms of the trial means that further research is needed to fully understand the cost implications of both strategies. TRIAL REGISTRATION NUMBER: ISRCTN66118656.

A randomised controlled trial and economic evaluation of intraoperative cell salvage during caesarean section in women at risk of haemorrhage: the SALVO (cell SALVage in Obstetrics) trial.

BACKGROUND: Caesarean section is associated with blood loss and maternal morbidity. Excessive blood loss requires transfusion of donor (allogeneic) blood, which is a finite resource. Cell salvage returns blood lost during surgery to the mother. It may avoid the need for donor blood transfusion, but reliable evidence of its effects is lacking. OBJECTIVES: To determine if routine use of cell salvage during caesarean section in mothers at risk of haemorrhage reduces the rates of blood transfusion and postpartum maternal morbidity, and is cost-effective, in comparison with standard practice without routine salvage use. DESIGN: Individually randomised controlled, multicentre trial with cost-effectiveness analysis. Treatment was not blinded. SETTING: A total of 26 UK obstetric units. PARTICIPANTS: Out of 3054 women recruited between June 2013 and April 2016, we randomly assigned 3028 women at risk of haemorrhage to cell salvage or routine care. Randomisation was stratified using random permuted blocks of variable sizes. Of these, 1672 had emergency and 1356 had elective caesareans. We excluded women for whom cell salvage or donor blood transfusion was contraindicated. INTERVENTIONS: Cell salvage (intervention) versus routine care without salvage (control). In the intervention group, salvage was set up in 95.6% of the women and, of these, 50.8% had salvaged blood returned. In the control group, 3.9% had salvage deployed. MAIN OUTCOME MEASURES: Primary - donor blood transfusion. Secondary - units of donor blood transfused, time to mobilisation, length of hospitalisation, mean fall in haemoglobin, fetomaternal haemorrhage (FMH) measured by Kleihauer-Betke test, and maternal fatigue. Analyses were adjusted for stratification factors and other factors that were believed to be prognostic a priori. Cost-effectiveness outcomes - costs of resources and service provision taking the UK NHS perspective. RESULTS: We analysed 1498 and 1492 participants in the intervention and control groups, respectively. Overall, the transfusion rate was 2.5% in the intervention group and 3.5% in the control group [adjusted odds ratio (OR) 0.65, 95% confidence interval (CI) 0.42 to 1.01; p = 0.056]. In a planned subgroup analysis, the transfusion rate was 3.0% in the intervention group and 4.6% in the control group among emergency caesareans (adjusted OR 0.58, 95% CI 0.34 to 0.99), whereas it was 1.8% in the intervention group and 2.2% in the control group among elective caesareans (adjusted OR 0.83, 95% CI 0.38 to 1.83) (interaction p = 0.46, suggesting that the difference in effect between subgroups was not statistically significant). Secondary outcomes did not differ between groups, except for FMH, which was higher under salvage in rhesus D (RhD)-negative women with RhD-positive babies (25.6% vs. 10.5%, adjusted OR 5.63, 95% CI 1.43 to 22.14; p = 0.013). No case of amniotic fluid embolism was observed. The additional cost of routine cell salvage during caesarean was estimated, on average, at £8110 per donor blood transfusion avoided. CONCLUSIONS: The modest evidence for an effect of routine use of cell salvage during caesarean section on rates of donor blood transfusion was associated with increased FMH, which emphasises the need for adherence to guidance on anti-D prophylaxis. We are unable to comment on long-term antibody sensitisation effects. Based on the findings of this trial, cell salvage is unlikely to be considered cost-effective. FUTURE WORK: Research into risk of alloimmunisation among women exposed to cell salvage is needed. TRIAL REGISTRATION: Current Controlled Trials ISRCTN66118656. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 22, No. 2. See the NIHR Journals Library website for further project information.

How do memory processes relate to the development of posttraumatic stress symptoms following childbirth?

Some women develop posttraumatic stress symptoms (PTSS) following childbirth but little is known about memory processes following childbirth. Models of traumatic memory debate the role of memory disorganization. This study investigates whether there is an association between memory disorganization and PTSS in new mothers. One hundred and twenty-two women were recruited within 72h of giving birth, completing measures of cognitive and emotional experience, and analgesia, and a narrative account of the birth. 68 of these women responded to a six-week follow-up and completed measures of memory disorganization and PTSS. There was a relationship between memory disorganization and PTSS at follow-up, but not at recruitment. The organization of the immediate narrative may not distinguish between those who later do or do not develop symptoms. Emotional evaluation may be the key factor in facilitating or inhibiting the memory construction process, linking memory to subsequent disorganization and hence to symptoms.