Background In England, 27.8% of all pregnant women undergo caesarean sections (CS) to deliver their babies. Women undergoing CS are at risk of developing sepsis and post-natal infections, which not only contribute significantly to maternal mortality and morbidity, but also negatively impact upon post-natal recovery and wellbeing. This study explores patients’ priorities in relation to CS recovery, focusing on their knowledge and experiences of infection prevention. The study formed part of the PREPS (Vaginal Preparation at caesarean section to Reduce Endometritis and Prevent Sepsis – a feasibility study of chlorhexidine) Trial; patients’ views on the PREPS Trial were also sought. Methods Using qualitative methodology, two focus groups and six telephone interviews were carried out between September and October 2017 with a total of 21 women who had undergone a CS within the preceding six months. Focus groups and individual telephone interviews were audio-recorded and transcribed verbatim; a thematic analysis was conducted using NVivo 11. Results Women’s priorities around CS recovery centred on pain (or the lack thereof), mobility and the ability to resume everyday activities, including caregiving. Those undergoing a CS for the first time reported not feeling confident in their ability to identify signs of infection and sought visiting health professionals’ expertise and reassurance. Women were unable to recall whether they had received information regarding infection prevention and felt that they had not received sufficient advice. Some reported receiving general information regarding CS recovery, which ranged in quality. Prevention of womb infection is a major goal of the PREPS trial, however, the majority of women were not aware that womb (as opposed to wound) infection was a post CS risk. Conclusions Women undergoing a CS want more information on what constitutes a ‘normal’ post-operative recovery and specifically would welcome written information and infection prevention advice. This should be a key element of improving post-CS maternal experiences and potentially reducing sepsis and infection rates. CS stigma negatively impacts women’s recovery experiences and possibly information provision. The PREPS team incorporated findings regarding consent pathways for recruiting women into intrapartum research and developed two patient reported outcomes to collect in the main trial. Trial registration The PREPS trial has been registered with ISRCTN on the 10th July 2017 ( ISRCTN33435996 ).
BackgroundWorldwide caesarean section (CS) delivery is the most common major operation. Approximately 25% of pregnant women undergo a CS in the UK for delivery of their babies. Sepsis and post-natal infection constitute significant maternal mortality and morbidity. Infection following a CS has a number of primary sources including endometritis occurring in 7–17% of women. Sepsis reduction and reduction in antibiotic use have been identified as a national and international priority. The overarching aim of this research is to reduce infectious morbidity from caesarean sections.MethodsThis is a parallel group feasibility randomised controlled trial comparing vaginal cleansing using chlorhexidine gluconate versus no cleansing (standard practice) at CS to reduce infection. Women will be recruited from four National Health Service maternity units. Two hundred fifty women (125 in each arm) undergoing elective or emergency CS, who are aged 16 years and above, and at least 34 weeks pregnant will be randomised. Allocation to treatment will be on a 1:1 ratio. The study includes a qualitative aspect to develop women centred outcomes of wellbeing after delivery.DiscussionThe success of the feasibility study will be assessed by criteria related to the feasibility measurements to ascertain if a larger study is feasible in its current format, needs modification or is unfeasible, and includes recruitment, adherence, follow-up and withdrawal measures.Trial registrationThe PREPS trial has been registered with ISRCTN (ISRCTN 33435996).
Twin pregnancy has risks of adverse outcomes for mother and baby. Data synthesis is required to gain evidence to aid recommendations but may be hampered by variations in outcome reporting. Study design: Systematically review outcomes reported in twin pregnancy trials (PROSPERO -CRD42019133805). Searches were performed in MEDLINE, EMBASE, CINHAL, Cochrane library (inception-January 2019) for randomised control trials or their follow-up studies reporting prediction, prognosis, intervention or management outcomes in twin pregnancy. The study characteristics, outcomes definitions and measurements were extracted and descriptively analysed. Results: 49 RCTs and 8 follow-up studies evaluated 21 interventions, 1257 outcomes, categorised into 170 unique outcomes. 65 % of trials included all twin pregnancies, 12 % DCDA and 11 % MCDA only or MCMA and MCDA. Five (9 %) papers were prediction/ prognosis RCT's and 52 (91 %) related to an intervention. Of interventions, 40 (77 %) were medical, 34 (85 %) for preterm birth; 12 (23 %) surgical, 6 (50 %) related to TTTS interventions (83 % for monochrorionic studies). Commonest domains were: 'Neonatal' 77 %, 'Delivery' 70 % and 'Survival' 67 %. Least reported were longer term outcomes for 'Infant' or 'Parental'. Conclusions: Twin pregnancy outcomes are diverse and complex. This is related to the need to address maternal, single and double fetal outcomes and different types of chorionicity. The lack of outcome standardisation in selection, definition and reporting hinders evidence synthesis and the selection of outcomes important to women and health care professionals thus limiting the effectiveness of research.
Introduction: Cesarean sections are the most common major operation worldwide. One in 10 women develops a surgical-site infection after cesarean section. The PREPS pilot trial was developed to assess the feasibility of a randomized controlled trial of vaginal cleansing with chlorhexidine before cesarean section, to reduce infectious morbidity. Material and methods:A multi-center, open-label, parallel-group pilot randomized controlled trial across 4 UK maternity units. Women aged ≥16 years, undergoing elective or emergency cesarean section, ≥34 weeks of gestation, and able to give informed consent were eligible. Women were randomized 1:1 to chlorhexidine 0.05% or no cleansing and were followed up until 6 weeks after cesarean section.The feasibility of a larger randomized controlled trial was assessed by the pilot trial's recruitment, ability to use verbal consent in an emergency, adherence, follow-up and withdrawal rates. The main clinical outcome collected was Center for Disease Control and Prevention (CDC) classification of endometritis at 30 days. Trial registration number is ISRCTN33435996.Results: A total of 320 women (128% of target) were randomized. Of these, 93% (95% CI 89%-95%) received their allocated intervention. Of the 88 women who had an emergency cesarean section, verbal consent was initially given by 32 (36%) women, with the remainder having sufficient time to give written consent. Endometritis (CDC definition) was collected from medical notes of 96% of women, 68% (95% CI 63%-73%) were followed up at both 14 and 30 days by telephone, and we were able to collect patient-reported outcomes. In the vaginal cleansing arm 2/152 (1.3%) women had endometritis compared with 1/155 (0.7%) in the no cleansing arm (RR 2.08, 95% CI 0.19-22.31). Conclusions:It is possible to perform a randomized controlled trial in women undergoing an elective or emergency cesarean section, using a verbal-followed-by-written consent process, while maintaining high adherence and retaining women in the trial. 232 | MORTON eT al. 1 | INTRODUC TI ON Cesarean section (CS) is the commonest major operation worldwide; approximately 26% of pregnant women undergo a CS in the UK, equating to 177 793 per year in England. 1 One in 10 women experience a surgical-site infection (SSI) post-CS, with 90% of infections being in the abdominal wound, 5% deep incisional, and 5% endometritis. 2 The post-CS endometritis rate varies from 0.94% to 15.8%, 3 because of changes in practice related to the routine introduction of antibiotic prophylaxis (reducing endometritis from 15.7% to 5.7%) and the definition of endometritis used (eg clinically determined or Center for Disease Control and Prevention [CDC] criteria 4 ). Complications range from community-managed mild infections to sepsis requiring high-dependency care. Although maternal mortality rates from sepsis have reduced, this is a result of early identification and treatment, and reducing influenza in pregnancy through vaccination. 5 Of the women developing an SSI post-CS, 6 in 1000 require re-admiss...
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