Perineal resuturing versus expectant management following vaginal delivery complicated by a dehisced wound (PREVIEW): a nested qualitative study

Dudley, Lynn; Kettle, Christine; Waterfield, Jackie; Ismail, Khaled

doi:10.1136/bmjopen-2016-013008

Cited by 25 publications

(40 citation statements)

References 42 publications

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“…In this study, we confirmed women did suffer perineal pain or discomfort, consistent with qualitative and quantitative studies. 31 38 39 In addition, women in this study complained more about the unabsorbed stitches or split of stitches. Many reviews also indicate there are a few women who need removal or resuture services due to factors such as materials or skills.…”

Section: Discussionmentioning

confidence: 68%

“…We used an interview guide based on the literature and our research group discussions (Box 1). [29][30][31] We also reviewed women's comments on the public internet forum to improve the design of the interview guide and piloted the interview guide with four postpartum women. The piloted data were also included in our analysis as these were consistent with the main sample.…”

Section: Data Collectionmentioning

confidence: 99%

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Women’s experience of episiotomy: a qualitative study from China

Jiang

Qian

et al. 2020

BMJ Open

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ObjectiveTo describe women’s experience of episiotomy in urban China.DesignThis is a semistructured, indepth interview with women after episiotomy. We analysed transcriptions using thematic analysis in Chinese. Emerging themes were debated in English to finalise interpretation.SettingTwo community health centres and four hospitals in Shanghai, China.ParticipantsPurposive sampling of 30 postpartum women who had experienced episiotomy; 25 were primiparous and 4 had deliveries by forceps. We interviewed health providers to complement the data.ResultsWe identified four main themes: (1) women’s views of the procedure vary considerably; (2) pain interferes with daily life for weeks; (3) long-term anxiety is a consequence for some, described as a ‘psychological shadow’; and (4) societal norms assume women will not complain.ConclusionWomen receive little information in advance about episiotomy, yet the procedure has a wide range of physical and psychological consequences. This includes long-term anxiety about the damage done to them as women.

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Section: Discussionmentioning

confidence: 68%

Section: Data Collectionmentioning

confidence: 99%

Women’s experience of episiotomy: a qualitative study from China

Jiang

Qian

et al. 2020

BMJ Open

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“…In a nested qualitative study, 26 women were interviewed as part of the PREVIEW study to explore their physical and psychological experiences following perineal wound dehiscence, to assess the acceptability of the research plan and ensure that all outcomes relevant to women are included in the definitive trial.…”

Section: Resultsmentioning

confidence: 99%

Perineal resuturing versus expectant management following vaginal delivery complicated by a dehisced wound (PREVIEW): a pilot and feasibility randomised controlled trial

et al. 2017

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ObjectiveTo establish the feasibility of conducting a definitive randomised controlled trial (RCT) comparing the effectiveness of resuturing versus expectant management for dehisced perineal wounds.DesignA multicentre pilot and feasibility RCT.SettingTen UK maternity units from July 2011 to July 2013.PopulationEligible women with a dehisced perineal wound within 2 weeks of childbirth.MethodsThe interventions were resuturing or expectancy. Randomisation was via web or telephone, stratified by participating centre. Blinding was not possible due to the nature of the interventions. Analysis was by intention-to-treat.OutcomeThe primary outcome measure was wound healing at 6–8 weeks.ResultsThe study revealed a number of feasibility issues, particularly strong patient and clinician preference for treatment options at recruiting centres and the timing of the primary outcome measure. Thirty-four women were randomised (17 in each arm). Data from 33 women were analysed on an intention-to-treat analysis to obtain preliminary estimates of effect size. There was a difference in wound healing at 2 weeks favouring resuturing (OR 20.00, 95% CI 2.04 to 196.37, p=0.004). However, by 6–8 weeks all but one wound in both groups had healed.ConclusionsPREVIEW revealed a number of feasibility issues, which impacted on recruitment rate. These will have to be taken into account in the design of any future definitive study. In this feasibility study, resuturing was associated with quicker wound healing and women reported higher satisfaction rates with the outcome at 3 months.Trial registration numberISRCTN05754020.

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“…One in five women in the placebo arm and one in 10 in the antibiotic arm reported that they had experienced perineal wound breakdown. Although a previous feasibility study reported that most women whose perineal wound had dehisced had healed by 6-8 weeks, 35 women described long-term impacts 6-9 months later, 37 including psychosexual morbidity. It is therefore probable that the almost 50% reduction in wound breakdown reported in the antibiotic arm is associated with longer-term benefit on sexual function, even though we observed no difference in dyspareunia between the groups at 6 weeks post partum.…”

Section: Comparison With Existing Literaturementioning

confidence: 91%

“…33 Perineal pain/use of pain relief/dyspareunia/ability to sit comfortably to feed the baby/need for additional perineal care/breastfeeding This was identified using standard questions developed for the HOOP (Hands On Or Poised) study 34 and the PREVIEW (PREVention of diabetes through lifestyle intervention and population studies In Europe and around the World) study. 37…”

Section: Surgical Site Infection (Perineal)mentioning

confidence: 99%

Intravenous co-amoxiclav to prevent infection after operative vaginal delivery: the ANODE RCT

Knight

Chiocchia

Partlett

et al. 2019

Health Technol Assess

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Background Sepsis is a leading cause of direct and indirect maternal death in both the UK and globally. All forms of operative delivery are associated with an increased risk of sepsis, and the National Institute for Health and Care Excellence’s guidance recommends the use of prophylactic antibiotics at all caesarean deliveries, based on substantial randomised controlled trial evidence of clinical effectiveness. A Cochrane review, updated in 2017 (Liabsuetrakul T, Choobun T, Peeyananjarassri K, Islam QM. Antibiotic prophylaxis for operative vaginal delivery. Cochrane Database Syst Rev 2017;8:CD004455), identified only one small previous trial of prophylactic antibiotics following operative vaginal birth (forceps or ventouse/vacuum extraction) and, given the small study size and extreme result, suggested that further robust evidence is needed. Objectives To investigate whether or not a single dose of prophylactic antibiotic following operative vaginal birth is clinically effective for preventing confirmed or presumed maternal infection, and to investigate the associated impact on health-care costs. Design A multicentre, randomised, blinded, placebo-controlled trial. Setting Twenty-seven maternity units in the UK. Participants Women who had an operative vaginal birth at ≥ 36 weeks’ gestation, who were not known to be allergic to penicillin or constituents of co-amoxiclav and who had no indication for ongoing antibiotics. Interventions A single dose of intravenous co-amoxiclav (1 g of amoxicillin/200 mg of clavulanic acid) or placebo (sterile saline) allocated through sealed, sequentially numbered, indistinguishable packs. Main outcome measures Primary outcome – confirmed or suspected infection within 6 weeks of giving birth. Secondary outcomes – severe sepsis, perineal wound infection, perineal pain, use of pain relief, hospital bed stay, hospital/general practitioner visits, need for additional perineal care, dyspareunia, ability to sit comfortably to feed the baby, maternal general health, breastfeeding, wound breakdown, occurrence of anaphylaxis and health-care costs. Results Between March 2016 and June 2018, 3427 women were randomised: 1719 to the antibiotic arm and 1708 to the placebo arm. Seven women withdrew, leaving 1715 women in the antibiotic arm and 1705 in the placebo arm for analysis. Primary outcome data were available for 3225 out of 3420 women (94.3%). Women randomised to the antibiotic arm were significantly less likely to have confirmed or suspected infection within 6 weeks of giving birth (180/1619, 11%) than women randomised to the placebo arm (306/1606, 19%) (relative risk 0.58, 95% confidence interval 0.49 to 0.69). Three serious adverse events were reported: one in the placebo arm and two in the antibiotic arm (one was thought to be causally related to the intervention). Limitations The follow-up rate achieved for most secondary outcomes was 76%. Conclusions This trial has shown clear evidence of benefit of a single intravenous dose of prophylactic co-amoxiclav after operative vaginal birth. These results may lead to reconsideration of official policy/guidance. Further analysis of the mechanism of action of this single dose of antibiotic is needed to investigate whether earlier, pre-delivery or repeated administration could be more effective. Until these analyses are completed, there is no indication for administration of more than a single dose of prophylactic antibiotic, or for pre-delivery administration. Trial registration Current Controlled Trials ISRCTN11166984. Funding This project was funded by the National Institute for Health Research Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 23, No. 54. See the National Institute for Health Research Journals Library website for further project information.

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Perineal resuturing versus expectant management following vaginal delivery complicated by a dehisced wound (PREVIEW): a nested qualitative study

Cited by 25 publications

References 42 publications

Women’s experience of episiotomy: a qualitative study from China

Women’s experience of episiotomy: a qualitative study from China

Perineal resuturing versus expectant management following vaginal delivery complicated by a dehisced wound (PREVIEW): a pilot and feasibility randomised controlled trial

Intravenous co-amoxiclav to prevent infection after operative vaginal delivery: the ANODE RCT

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