Dataset Information

One Plus One Equals Two-will that do? A trial protocol for a Swedish multicentre randomised controlled trial to evaluate a clinical practice to reduce severe perineal trauma {1}.

ABSTRACT: Background: Severe perineal trauma sustained during childbirth is a serious complication since it can lead to both short- and long-term consequences for women. Some of the methods used to prevent perineal injuries have been evaluated in clinical trials, but there are still gaps in the evidence. A new clinical practice has been introduced, adopted by more than half of the maternity wards in Sweden with the aim of reducing severe perineal trauma. This procedure involves two midwives assisting the woman during the second stage of labour.

Methods/design: In this multicentre randomised controlled trial, 2946 women will be randomised to be assisted by one or two midwives during the second stage of labour. Women age 18-47, who plan for their first vaginal birth, with a singleton pregnancy in cephalic presentation, will be asked to participate when admitted to the maternity ward. Five maternity wards comprising 19,500 births/year in different parts of Sweden will participate in this study. The sample size is powered to demonstrate a 50% reduction (from 4.1-2.0%) in primary outcome, which is the prevalence of severe perineal trauma (3rd and 4th degree). Secondary outcomes will include maternal and neonatal outcomes, women's experiences, midwives' experiences of the intervention, incontinence, and pelvic floor symptoms. The primary analysis is intention to treat. Questionnaires will be sent to the women at 1 month and 1 year after the birth to assess women's experiences, pain, incontinence, pelvic floor symptoms, sexual function, and mental health.

Discussion: It is important for care during labour and birth to be evidence based. There is a strong desire among midwives to reduce the risk of severe perineal trauma. This may lead to new strategies and practices being implemented into practice without scientific evidence. The intervention might have negative side effects or unintended consequences. On the other hand, there is a possibility of the intervention improving care for women. TRIAL REGISTRATION {2A}: ClinicalTrials.gov NCT03770962 . Registered on 10 December 2018.

SUBMITTER: Edqvist M

PROVIDER: S-EPMC7682019 | biostudies-literature | 2020 Nov

REPOSITORIES: biostudies-literature

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One Plus One Equals Two-will that do? A trial protocol for a Swedish multicentre randomised controlled trial to evaluate a clinical practice to reduce severe perineal trauma {1}.

Edqvist M M Dahlen H G HG Häggsgård C C Tern H H Ängeby K K Tegerstedt G G Teleman P P Ajne G G Rubertsson C C

Trials 20201123 1

<h4>Background</h4>Severe perineal trauma sustained during childbirth is a serious complication since it can lead to both short- and long-term consequences for women. Some of the methods used to prevent perineal injuries have been evaluated in clinical trials, but there are still gaps in the evidence. A new clinical practice has been introduced, adopted by more than half of the maternity wards in Sweden with the aim of reducing severe perineal trauma. This procedure involves two midwives assisti ...[more]

PMID: 33225972

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Project description:IntroductionPhotobiomodulation (PBM) using low-level laser can affect tissue repair mechanisms and seems promising in reducing pain intensity. However, few studies support the effectiveness of PBM on postpartum period complications, such as nipple and/or perineal trauma and pain, probably due to the low doses used. The primary objective of this study is to analyse the effectiveness of PBM on pain intensity in the nipple and perineal trauma in women in the immediate postpartum period. Secondary objectives are to evaluate the effect on tissue healing and the women's satisfaction.Methods and analysisA double-blind, multicentre, parallel-group, randomised controlled trial will be performed in two public referral maternity hospitals in Brazil with 120 participants, divided into two arms: 60 participants in the nipple trauma arm and 60 participants in the perineal trauma arm. Participants will be women in the immediate postpartum period, who present with nipple trauma or perineal trauma and report pain intensity greater than or equal to 4 points on the Numerical Rating Scale for Pain. Block randomisation will be performed, followed by blinding allocation. In the experimental group, one application of PBM will be performed between 6 hours and 36 hours after birth. For the sham group, the simulation will be carried out without triggering energy. Both participants and the research evaluator will be blinded to the allocation group. Intention-to-treat method and the between-group and within-group outcome measures analysis will be performed.Ethics and disseminationThis research protocol was approved by the Research Ethics Committees of the University of Campinas, Brazil, and of the School Maternity Assis Chateaubriand, Brazil (numbers CAAE: 59400922.1.1001.5404; 59400922.1.3001.5050). Participants will be required to sign the informed consent form to participate. Results will be disseminated to the health science community.Trial registration numberBrazilian Registry of Clinical Trials (RBR-2qm8jrp).

Project description:IntroductionHaemorrhage causes most preventable prehospital trauma deaths and about a third of in-hospital trauma deaths. Tranexamic acid (TXA), administered soon after hospital arrival in certain trauma systems, is an effective therapy in preventing or managing acute traumatic coagulopathy. However, delayed administration of TXA appears to be ineffective or harmful. The effectiveness of prehospital TXA, incidence of thrombotic complications, benefit versus risk in advanced trauma systems and the mechanism of benefit remain uncertain.Methods and analysisThe Pre-hospital Anti-fibrinolytics for Traumatic Coagulopathy and Haemorrhage (The PATCH-Trauma study) is comparing TXA, initiated prehospital and continued in hospital over 8 hours, with placebo in patients with severe trauma at risk of acute traumatic coagulopathy. We present the trial protocol and an overview of the statistical analysis plan. There will be 1316 patients recruited by prehospital clinicians in Australia, New Zealand and Germany. The primary outcome will be the eight-level Glasgow Outcome Scale Extended (GOSE) at 6 months after injury, dichotomised to favourable (GOSE 5-8) and unfavourable (GOSE 1-4) outcomes, analysed using an intention-to-treat (ITT) approach. Secondary outcomes will include mortality at hospital discharge and at 6 months, blood product usage, quality of life and the incidence of predefined adverse events.Ethics and disseminationThe study was approved by The Alfred Hospital Research and Ethics Committee in Victoria and also approved in New South Wales, Queensland, South Australia, Tasmania and the Northern Territory. In New Zealand, Northern A Health and Disability Ethics Committee provided approval. In Germany, Witten/Herdecke University has provided ethics approval. The PATCH-Trauma study aims to provide definitive evidence of the effectiveness of prehospital TXA, when used in conjunction with current advanced trauma care, in improving outcomes after severe injury.Trial registration numberNCT02187120.

Project description:BackgroundGenital numbness and erectile dysfunction in cyclists may result from repeated perineal impacts on the bicycle saddle (micro-trauma) that occur during routine cycling.AimTo evaluate the relationship between oscillation forces and perineal pressures among cyclists in a simulated laboratory setting.MethodsParticipants were fit to a study bicycle to ensure all cyclists had the same torso angle (60 ± 1 degree) and maximum knee angle (150 ± 1 degree). A lever system was used to generate oscillation events of 3 progressively increasing magnitudes. Perineal pressure was continuously measured using a pressure sensor on the bicycle saddle. This process was carried out in each of the following conditions: (1) stationary (not pedaling) with the standard seatpost, (2) pedaling with standard seatpost, (3) stationary with seatpost shock absorber, and (4) pedaling with seatpost shock absorber.OutcomesWe compared perineal pressure changes during oscillation events in the stationary and pedaling states, with and without the seatpost shock absorber.ResultsA total of 39 individuals were recruited (29 men and 10 women). As the amount of oscillation increased from an average of 0.7g (acceleration due to Earth's gravity) to 1.3g, the perineal pressure increased from 10.3% over baseline to 19.4% over baseline. There was a strong linear relationship between the amount of oscillation and increase in pressure (r2 = 0.8, P < .001). A seatpost shock absorber decreased the impact of oscillation by 53% in the stationary condition. Men and women absorbed the majority of shock in areas corresponding to pelvic bony landmarks.ConclusionThis study represents one of the first characterizations of cycling-associated perineal micro-trauma in a laboratory setting. We found a strong linear relationship between oscillation magnitude and perineal pressure during cycling, which was mitigated by a seatpost shock absorber. The use of shock absorption in bicycle design may reduce perineal micro-trauma and potentially improve cycling-associated perineal numbness and erectile dysfunction. Sanford T, Gadzinski AJ, Gaither T, et al. Effect of Oscillation on Perineal Pressure in Cyclists: Implications for Micro-Trauma. Sex Med 2018;6:239-247.

Project description:IntroductionPerineal lacerations during childbirth are common, and suturing the perineal skin during repair has been associated with increased postpartum pain. This study sought to test the hypothesis that no difference in postpartum perineal pain exists between 3 methods of skin closure for second-degree repair: suture, no suture, and surgical glue.MethodsA single-blind randomized controlled trial of women after vaginal birth who had a second-degree perineal laceration was conducted at a tertiary care teaching hospital from August 2014 to April 2017. Women were randomized to perineal skin closure with suture, no suture, or surgical glue using a 1:1:1 allocation. Pain was assessed using the short-form McGill Pain Questionnaire, a 100-mm visual analog scale (VAS), and Present Pain Index (PPI) at one day, 2 weeks, 6 weeks, and 3 months postpartum. Wound healing was assessed at 6 weeks using the Redness, Edema, Ecchymosis, Drainage, Approximation (REEDA) scale. Pain scores were compared across groups using a chi-square test, Mann-Whitney U test, or analysis of variance where appropriate.ResultsA total of 35 women were randomized: 14 received suture, 11 had no suture, and 10 received surgical glue for perineal skin repair. Demographic characteristics were similar between groups. At 2 weeks postpartum, women with suture had higher median pain scores on the short-form McGill Pain Questionnaire (15.0 suture vs 2.0 glue vs 2.0 no suture, P = .03) and VAS (50.0 suture vs 3.0 glue vs 7.0 no suture, P = .02). Significant differences in pain were not seen on the PPI. At 3 months, women in the suture group had higher median pain scores on the short-form McGill Pain Questionnaire compared with surgical glue (1.0 vs 0, P = .04). Wound healing was similar across groups (REEDA score: 0 suture vs 1.0 no suture, vs 0 surgical glue, P = .24).DiscussionCompared with no suture and surgical glue, suturing the perineal skin was associated with the highest postpartum pain scores.

Dataset Information

One Plus One Equals Two-will that do? A trial protocol for a Swedish multicentre randomised controlled trial to evaluate a clinical practice to reduce severe perineal trauma {1}.

Publications

One Plus One Equals Two-will that do? A trial protocol for a Swedish multicentre randomised controlled trial to evaluate a clinical practice to reduce severe perineal trauma {1}.

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