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Selective episiotomy vs. implementation of a non episiotomy protocol: a randomized clinical trial.

ABSTRACT: World Health Organization (WHO) recommends that the episiotomy rate should be around 10%, which is already a reality in many European countries. Currently the use of episiotomy should be restricted and physicians are encouraged to use their clinical judgment to decide when the procedure is necessary. There is no clinical evidence corroborating any indication of episiotomy, so until the present moment it is not yet known whether episiotomy is indeed necessary in any context of obstetric practice.To compare maternal and perinatal outcomes in women undergoing a protocol of not performing episiotomy versus selective episiotomy.An open label randomized clinical trial will be conducted including laboring women with term pregnancy, maximum dilation of 8 cm, live fetus in cephalic vertex presentation. Women with bleeding disorders of pregnancy, indication for caesarean section and those without capacity to consent and without legal guardians will be excluded. Primary outcomes will be frequency of episiotomy, delivery duration, frequency of spontaneous lacerations and perineal trauma, frequency of instrumental delivery, postpartum blood loss, need for perineal suturing, number of sutures, Apgar scores at one and five minutes, need for neonatal resuscitation and pH in cord blood. As secondary outcomes frequency complications of perineal suturing, postpartum perineal pain, maternal satisfaction, neonatal morbidity and admission newborn in NICU will be assessed. Women will be invited to participate and those who agree will sign the consent form and will be then assigned to a protocol of not conducting episiotomy (experimental group) or to a group that episiotomy is performed selectively according to the judgment of the provider of care delivery (control Group). The present study was approved by IMIP's Research Ethics Committee.Clinical Trials Register under the number and was registered in ClinicalTrials.gov under the number NCT02178111.

SUBMITTER: Melo I

PROVIDER: S-EPMC4142063 | biostudies-literature | 2014 Aug

REPOSITORIES: biostudies-literature

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Project description:BackgroundDespite all the evidence corroborating the selective use of episiotomy and although routine use of the procedure is contraindicated, there are no evidences corroborating if episiotomy is necessary in any circumstance. The present clinical randomized trial was performed to compare maternal and perinatal outcomes in women submitted to a non-episiotomy protocol versus one of selective episiotomy.MethodsAn open-labelled, randomized clinical trial was carried out in a tertiary teaching hospital in Recife, Northeastern Brazil. Women in labor with a full-term live foetus, dilatation of 6 to 8 cm and cephalic presentation (vertex position) were included. Exclusion criteria consisted of bleeding disorders and an indication for a caesarean section. After signing the consent form, 241 women were randomized to a non-episiotomy protocol (the experimental group) or to a selective episiotomy group (the control group). No episiotomies were to be performed in the experimental group except under exceptional circumstances. In the control group, selective episiotomies were to be performed in accordance with the healthcare professionals' clinical judgement. Maternal and perinatal outcomes were evaluated. Ratio Risk (RR) and the 95% confidence interval (95% CI) were calculated for our outcomes.ResultsThe analysis include 115 women assigned to a non-episiotomy protocol and 122 to selective episiotomy. There was no difference between the two groups with respect to maternal or perinatal outcomes. The episiotomy rate was similar (two cases in each group, about 1.7%), as was the duration of the second stage of labor, the frequency of perineal tears, severe perineal trauma, need for perineal suturing and blood loss at delivery.ConclusionsA non-episiotomy protocol appears to be safe for mother and child, and highlights the need to investigate whether there is, in fact, any indication for this procedure.Trial registrationThis trial was registered at ClinicalTrials.gov under reference number ( NCT02178111 ).

Project description:BackgroundSelective cyclooxygenase-2 inhibitors and conventional non-selective non-steroidal anti-inflammatory drugs (nsNSAIDs) have been associated with adverse cardiovascular (CV) effects. We compared the CV safety of switching to celecoxib vs. continuing nsNSAID therapy in a European setting.MethodPatients aged 60 years and over with osteoarthritis or rheumatoid arthritis, free from established CV disease and taking chronic prescribed nsNSAIDs, were randomized to switch to celecoxib or to continue their previous nsNSAID. The primary endpoint was hospitalization for non-fatal myocardial infarction or other biomarker positive acute coronary syndrome, non-fatal stroke or CV death analysed using a Cox model with a pre-specified non-inferiority limit of 1.4 for the hazard ratio (HR).ResultsIn total, 7297 participants were randomized. During a median 3-year follow-up, fewer subjects than expected developed an on-treatment (OT) primary CV event and the rate was similar for celecoxib, 0.95 per 100 patient-years, and nsNSAIDs, 0.86 per 100 patient-years (HR = 1.12, 95% confidence interval, 0.81-1.55; P = 0.50). Comparable intention-to-treat (ITT) rates were 1.14 per 100 patient-years with celecoxib and 1.10 per 100 patient-years with nsNSAIDs (HR = 1.04; 95% confidence interval, 0.81-1.33; P = 0.75). Pre-specified non-inferiority was achieved in the ITT analysis. The upper bound of the 95% confidence limit for the absolute increase in OT risk associated with celecoxib treatment was two primary events per 1000 patient-years exposure. There were only 15 adjudicated secondary upper gastrointestinal complication endpoints (0.078/100 patient-years on celecoxib vs. 0.053 on nsNSAIDs OT, 0.078 vs. 0.053 ITT). More gastrointestinal serious adverse reactions and haematological adverse reactions were reported on nsNSAIDs than celecoxib, but more patients withdrew from celecoxib than nsNSAIDs (50.9% patients vs. 30.2%; P < 0.0001).InterpretationIn subjects 60 years and over, free from CV disease and taking prescribed chronic nsNSAIDs, CV events were infrequent and similar on celecoxib and nsNSAIDs. There was no advantage of a strategy of switching prescribed nsNSAIDs to prescribed celecoxib. This study excluded an increased risk of the primary endpoint of more than two events per 1000 patient-years associated with switching to prescribed celecoxib.Clinical trial registrationhttps://clinicaltrials.gov/show/NCT00447759; Unique identifier: NCT00447759.

Project description:BACKGROUND:Proximal humerus fractures are the third most common fracture in the elderly population and are expected to increase due to the aging population. Surgical fixation with locking plate technology has increased over the last decade despite a lack of proven superiority in the literature. Three previous randomized controlled trials have not shown a difference in patient-centered outcomes when comparing non-operative treatment with open reduction and internal fixation. Low patient enrollment and other methodological concerns however limit the generalizability of these conclusions and as a result, management of these fractures remains a controversy. By comparing the functional outcomes of locked plate surgical fixation versus non-operative treatment of displaced three and four-part proximal humerus fractures in the elderly population with a large scale, prospective, multi-centered randomized controlled trial, the optimal management strategy for this common injury may be determined. METHODS:We will conduct a prospective, single blind randomized controlled parallel arm trial to compare non-operative management of proximal humerus fractures with open reduction and internal fixation using locked plating technology. One-hundred and sixty patients > age 60 with acute 3- or 4- part proximal humerus fractures will be randomized to either open reduction and internal fixation with locked plating technology or non-operative management treatment arms. The primary outcome measure is the Constant Score at 24 months post-operative. Secondary outcome measures include the American Shoulder and Elbow Surgeon's Score (ASES), EuroQol EQ-5D-5 L Health Questionnaire Score, short form PROMIS upper extremity score and IPAQ for the elderly score. Further outcome measures include assessment of the initial classification, displacement and angulation and the quality of surgical reduction via a standard computed tomography (CT) scan; rates of non-union, malunion, arthrosis, osteopenia or other complications including infection, nerve injury, intra-articular screw penetration, reoperation rates and hospital re-admission rates. DISCUSSION:The results of this trial will provide Level 1 evidence to guide decision-making in the treatment of proximal humerus fractures in the elderly population. TRIAL REGISTRATION:ClinicalTrials.gov NCT02362100 . Registered 5 Feb 2015.

Project description:Importance:Rotator cuff disorders remain the most common cause of shoulder pain and are among the most common reasons for patients to seek care in primary and specialty settings. Although operative and nonoperative treatments are offered to patients with atraumatic rotator cuff tears, there is a lack of evidence to support operative vs nonoperative treatment. This paucity of evidence has been highlighted by several professional agencies and experts. Objective:To perform a pragmatic randomized clinical trial, the Arthroscopic Rotator Cuff trial, comparing pain and functional outcomes in patients undergoing operative vs nonoperative treatment for atraumatic rotator cuff tears, and assessing heterogeneity of treatment effects by age and tear size. Design, Setting, and Participants:Trial protocol of the Arthroscopic Rotator Cuff trial. This pragmatic randomized clinical trial of an estimated 700 patients is adequately powered to accomplish its aims with 488 patients. Primary analysis will be conducted on an intent-to-treat population in the context of a mixed model. The multicenter trial started recruitment in 2018 with a 1-year follow-up duration. Patients aged 50 years or older to younger than 85 years with magnetic resonance imaging-confirmed atraumatic rotator cuff tears that are suitable for either operative or nonoperative treatment will be enrolled. Block randomization will be performed and stratified by site, age, and tear size. Intervention:Nonoperative treatment consists of an approximately 3-month standardized physical therapy program, whereas operative treatment consists of rotator cuff surgery followed by approximately 4 months of postoperative rehabilitation. Main Outcomes and Measures:The primary outcome is patient-reported Shoulder Pain and Disability Index score, and the secondary outcome is American Shoulder and Elbow Surgeons Standardized Shoulder Form score measured at 1 year of follow-up. Discussion:The Arthroscopic Rotator Cuff trial is ongoing, and 12 sites with more than 40 physicians are currently recruiting patients. Although there is variation by site, as of May 2, 2019, 13% of all patients screened (787 of 6293) were eligible for the trial, and 9% of eligible patients (74 of 787) were recruited. Results of this study may help patients, clinicians, and policy makers assess the comparative effectiveness of operative vs nonoperative treatment for atraumatic rotator cuff tears. Trial Registration:ClinicalTrials.gov identifier: NCT03295994.

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Selective episiotomy vs. implementation of a non episiotomy protocol: a randomized clinical trial.

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