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Results for “randomized controlled trial (RCT)”

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PubMedDate not supplied

Supporting medication adherence in renal transplantation (SMART): a pilot RCT to improve adherence to immunosuppressive regimens.

BACKGROUND: Although non-adherence to an immunosuppressive regimen (NAH) is a major risk factor for poor outcome after renal transplantation (RTx), very few studies have examined non-adherence intervention in this context. This pilot randomized controlled trial (RCT) tested the efficacy of an educational-behavioural intervention to increase adherence in non-adherent RTx patients. We also assessed how NAH evolves over time. METHODS: Eighteen RTx non-adherent patients (age: 45.6 +/- 1.2 yr; 78.6% male) were randomly assigned to either an intervention group (IG) (n = 6) or an enhanced usual care group (EUCG) (n = 12), the latter receiving the usual clinical care. The IG received one home visit and three telephone interviews. We assessed NAH through electronic monitoring (EM) of medication intake during a nine-month period (three months intervention, six months follow-up). RESULTS: Five of 18 patients withdrew. Inclusion in the study resulted in a remarkable decrease in NAH in both groups over the first three months (IG chi(2) = 3.97, df = 1, p = 0.04; EUCG chi(2) = 3.40, df = 1, p = 0.06). The IG showed the greatest decrease in NAH after three months, although this did not reach statistical significance (at 90 d, chi(2) = 1.05, df = 1, p = 0.31). Thereafter, NAH increased gradually in both groups, reaching comparable levels at the end of the six-month follow-up (i.e. at nine months). CONCLUSION: Our findings suggest an inclusion effect. Although the intervention in this pilot RCT appeared to add further benefit in medication compliance, a lack of statistical power prevented us from making a strong statistical statement.

Adolescent↗

PubMed2001

Conducting randomized, controlled trials. Experience with the dysfunctional uterine bleeding intervention trial.

OBJECTIVE: To conduct a randomized, controlled trial (RCT) to examine issues associated with therapeutic alternatives to standard hysterectomy for women with dysfunctional uterine bleeding. STUDY DESIGN: Participants were to be randomly assigned to one of three treatment groups: hysterectomy, endometrial ablation and medical management. Recruitment was targeted at 375 women. RESULTS: Despite multiple recruitment strategies, recruitment was weak, with only five women enrolled after six months. Providers and women screened for eligibility often expressed discomfort with randomization. The protocol was amended to an elective treatment cohort design with a randomization component. Recruitment improved, with 37 women enrolled after four months. CONCLUSION: The success of RCTs may be affected by multiple factors. Acceptance of the protocol by patients and providers is essential. The RCT may present providers with a conflict between the goals of research and of providing optimal individualized care. Thus, RCTs may not always be appropriate for studies designed to examine best treatments in clinical practice, and nonrandomized designs may provide appropriate alternatives in some cases.

Clinical Protocols↗

PubMed2006

Outcome data from the LEAP (Live, Eat and Play) trial: a randomized controlled trial of a primary care intervention for childhood overweight/mild obesity.

OBJECTIVES: To reduce gain in body mass index (BMI) in overweight/mildly obese children in the primary care setting. DESIGN: Randomized controlled trial (RCT) nested within a baseline cross-sectional BMI survey. SETTING: Twenty nine general practices, Melbourne, Australia. PARTICIPANTS: (1) BMI survey: 2112 children visiting their general practitioner (GP) April-December 2002; (2) RCT: individually randomized overweight/mildly obese (BMI z-score <3.0) children aged 5 years 0 months-9 years 11 months (82 intervention, 81 control). INTERVENTION: Four standard GP consultations over 12 weeks, targeting change in nutrition, physical activity and sedentary behaviour, supported by purpose-designed family materials. MAIN OUTCOME MEASURES: Primary: BMI at 9 and 15 months post-randomization. Secondary: Parent-reported child nutrition, physical activity and health status; child-reported health status, body satisfaction and appearance/self-worth. RESULTS: Attrition was 10%. The adjusted mean difference (intervention-control) in BMI was -0.2 kg/m(2) (95% CI: -0.6 to 0.1; P=0.25) at 9 months and -0.0 kg/m(2) (95% CI: -0.5 to 0.5; P=1.00) at 15 months. There was a relative improvement in nutrition scores in the intervention arm at both 9 and 15 months. There was weak evidence of an increase in daily physical activity in the intervention arm. Health status and body image were similar in the trial arms. CONCLUSIONS: This intervention did not result in a sustained BMI reduction, despite the improvement in parent-reported nutrition. Brief individualized solution-focused approaches may not be an effective approach to childhood overweight. Alternatively, this intervention may not have been intensive enough or the GP training may have been insufficient; however, increasing either would have significant cost and resource implications at a population level.

Body Image↗

PubMed2026

Assessment of the role and effectiveness of nurse-led multimodal intervention in the rehabilitation of dysphagia in patients with brain tumors.

BACKGROUND: Dysphagia is a common complication in patients with brain tumors, which has a profound adverse impact on patients' health status and quality of life. However, there is a relative lack of research on the rehabilitation of dysphagia in brain tumor patients, especially regarding the role and effectiveness of nurse-led multimodal interventions in the rehabilitation of dysphagia in brain tumor patients, which lacks systematic assessment and in-depth discussion. AIM: This study aimed to evaluate the role and effectiveness of a nurse-led multimodal intervention in improving swallowing function and quality of life in brain tumor patients with dysphagia. METHODS: In this study, a randomized controlled trial (RCT) design was used to select 120 dysphagia patients among brain tumor patients admitted to our hospital during the period of January 2024 to May 2024 as the study subjects, and they were stratified and randomly divided into an intervention group (n = 60) and a control group (n = 60). While the control group received conventional nursing care and treatment protocols, the intervention group received a nurse-led multimodal intervention program, including personalized swallowing training, nutritional support, psychological care, and a family-participatory rehabilitation program, which was developed and dynamically adjusted by nurses, rehabilitation therapists, and dietitians. Differences in data before and after the intervention were analyzed using the paired t-test or Wilcoxon signed-rank test, and between-group comparisons were made using the independent samples t-test or Mann-Whitney U test. RESULTS: Both the intervention and control groups showed improvement in swallowing function among the patients. The Kubota drinking test score, Saito's swallowing function grading, and the quality of life scores for patients in the intervention group showed a significant enhancement compared to those in the control group (P < 0.05), indicating that the intervention was more effective than the control. When compared within groups, all scores in both the intervention and control groups improved gradually with the time of intervention (P < 0.05). The improvement was significantly higher in the intervention group than in the control group. CONCLUSION: This study demonstrates that a nurse-led multimodal intervention is significantly effective in improving swallowing function and quality of life in patients with brain tumors. The intervention provides comprehensive rehabilitation support for patients through multidisciplinary collaboration and personalized care and has certain clinical promotion value.

Humans↗

PubMed2003

A pilot study into the use of a multisensory environment (Snoezelen) within a palliative day-care setting.

Sensory environments may potentially provide an atmosphere of calm and refreshment. This small pilot study used a randomized controlled trial (RCT) design and semi-structured interviews to investigate the use of the Snoezelen multisensory environment in palliative day care. Its second aim was to explore the feasibility of the RCT design in advance of a possible larger trial. The study compared Snoezelen with a normal 'quiet room' setting. Following screening for anxiety, 26 patients were recruited and randomly assigned to the control of experimental group. Anxiety and depression were assessed using the Hospital Anxiety and Depression scale and quality of life assessed using the European Organisation for Research and Treatment of Cancer Core 30 questionnaire. A significant reduction in anxiety was seen with the experimental group (P=0.01) but no changes were observed in any of the quality-of-life subscales. However, the results should be viewed with caution, as there were some differences between the groups in two of the quality-of-life subscales. Data from semi-structured interviews suggested Snoezelen might promote relaxation. It is concluded that Snoezelen is feasible for use with this patient group and recommendations are made for further research.

Aged↗

PubMed2005

Training professionals to engage with and promote self-management.

We have set out to investigate an approach to improve patients' ability to self-manage chronic illness. For effective health care in chronic disease, we believe patients need to work in partnership with their doctor; patient-centred consultations are one way to achieve this. This report describes our experience of training specialists in gastroenterology to consult in a patient-centred style as part of a complex self-management intervention in a randomized controlled trial (RCT) involving 700 patients with established inflammatory bowel disease (IBD) attending outpatient clinics. The training session aimed to provide specialists from nine randomly selected intervention sites with the basic skills to carry out the intervention. The training lasted 2 hours, and included background on the research and intervention, a demonstration video, role-play, and video-feedback training. The main findings of the RCT are presented (service use, enablement and satisfaction), and discussed in the light of the views of consultants and patients on the experience of putting the training into practice. The findings of our study confirm and highlight the value of training in patient-centred communication and its potential for promoting self-management effects; the training proved effective in enabling consultants in gastroenterology to establish guided self-management in patients with IBD.

Adolescent↗

PubMed2026

Effects of Digital Mental Health Screening Alone and With the Online MINDBODYSTRONG CBT-Based Program on Burnout, Depression, Anxiety, Healthy Behaviors, and Suicidal Ideation in at-Risk Nurses at 3- and 6-Months Post-Intervention: An RCT.

BACKGROUND: Burnout and mental distress among nurses are global public health epidemics that adversely affect nurse well-being and healthcare quality. Evidence-based, scalable mental health interventions are urgently needed. AIMS: To evaluate the 3- and 6-month outcomes of a randomized controlled trial (RCT) comparing a psychologically safe, digital mental health screening and referral program alone versus the same screening and referral program combined with the video-based online MINDBODYSTRONG (MBS) cognitive behavioral therapy (CBT)-based skills-building program among nurses at risk for mental distress. METHODS: 501 nurses were recruited from professional organizations and healthcare systems across the United States by email and randomized to either mental health screening and referral (standard care) or standard care plus the MBS cognitive behavioral skills-building intervention (the intervention). All study activities were conducted remotely. Follow-up surveys administered at 3- and 6-months assessed anxiety, depression, suicidal ideation, burnout, healthy lifestyle beliefs, and healthy lifestyle behaviors using valid and reliable scales. RESULTS: Compared with the screening and referral only group, participants in the intervention group had greater reductions in anxiety and depression and significantly greater increases in healthy lifestyle beliefs and behaviors at 3 and 6 months post-intervention. After controlling baseline risk, the intervention group had a lower risk of suicidal ideation than the screening and referral group at 3 months (relative risk ratio [RRR] = 0.717; 95% CI: 0.320-1.606) and 6 months (RRR = 0.329; 95% CI: 0.101-1.072). The intervention group also had a significantly lower risk of burnout at 6 months (RRR: 0.698, 95% CI: 0.528, 0.929, p = 0.012). Nurses who completed more MBS sessions had less suicidal ideation at 6 months and those who completed more MBS skills-building activities had less burnout at 3 and 6 months. LINKING ACTION TO EVIDENCE: Integrating psychologically safe mental health screening combined with the scalable online CBT-based intervention, MBS, can produce sustained improvements in burnout, mental health symptoms, including suicidality, and healthy lifestyle beliefs and behaviors among nurses experiencing mental distress.

Humans↗

PubMed2005

Bibliometric analysis of the literature of randomized controlled trials.

OBJECTIVE: Evidence-based medicine (EBM) is a significant issue and the randomized controlled trial (RCT) literature plays a fundamental role in developing EBM. This study investigates the features of RCT literature based on bibliometric methods. Growth of the literature, publication types, languages, publication countries, and research subjects are addressed. The distribution of journal articles was also examined utilizing Bradford's law and Bradford-Zipf's law. METHOD: The MEDLINE database was searched for articles indexed under the publication type "Randomized Control Trial," and articles retrieved were counted and analyzed using Microsoft Access, Microsoft Excel, and PERL. RESULTS: From 1990 to 2001, a total of 114,850 citations dealing with RCTs were retrieved. The literature growth rate, from 1965 to 2001, is steadily rising and follows an exponential model. Journal articles are the predominant form of publication, and the multicenter study is extensively used. English is the most commonly used language. CONCLUSIONS: Generally, RCTs are found in publications concentrating on cardiovascular disease, cancer, asthma, postoperative condition, health, and anesthetics. Zone analysis and graphical formulation from Bradford's law of scattering shows variations from the standard Bradford model. Forty-two core journals were identified using Bradford's law.

Bibliometrics↗

PubMed2003

Tamsulosin: efficacy and safety in patients with neurogenic lower urinary tract dysfunction due to suprasacral spinal cord injury.

PURPOSE: We evaluated the efficacy and safety of tamsulosin in patients with neurogenic lower urinary tract dysfunction secondary to suprasacral spinal cord lesions in a 4-week randomized controlled trial (RCT) followed by a 1-year, open label, long-term study. MATERIALS AND METHODS: A total of 263 patients were randomized to 4-week double-blind therapy with placebo, or 0.4 or 0.8 mg tamsulosin once daily. Of these, 244 patients completed the RCT, 186 continued long-term tamsulosin therapy (0.4 or 0.8 mg once daily) and 134 completed 1-year treatment. The primary efficacy parameter was maximum urethral pressure (MUP). RESULTS: Although the mean decrease in MUP at 4 weeks in the RCT did not reach statistical significance over the placebo, it was more pronounced with 0.4 (-12.2 cm H2O or -10%) and 0.8 mg (-9.6 cm H2O or -9%) tamsulosin than placebo (-6.5 cm H2O or -3%). In the long-term study there was a statistically significant mean decrease in MUP (-18.0 cm H2O, p <0.001 or -15%) from baseline to end point. In the long-term study tamsulosin also decreased maximum urethral closure pressure, improved several cystometry parameters related to bladder storage and emptying, and increased to a statistically significantly degree, from baseline to end point, mean voided volume based on the micturition diary. There was statistically significant improvement for the International Prostate Symptom Score Quality of Life, as well as several questions about symptoms related to urinary leakage, and 1 question on bladder emptying and frequency, bother and severity of symptoms of autonomic dysreflexia. Finally, 71% of patients improved according to investigators (44% slightly and 27% much improved). Both doses were effective and well tolerated. CONCLUSIONS: Long-term tamsulosin treatment (0.4 and 0.8 mg once daily) seems to be effective and well tolerated in patients with neurogenic lower urinary tract dysfunction. The results suggest that it improves bladder storage and emptying, and decreases symptoms of autonomic dysreflexia.

Adolescent↗

PubMed2003

Current status of intrapartum fetal monitoring: cardiotocography versus cardiotocography + ST analysis of the fetal ECG.

Two randomized controlled trials (RCT) on intrapartum fetal monitoring with cardiotocography (CTG) only versus CTG combined with automatic ST segment waveform analysis of the fetal ECG have been performed. In altogether 6826 randomized cases, the odds ratio for operative delivery for fetal distress (ODFD) was 0.65 (95% confidence interval 0.53-0.78) and for metabolic acidosis at birth 0.39 (0.21-0.72), in favor of the CTG+ST method. CTG combined with ST analysis increases the ability of obstetricians to identify fetal hypoxia and to intervene more appropriately, resulting in an improved perinatal outcome.

Cardiotocography↗

PubMed2002

Does acupuncture have additional value to standard poststroke motor rehabilitation?

BACKGROUND AND PURPOSE: A significant number of patients remain severely disabled after stroke despite rehabilitation with standard treatment modalities. Acupuncture has been reported as an alternative modality. This study aims to examine whether acupuncture has additional value to standard poststroke motor rehabilitation. METHODS: A prospective randomized controlled trial (RCT) was carried out in a stroke rehabilitation unit in Hong Kong. One hundred six Chinese patients with moderate or severe functional impairment were included at days 3 to 15 after acute stroke. They were stratified into the moderate and the severe groups before randomization into the control arm receiving standard modalities of treatment, which included physiotherapy, occupational and speech therapy, and skilled medical and nursing care, and the intervention arm receiving in addition traditional Chinese manual acupuncture. A mean of 35 acupuncture sessions on 10 main acupoints were performed over a 10-week period. Outcome measures included Fugl-Meyer assessment, Barthel Index, and Functional Independence Measure, respectively, at weeks 0, 5, and 10, performed by blinded assessors. RESULTS: At baseline, patients in each arm were comparable in all important prognostic characteristics. No statistically significant differences were observed between the 2 arms for any of the outcome measures at week 10 or outcome changes over time. CONCLUSIONS: Traditional Chinese manual acupuncture on the body has no additional value to standard poststroke motor rehabilitation.

Acupuncture Therapy↗

PubMed2003

The influence of gestational age on the efficacy and short-term safety of sucrose for procedural pain relief.

BACKGROUND: Physiologic and behavioral responses to procedural pain are influenced by gestational age (GA). Compared with term neonates, hospitalized preterm neonates are subjected to more painful procedures aimed at improving their clinical outcome. Although several trials to determine the efficacy of sucrose for managing procedural pain have been conducted, none have examined the influence of GA. OBJECTIVES: To examine the influence of GA on the efficacy and short-term safety of oral sucrose for relieving procedural pain associated with heel lances. To explore GA differences in behavioral and physiologic indicators of pain. METHODS: As part of a larger randomized controlled trial (RCT) to examine the efficacy and safety of sucrose during heel lance, 190 neonates were stratified by GA: (a) 27 to 316/7 weeks (group 1; n = 63), (b) 32 to 356/7 weeks (group 2; n = 63), and (c) >36 weeks (group 3; n = 64). They were then randomized to receive (a) oral sucrose and non-nutritive sucking (NNS), (b) sucrose alone, or (c) sterile water and NNS (control) for a heel lance. The influence of GA was determined by examining the short-term safety, as defined by the number of associated adverse events (choking, coughing or vomiting, sustained tachycardia, sustained tachypnea or dyspnea, or sustained oxygen desaturation). The efficacy was measured by changes in a validated pain measure, scored during each phase of the intervention and analyzed according to GA groups. RESULTS: Significant differences in pain response existed in each GA group, with the lowest mean pain scores in the sucrose and NNS group. Significant GA differences in behavioral and physiologic responses were found, with the most mature neonates demonstrating the greatest magnitude of pain response. The greatest number of short-term adverse effects to treatment occurred in the lowest GA group. CONCLUSIONS: In a secondary analysis of a larger RCT, sucrose and NNS was the most efficacious intervention for single heel lances in each of 3 GA groups. However, infants of lower GA experienced more adverse events. Research on the efficacy and safety of repeated doses of oral sucrose, tested in infants from a wide range of GA, is required.

Analysis of Variance↗

PubMed2004

A multicentre randomized controlled trial of expectant management versus IVF in women with Fallopian tube patency.

BACKGROUND: Although observational studies suggest that IVF is more effective than no treatment for women with Fallopian tube patency, this has not been tested rigorously in a randomized controlled trial (RCT). METHODS: Eligible consenting couples planning their first treatment cycle in five Canadian fertility clinics received either IVF, within 90 days of randomization, or a period of 90 days with no treatment. Random allocation was stratified by female age and sperm quality, and administered using numbered, opaque, sealed envelopes. Follow-up assessed live birth and associated morbidity. RESULTS: Sixty-eight couples were randomized to a first cycle of IVF and 71 couples had 3 months without treatment. The live birth rates were 20/68 (29%) and 1/71 (1%), respectively. The single delivery in the untreated group was of twins, as were six of the 20 IVF deliveries (30%). An average of 2.0 embryos were transferred and no triplet pregnancies resulted. The relative likelihood of delivery after allocation to IVF was 20.9-fold higher than after allocation to no treatment [95% confidence interval (CI) 2.8-155]. The presence of abnormal sperm did not reduce this likelihood. Treating four women (95% CI 3-6) with one cycle of IVF is required to achieve a single additional birth. CONCLUSIONS: This study provides a valid and up-to-date comparison for policy makers and patients as they make choices around IVF, accurately measuring and confirming a major benefit from treatment.

Birth Rate↗

PubMed2004

[Gastric cancer: laparoscopic surgery and adjuvant chemotherapy].

Demands for minimally invasive treatments for early gastric cancer and improved efficacy of recent chemotherapy regimens for advanced gastric cancer have led to considerable changes in the modality of treatment Laparoscopic gastrectomy (LG) with lymph node dissection is widely performed as minimally invasive surgery. The number of LGs is increasing each year. However, the results of a nationwide questionnaire survey performed by the Japanese Society for Endoscopic Surgery indicated that there are some postoperative complications associated with gastrointestinal anastomosis. In this paper, we describe our experiences with a unique intracorporeal surgical technique to prevent such complications. Although adjuvant chemotherapy is frequently administered to patients with advanced gastric cancer, no randomized controlled trial (RCT) has confirmed the prognostic significance of adjuvant chemotherapy, although some meta-analyses have. Since a number of published reports demonstrated the survival benefit of chemosensitivity test-guided chemotherapy after surgery for gastric cancer, we propose a protocol to perform a RCT to clarify whether chemosensitivity tests in adjuvant chemotherapy for gastric cancer have a significant impact.

Chemotherapy, Adjuvant↗

PubMed2006

A randomized controlled trial of implant-retained mandibular overdentures.

Evidence from randomized clinical trials of implant-retained overdentures is very limited at the present time. The aim of this study was to compare implant-retained mandibular overdentures and conventional complete dentures in a randomized controlled trial (RCT). Our a priori hypothesis was that implant-retained mandibular overdentures would be significantly better than conventional complete dentures. Edentulous patients (n = 118) were randomly allocated to either an Implant Group (n = 62) or a Denture Group (n = 56). Patients completed the Oral Health Impact Profile (OHIP) and a denture satisfaction scale pre-treatment and three months post-treatment. Upon completion of treatment, both groups reported improvement (p < 0.001, Wilcoxon Ranks Sum test) in oral-health-related quality of life and denture satisfaction. There were no significant post-treatment differences between the groups, but a treatment effect may be masked by application of "intention to treat" analysis. The OHIP change scores were significantly greater for patients receiving implants than for those who refused them.

Age Factors↗

PubMed2000

Using health production functions to evaluate treatment effectiveness: an application to a community mental health service.

The randomized controlled trial (RCT) is the recommended means of evaluating health care effectiveness and cost-effectiveness. Whilst representing a 'gold-standard' in health services research, RCT evidence on the clinical and economic desirability of services and treatments is often absent. Where RCT evidence is lacking, or where it is infeasible to implement randomized controlled comparisons, longitudinal observational and naturalistic data sources when analysed appropriately can yield useful insights regarding the clinical effectiveness and economic efficiency of treatments. In this paper we demonstrate the utility of applying panel estimation methods to data from an Italian psychiatric case register as a means of modelling the mental health outcomes of patients referred to a community-based mental health service. Emphasis is placed on quantifying the clinical effectiveness of consultations with different mental health professionals (including in-patient days) and whether service outcomes are affected by psychiatric diagnosis. The impact of service consultations and their interaction with different types of psychiatric diagnosis on a measure of patient mental health are found to be statistically significant, although the size of these effects are not substantial from a clinical perspective.

Adult↗

PubMed2026

Application of SPI-guided analgesia in laparoscopic gynecologic surgery: a randomized controlled trial evaluating the remifentanil-sparing effect and predictive value of time-weighted SPI.

This study aimed to achieve two primary objectives: (1) to evaluate the opioid-sparing effect of Surgical Pleth Index (SPI)-directed analgesia during surgery via a randomized controlled trial (RCT), and (2) to propose and preliminarily assess a novel dynamic metric, Threshold-based Time-Weighted SPI (Tb-TW-SPI), which integrates stimulus intensity and duration, for its predictive efficacy regarding postoperative moderate-to-severe pain. Employing an RCT combined with exploratory analysis, 61 patients undergoing elective laparoscopic gynecologic surgery were randomized into an SPI-directed analgesia group or a conventional analgesia group. The primary outcome was total intraoperative remifentanil consumption. Postoperatively, an exploratory analysis of the control group data evaluated the correlation between Tb-TW-SPI and Numeric Rating Scale (NRS) pain scores in the post-anesthesia care unit (PACU), calculating its predictive value for moderate-to-severe pain (NRS ≥ 4). Results: The SPI-directed group required significantly less intraoperative remifentanil than the conventional group [median (IQR): 5.84(5.02,6.62)vs. 6.96(5.81,8.19)µg/kg/h; P = 0.016]. Postoperative pain scores did not differ significantly between groups (P > 0.05). Exploratory analysis of the conventional analgesia group revealed that Tb-TW-SPI values were significantly higher in patients with moderate-to-severe postoperative pain (NRS ≥ 4) compared to those without (P = 0.0417).The area under the ROC curve for Tb-TW-SPI predicting this pain was 0.74 (95% CI: 0.52-0.96), with 67% sensitivity and 76% specificity at an optimal cutoff of 1210. This RCT suggests that SPI-directed analgesia can safely and moderately reduce intraoperative remifentanil consumption. Furthermore, the proposed Tb-TW-SPI metric, in this exploratory analysis, suggests potential for predicting postoperative pain, though this finding requires validation in larger cohorts with higher-frequency SPI sampling, offering a new direction for SPI interpretation. Large-scale, multicenter trials are warranted to validate the predictive utility of Tb-TW-SPI. Clinical Trial Registration, China Clinical Trial Registry: ChiCTR2400088444.

Humans↗

PubMed1992

Does episiotomy prevent perineal trauma and pelvic floor relaxation?

OBJECTIVE: To compare the outcomes of the current practice of liberally or routinely employing episiotomy to prevent perineal tears and pelvic floor relaxation (control group) to a policy of restricting episiotomy use to specific fetal and maternal indications (experimental group). DESIGN: A randomized controlled trial (RCT). SETTING: Three university hospitals in Montreal. SUBJECTS: Seven hundred three low-risk women enrolled at 30 to 34 weeks of gestation were randomized late in labor to the designated trial arm, by parity, and followed up to 3 months postpartum. MAIN OUTCOME MEASURES: Antepartum and postpartum information on perineal trauma and pain, pelvic floor symptoms (urinary incontinence), and sexual activity was collected through the use of standard questionnaires; pelvic floor function was measured by electromyographic (EMG) perineometry. RESULTS: Restricting episiotomy use in primiparous women was associated with similar sutured perineal trauma to the liberal or routine approach. Multiparous women in the restricted episiotomy group more often gave birth with an intact perineum (31% compared with 19%, odds ratio (OR) = 1.85, 95% confidence interval (CI) = 1.09 to 3.16). All but one 3rd/4th-degree perineal tear was associated with median episiotomy (46 of 47 in primiparous women and 6 of 6 among multiparous women). No difference between trial groups was found in postpartum perineal pain, antepartum and 3-month postpartum EMG perineometry, and urinary and pelvic floor symptoms. CONCLUSIONS: We found no evidence that liberal or routine use of episiotomy prevents perineal trauma or pelvic floor relaxation. Virtually all severe perineal trauma was associated with median episiotomy. Restriction of episiotomy use among multiparous women resulted in significantly more intact perineums and less perineal suturing.

Adult↗