Cervical Pessary versus Expectant Management for the Prevention of Delivery Prior to 36 Weeks in Women with Placenta Previa: A Randomized Controlled Trial

Objective This multicenter randomized controlled trial compared cervical pessary (CP) versus expectant management (EM) in women with placenta previa between 22.0 and 32.0 in prolonging gestation until ≥ 36.0 weeks' gestation. Study Design This study took place from November 2016 to June 2018. Women were randomized to receive either the Bioteque CP or EM. The pessary was removed at ≥ 36.0 weeks unless indicated. The primary outcome was gestational age (GA) at delivery, with secondary outcomes including need for transfusion, number and duration of antepartum admissions, type of delivery, and neonatal outcomes. A total of 140 patients were needed to show a 3-week prolongation of pregnancy in the pessary group; however, the trial was stopped early due to budgetary issues. Results Of the 33 eligible women, 17 were enrolled. Although not statistically significant, the mean GA at delivery in the CP group was greater than women in the EM group (36.5 ± 1.23 vs. 36.0 ± 2.0; p = 0.1673). The number and duration of antepartum admissions was greater in the EM group (2.7 ± 0.58 vs. 16.0 ± 22.76 days; p = 0.1264) as well. Conclusion Although the study was underpowered to determine the primary outcome, safety and feasibility of CP in pregnancies complicated with previa were demonstrated.

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Efficacy of acupuncture based on acupoint combination theory for irritable bowel syndrome: study protocol for a multicenter randomized controlled trial

10.21203/rs.3.rs-305564/v1 ◽

2021 ◽

Author(s):

Jing-wen Sun ◽

Zhi-gang Li ◽

Ming-liang Sun ◽

Da Li ◽

Jun Zhao ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Irritable Bowel Syndrome ◽

Social Adjustment ◽

Primary Outcome ◽

Controlled Trial ◽

Randomized Controlled ◽

Self Rating ◽

Multicenter Randomized Controlled Trial ◽

Secondary Outcomes ◽

Irritable Bowel

Abstract Background: Irritable bowel syndrome (IBS) is a chronic gastrointestinal disorder characterized by abdominal pain, diarrhea or constipation, and changes in defecation patterns. No organic disease has been found to explain these symptoms by routine clinical examination. This study aims to investigate the efficacy and safety of acupuncture therapy for IBS patients based on conventional treatments. We also want to explore the optimal acupoint combination recommended for IBS and clarify the clinical advantage of "multi-acupoint co-effect and synergistic effect".Methods and analysis: A total of 204 eligible patients who meet the Rome IV criteria for IBS will be randomly allocated to receive different acupuncture. Each patient will receive 12 acupuncture treatments over four weeks and will be followed up for four weeks. The primary outcome is the IBS-symptom severity score (IBS-SSS). The secondary outcomes include the Bristol stool form scale(BSFS), the work and social adjustment score (WSAS), the IBS-quality of life (IBS-QOL), self-rating anxiety scale (SAS), and the self-rating depression scale (SDS). Both the primary outcome and the secondary outcomes measures are collected at baseline, 2 weeks, and 4 weeks of the intervention, 6 weeks, and 8 weeks after the intervention.Ethics and dissemination: The entire project has been approved by the ethics committee of Beijing University of Chinese Medicine ( 2020BZYLL0903 ) .Discussion: This is a multicenter randomized controlled trial for IBS in China. This may shed light on the efficacy of acupuncture as an alternative to IBS. The results of the trial will be disseminated in peer-reviewed publications. Trial registration: Chinese Clinical Trials Register, ID: ChiCTR2000041215.First registered on 12 December 2020. http://www.chictr.org.cn/.

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Meropenem versus piperacillin-tazobactam for definitive treatment of bloodstream infections caused by AmpC beta-lactamase producing Enterobacter spp., Citrobacter freundii, Morganella morganii, Providencia spp., or Serratia marcescens: a pilot multi-center randomized controlled trial (MERINO-2)

Open Forum Infectious Diseases ◽

10.1093/ofid/ofab387 ◽

2021 ◽

Author(s):

Adam G Stewart ◽

David L Paterson ◽

Barnaby Young ◽

David C Lye ◽

Joshua S Davis ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Bloodstream Infection ◽

Primary Outcome ◽

Controlled Trial ◽

Risk Difference ◽

Definitive Treatment ◽

Beta Lactamase ◽

Suitable Alternative ◽

Randomized Controlled ◽

Multicenter Randomized Controlled Trial

Abstract Background Carbapenems are recommended treatment for serious infections caused AmpC-producing gram-negative bacteria but can select for carbapenem resistance. Piperacillin-tazobactam may be a suitable alternative. Methods We enrolled adult patients with bloodstream infection due to chromosomal AmpC-producers in a multicenter randomized controlled trial. Patients were assigned 1:1 to receive piperacillin-tazobactam 4.5 g every 6 hours or meropenem 1 g every 8 hours. The primary efficacy outcome was a composite of death, clinical failure, microbiological failure and microbiological relapse at 30 days. Results Seventy-two patients underwent randomization and were included in the primary analysis population. 11 of 38 patients (29%) randomized to piperacillin-tazobactam met the primary outcome compared with 7 of 34 patients (21%) in the meropenem group (risk difference, 8%, [95% CI –12% to 28%]). Effects were consistent in an analysis of the per-protocol population. Within the subcomponents of the primary outcome, 5 of 38 (13%) experienced microbiological failure in the piperacillin-tazobactam group compared to 0 of 34 patients (0%) in the meropenem group (risk difference, 13% [95% CI 2% to 24%]). In contrast, 0% versus 9% of microbiological relapses were seen in the piperacillin-tazobactam and meropenem arms, respectively. 96.5% and 100% were susceptible to piperacillin-tazobactam and meropenem, respectively using broth microdilution. The most common AmpC beta-lactamase genes identified were blaCMY-2, blaDHA-17, blaCMH-3 and blaACT-17. No ESBL, OXA or other carbapenemase genes were identified. Conclusion Among patients with bloodstream infection due to AmpC-producers, piperacillin-tazobactam may lead to more microbiological failures, although less microbiological relapses were seen.

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Effectiveness of at-home skin temperature monitoring in reducing the incidence of foot ulcer recurrence in people with diabetes: a multicenter randomized controlled trial (DIATEMP)

BMJ Open Diabetes Research & Care ◽

10.1136/bmjdrc-2021-002392 ◽

2021 ◽

Vol 9 (1) ◽

pp. e002392

Author(s):

Sicco A Bus ◽

Wouter B aan de Stegge ◽

Jeff G van Baal ◽

Tessa E Busch-Westbroek ◽

Frans Nollet ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Usual Care ◽

Primary Outcome ◽

Controlled Trial ◽

Foot Ulcer ◽

Ulcer Recurrence ◽

Ambulatory Activity ◽

Randomized Controlled ◽

Multicenter Randomized Controlled Trial ◽

At Home

IntroductionThe skin of people with diabetic foot disease is thought to heat up from ambulatory activity before it breaks down into ulceration. This allows for early recognition of imminent ulcers. We assessed whether at-home monitoring of plantar foot skin temperature can help prevent ulcer recurrence in diabetes.Research design and methodsIn this parallel-group outcome-assessor-blinded multicenter randomized controlled trial (7 hospitals, 4 podiatry practices), we randomly assigned people with diabetes, neuropathy, foot ulcer history (<4 years, n=295), or Charcot’s neuro-arthropathy (n=9) to usual care (ie, podiatric treatment, education, and therapeutic footwear) or usual care plus measuring skin temperatures at 6–8 plantar sites per foot each day (enhanced therapy). If ∆T>2.2°C between corresponding sites on the left and right foot for two consecutive days, participants were instructed to reduce ambulatory activity until this hotspot disappeared and contact their podiatrist. Primary outcome was ulcer recurrence in 18 months on the plantar foot, interdigital, or medial/lateral/anterior forefoot surfaces; secondary outcome was ulcer recurrence at any foot site.ResultsOn the basis of intention-to-treat, 44 of 151 (29.1%) participants in enhanced therapy and 57 of 153 (37.3%) in usual care had ulcer recurrence at a primary outcome site (RR: 0.782 (95%CI 0.566 to 1.080), p=0.133). Of the 83 participants in enhanced therapy who measured a hotspot, the 24 subsequently reducing their ambulatory activity had significantly fewer ulcer recurrences (n=3) than those in usual care (RR: 0.336 (95% CI 0.114 to 0.986), p=0.017). Enhanced therapy was effective over usual care for ulcer recurrence at any foot site (RR: 0.760 (95% CI 0.579 to 0.997), p=0.046).ConclusionsAt-home foot temperature monitoring does not significantly reduce incidence of diabetic foot ulcer recurrence at or adjacent to measurement sites over usual care, unless participants reduce ambulatory activity when hotspots are found, or when aiming to prevent ulcers at any foot site.Trial registration numberNTR5403.

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Leg-Length-Evening Device Improves Balance in Patients Wearing a Controlled Ankle Motion Boot: A Multicenter Randomized Controlled Trial

Foot & Ankle Orthopaedics ◽

10.1177/2473011420s00137 ◽

2020 ◽

Vol 5 (4) ◽

pp. 2473011420S0013

Author(s):

Daniel D. Bohl ◽

Nasima Mehraban ◽

Alexander J. Idarraga ◽

Kevin J. Wu ◽

Milap Patel ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Primary Outcome ◽

Controlled Trial ◽

Control Group ◽

Leg Length ◽

Ankle Motion ◽

Randomized Controlled ◽

Plantar Aspect ◽

Total Pain ◽

Multicenter Randomized Controlled Trial

Category: Other Introduction/Purpose: Patients are often made weight-bearing as tolerated (WBAT) in a controlled ankle motion (CAM) boot for the management of various foot and ankle conditions. The CAM boot causes a leg-length discrepancy (LLD) between the booted (longer) and contralateral (shorter) lower extremities. This discrepancy can potentially cause balance problems, undue strain on joints, and discomfort in patients. We hypothesized that a leg-length evening orthotic placed on the plantar aspect of the contralateral shoe improves balance among patients who are WBAT in a CAM boot. Methods: Patients made WBAT in a CAM boot were randomized to either the leg-length-evening orthotic intervention group or to a control group in which patients wore a normal shoe of their choice. Patients were followed for two weeks and asked a series of questions pertaining to balance and pain experienced at their knees, hips, and back. Balance was the primary outcome and was scored from 0 (no difficulty with balance) to 10 (great difficulty with balance). Results: Out of 107 subjects enrolled and randomized, 95 (88.8%) completed the study, satisfying the a priori sample size requirement of 94 patients. There were no differences in baseline characteristics between groups (p>0.05 for each). Intervention patients reported less difficulty with balance than control patients (intention-to-treat analysis: 2.0+-1.5 versus 3.2+-1.8, p=0.001; as-treated analysis: 2.1+-1.7 versus 3.0+-1.7, p=0.009). Intervention and control patients did not differ with respect to pain experienced at their knees, hips, or back, or in a composite total pain score (p>0.05 for each). Conclusion: This multicenter randomized controlled trial found that adding a limb-length-evening orthotic to the plantar aspect of the contralateral shoe in a patient that is WBAT in a CAM boot improves balance. The trial was powered to identify a difference in the primary outcome measure of balance and may have been insufficiently powered to identify differences in knee, hip, back, or total pain.

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Mother’s Bed Incline and Desaturation Episodes in Healthy Term Newborns during Early Skin-to-Skin Contact: A Multicenter Randomized Controlled Trial

Neonatology ◽

10.1159/000519387 ◽

2021 ◽

pp. 1-8

Author(s):

Jesús Rodríguez-López ◽

Javier De la Cruz Bértolo ◽

Nadia Raquel García-Lara ◽

José Luis Núñez Vecino ◽

María Soriano-Ramos ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Primary Outcome ◽

Respiratory Mechanics ◽

Controlled Trial ◽

Upright Position ◽

Randomized Controlled ◽

Skin Contact ◽

Multicenter Randomized Controlled Trial ◽

Term Newborns ◽

Skin To Skin

Introduction: Early skin-to-skin contact (ESSC) is associated with rare, sudden, unexpected postnatal collapse episodes. Placing the newborn in ESSC closer to an upright position may reduce the risk of airway obstruction and improve respiratory mechanics. This study assessed whether a greater inclination of the mother’s bed during ESSC would reduce the proportion of healthy term newborns (HTNs) who experienced episodes of pulse oximeter saturation (SpO2) <91%. Methods: We conducted a multicenter randomized controlled trial comparing the effect of the mother’s bed incline, 45° versus 15°, on desaturation in HTNs during ESSC. Before delivery on 1,271 dyads, randomization was conducted, and stringent criteria to select healthy mothers and term newborns were monitored until after birth. Preductal SpO2 was continuously monitored between 10 min and 2 h after birth. The primary outcome was the occurrence of at least one episode of SpO2 <91%. Results: 254 (20%) mother-infant dyads were eligible for analysis (45°, n = 126; 15°, n = 128). Overall, 57% (95% confidence interval [CI]: 51%–63%) of newborns showed episodes of SpO2 <91%. The proportion of infants with SpO2 <91% episodes was 52% in 45° and 62% in 15° (relative risk: 0.80; 95% CI: 0.6–1.07). Conclusions: We did not show that a high mother bed inclination during ESSC led to significantly fewer HTNs who experienced episodes of SpO2 <91%. Desaturation episodes from 10 min to 2 h after birth occurred in more than half of HTNs.

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Efficacy of acupuncture based on acupoint combination theory for irritable bowel syndrome: a study protocol for a multicenter randomized controlled trial

Trials ◽

10.1186/s13063-021-05432-0 ◽

2021 ◽

Vol 22 (1) ◽

Author(s):

Jing-wen Sun ◽

Ming-liang Sun ◽

Da Li ◽

Jun Zhao ◽

Su-hua Shi ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Primary Outcome ◽

Controlled Trial ◽

Control Group ◽

Randomized Controlled ◽

Multicenter Randomized Controlled Trial ◽

Group A ◽

Irritable Bowel ◽

Group B ◽

Experimental Group

Abstract Background Irritable bowel syndrome (IBS) is a chronic gastrointestinal disorder characterized by abdominal pain, diarrhea or constipation, and changes in defecation patterns. No organic disease is found to explain these symptoms by routine clinical examination. This study aims to investigate the efficacy and safety of acupuncture therapy for IBS patients compared with those of conventional treatments. We also aim to identify the optimal acupoint combination recommended for IBS and to clarify the clinical advantage of the “multiacupoint co-effect and synergistic effect.” Methods and analysis A total of 204 eligible patients who meet the Rome IV criteria for IBS will be randomly stratified into acupuncture group A, acupuncture group B, or the control group in a 1:1:1 ratio with a central web-based randomization system. The prespecified acupoints used in the control group will include bilateral Tianshu (ST25), Shangjuxu (ST37), Neiguan (PC6), and Zusanli (ST36). The prespecified acupoints used in experimental group A will include bilateral Tianshu (ST25), Shangjuxu (ST37), and Neiguan (PC6). The prespecified acupoints used in experimental group B will include bilateral Tianshu (ST25), Shangjuxu (ST37), and Zusanli (ST36). Each patient will receive 12 acupuncture treatments over 4 weeks and will be followed up for 4 weeks. The primary outcome is the IBS-Symptom Severity Scale (IBS-SSS) score. The secondary outcomes include the Bristol Stool Form Scale (BSFS), Work and Social Adjustment Score (WSAS), IBS-Quality of Life (IBS-QOL), Self-Rating Anxiety Scale (SAS), and Self-Rating Depression Scale (SDS) scores. Both the primary outcome and the secondary outcome measures will be collected at baseline, at 2 and 4 weeks during the intervention, and at 6 weeks and 8 weeks after the intervention. Ethics and dissemination The entire project has been approved by the ethics committee of the Beijing University of Chinese Medicine (2020BZYLL0903). Discussion This is a multicenter randomized controlled trial for IBS in China. The findings may shed light on the efficacy of acupuncture as an alternative to conventional IBS treatment. The results of the trial will be disseminated in peer-reviewed publications. Trial registration Chinese Clinical Trials Register ChiCTR2000041215. First registered on 12 December 2020. http://www.chictr.org.cn/.

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Helmet noninvasive ventilation for COVID-19 patients (Helmet-COVID): study protocol for a multicenter randomized controlled trial

10.1101/2021.08.04.21260420 ◽

2021 ◽

Author(s):

Yaseen Arabi ◽

Haytham Tlayjeh ◽

Sara Aldekhyl ◽

Hasan Al-Dorzi ◽

Sheryl Ann Abdukahil ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Usual Care ◽

Noninvasive Ventilation ◽

Primary Outcome ◽

Controlled Trial ◽

Institutional Review Boards ◽

Hypoxemic Respiratory Failure ◽

Acute Hypoxemic Respiratory Failure ◽

Randomized Controlled ◽

Multicenter Randomized Controlled Trial

Introduction Noninvasive ventilation delivered by helmet is has been used for respiratory support of patients with acute hypoxemic respiratory failure due to COVID-19 pneumonia. The aim of this study is to compare helmet noninvasive ventilation with usual care versus usual care alone to reduce the mortality. Methods and analysis This is a multicenter, pragmatic, parallel, randomized controlled trial that compares helmet noninvasive ventilation with usual care to usual care alone in 1:1 ratio. A total of 320 patients will be enrolled in this study. The primary outcome is 28-day all-cause mortality. The primary outcome will be compared between the two study groups in the intention-to-treat and per-protocol cohorts. An interim analysis will be conducted for both safety and effectiveness. Ethics and dissemination Approvals are obtained from the Institutional Review Boards (IRBs) of each participating institution. Our findings will be published in peer-review journals and presented at relevant conferences and meetings.

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