scholarly journals Comparison of two caries prevention programs among Thai kindergarten: a randomized controlled trial

2020 ◽  
Author(s):  
Pagaporn Pantuwadee Pisarnturakit ◽  
Palinee Detsomboonrat
Keyword(s):  
High Risk ◽  
Controlled Trial ◽  
Low Risk ◽  
Kindergarten Children ◽  
Primary Molar ◽  
Permanent Molar ◽  
Carious Lesions ◽  
Caries Increment ◽  
Risk Approach ◽  
Clinical Trials Registry

Abstract Background: Intensified preventive regimen based on a ‘high-risk’ approach has been proposed instead the routine prevention that is generally given to the whole population. The effectiveness of these regimens may still be an issue. Therefore, the aim of this study was to compare two preventive programs carried out in a Public School for kindergarten children. Methods: The data from clinical examinations were used to assess the caries risk for 121 children. Children with at least 2 carious lesions were considered as high risk for dental caries development. These children were randomized into two groups. Half (High risk basic-HRB group) were provided the basic prevention regimen (oral-hygiene instruction and hands-on brushing practice for teachers and caregivers, daytime tooth brushing supervised by teachers at least once a week, newly erupted first permanent molar sealant, provision of toothbrush, fluoride-containing dentifrice, and a guidebook), which was also given to low-risk children (Low risk basic-LRB group). The other half (High risk intensive-HRI group) were additionally given an intensified preventive regimen (F-varnish application, primary molar sealant, and silver diamine fluoride (SDF) application on carious lesions). Clinical examinations were performed semiannually to determine the dmfs caries increment of the three groups. Results: The 89 children completed the 24-month examination were 3- to 5-year-old with 19, 35, and 35 children in the LRB, HRB, and HRI group, respectively. The new caries development at 24 months of the HRB group (75%) was higher than that of the HRI group (65.7%) and the LRB group (21.1%). One-way analysis of variance (ANOVA) indicated no significant differences of caries increment between the HRB and HRI groups at the end of our study ( p =0.709). Conclusions: The negligible difference in caries increment between the HRI and HRB groups implies that intensified prevention produced minimal additional benefit. Offering all children only basic prevention could have obtained virtually the same preventive effect with substantially less effort and lower cost. Trial registration: Thai Clinical Trials Registry (TCTR), TCTR20180124001. Registered 24 January 2018 - Retrospectively registered, https://www.clinicaltrials.in.th/TCTR20180124001.

scholarly journals Comparison of two caries prevention programs among Thai kindergarten: a randomized controlled trial

2020 ◽  
Author(s):  
Pagaporn Pantuwadee Pisarnturakit ◽  
Palinee Detsomboonrat
Keyword(s):  
High Risk ◽  
Controlled Trial ◽  
Low Risk ◽  
Kindergarten Children ◽  
Primary Molar ◽  
Permanent Molar ◽  
Carious Lesions ◽  
Caries Increment ◽  
Risk Approach ◽  
Oral Hygiene Instruction

Abstract Background: Intensified preventive regimen based on a ‘high-risk’ approach has been proposed instead the routine prevention that is generally given to the whole population. The effectiveness of these regimens may still be an issue. Therefore, the aim of this study was to compare two preventive programs carried out in a Public School for kindergarten children. Methods: The data from clinical examinations were used to assess the caries risk for 121 children. Children with at least 2 carious lesions were considered as high risk for dental caries development. These children were randomized into two groups. Half (High risk basic-HRB group) were provided the basic prevention regimen (oral-hygiene instruction and hands-on brushing practice for teachers and caregivers, daytime tooth brushing supervised by teachers at least once a week, newly erupted first permanent molar sealant, provision of toothbrush, fluoride-containing dentifrice, and a guidebook), which was also given to low-risk children (Low risk basic-LRB group). The other half (High risk intensive-HRI group) were additionally given an intensified preventive regimen (F-varnish application, primary molar sealant, and silver diamine fluoride (SDF) application on carious lesions). Clinical examinations were performed semiannually to determine the dmfs caries increment of the three groups. Results: The 89 children completed the 24-month examination were 3- to 5-year-old with 19, 35, and 35 children in the LRB, HRB, and HRI group, respectively. The new caries development at 24 months of the HRB group (75%) was higher than that of the HRI group (65.7%) and the LRB group (21.1%). One-way analysis of variance (ANOVA) indicated no significant differences of caries increment between the HRB and HRI groups in caries increment at the end of our study (p=0.709). Conclusions: The negligible difference in caries increment between the HRI and HRB groups implies that intensified prevention produced minimal additional benefit. Offering all children only basic prevention could have obtained virtually the same preventive effect with substantially less effort and lower cost.

Five year follow up of a phase II study of cytotoxic immunotherapy combined with radiation in newly diagnosed prostate cancer

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 4635-4635 ◽  
Author(s):  
L. K. Aguilar ◽  
B. Teh ◽  
W. Mai ◽  
J. Caillouet ◽  
G. Ayala ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
High Risk ◽  
Controlled Trial ◽  
Pathologic Complete Response ◽  
Low Risk ◽  
Control Group ◽  
Newly Diagnosed ◽  
Kinase Gene ◽  
Cell Immunity

4635 Background: In the U.S. there are about 70,000 annual prostate cancer recurrences. The purpose of this study is to evaluate a product to decrease incidence of recurrence. This study is based on objective clinical responses in Phase I studies with AdV-tk (ProstAtak™, Advantagene, Inc) as monotherapy in recurrent disease and preclinical data demonstrating synergy between AdV-tk and radiation. AdV-tk is an adenoviral vector expressing the herpes thymidine kinase gene delivered to the prostate via TRUS-guided injection followed by 14 days of oral prodrug. The mechanisms of function involve direct tumor cytotoxicity, local elicitation of danger signals, recruitment and activation of antigen presenting cells and stimulation of systemic anti-tumor T-cell immunity. Method: AdV-tk was evaluated in combination with radiation in 66 newly diagnosed patients: 33 low risk (Arm A, PSA <10, Gleason <7, and T1c-T2a) and 33 intermediate-high risk (Arm B, PSA ≥10, Gleason ≥7, or T2b-T3). Arm A received two treatments with AdV-tk, immediately before and 14 days into radiation. Arm B received an additional treatment at initiation of androgen deprivation therapy. Results: Two surrogate and one definitive end-point were evaluated. Frequency of patients in Arm A with PSA nadir ≤0.2 ng/ml was 71% vs 56% in a control group of concurrent patients without AdV-tk. The two-year pathologic complete response (pCR) rate by sextant biopsy was 90% in Arm A and 94% in Arm B, compared to an expected range of 70–73%. Freedom from failure (FFF) after 60 month median follow up is 100% for Arm A and 90% for Arm B (95% for intermediate, 75% for high risk) vs best reported results of 79–90% for low risk and 48–79% for intermediate-high risk patients. The three failures in Arm B occurred within months after treatment leading to a Kaplan-Meier curve that plateaus at 90% beyond year 3. This is notably different than previous reports in which the curves continue to drop beyond year 5. Conclusion: These results suggest that AdV-tk combined with radiation therapy may significantly reduce the recurrence rate in patients with prostate cancer, particularly in patients with intermediate-high risk disease. A randomized controlled trial is warranted. [Table: see text]

scholarly journals A Randomized Placebo-Controlled Phase 2 Study of Metformin for the Prevention of Progression of Monoclonal Gammopathy of Undetermined Significance and Low Risk Smoldering Multiple Myeloma

Blood ◽  
2021 ◽  
Vol 138 (Supplement 1) ◽  
pp. 1659-1659
Author(s):  
Catherine R. Marinac ◽  
Robert A. Redd ◽  
Julia Prescott ◽  
Alexandra Savell ◽  
Courtney Igne ◽  
...  
Keyword(s):  
High Risk ◽  
Board Of Directors ◽  
Monoclonal Gammopathy ◽  
Research Funding ◽  
Controlled Trial ◽  
Low Risk ◽  
M Protein ◽  
Advisory Committees ◽  
Randomized Controlled ◽  
Bone Marrow Plasma

Abstract Background: Multiple Myeloma (MM) is thought to evolve from the precursor conditions monoclonal gammopathy of undetermined significance (MGUS) and smoldering MM (SMM), which are common premalignant disorders that progress to overt MM in a subset of individuals for reasons that are poorly understood. Despite increasing interest in preventing disease progression in this patient population, the standard of care still consists of close surveillance until progression to MM; however, once MM develops it cannot be cured. Therefore, the identification of prevention and interception strategies for patients with MGUS and SMM is of considerable importance. A promising pharmacologic intervention to reduce the risk of progression of MGUS/SMM to MM is metformin, a drug commonly used to treat type 2 diabetes but that is also considered safe for use in non-diabetic populations. In vivo and in vitro studies have revealed that metformin has direct antitumor effects across a variety of cancers including MM, and recent epidemiological data suggests it may reduce the risk of MM in diabetic patients with MGUS. Here, we describe the first randomized controlled trial testing the efficacy of metformin in reducing clinical signs of disease progression in patients with MGUS and SMM (NCT04850846). Study Design and Methods: This is a phase II single center, randomized controlled trial of metformin vs. placebo in patients with high-risk MGUS and low-risk SMM. The primary objective of the study is to determine whether metformin can reduce or stabilize serum monoclonal (M-)protein concentrations from baseline to 6-months. Exploratory objectives include mass spectrometry quantification of M-protein, examination of molecular evolution of tumor cells in response to metformin, as well as changes in other clinical laboratory parameters in response to metformin. To be eligible, patients must have high-risk MGUS or low-risk SMM. High-risk MGUS is defined as bone marrow plasma cell concentration &lt;10% with one or more of the following higher-risk features: serum M-protein level ≥1.5 g/dL to &lt;3 g/dL or abnormal free light-chain (FLC) ratio (&lt;0.26 or&gt;1.65); a forthcoming amendment will include non-IgG subtype as an additional high-risk feature. Low-risk SMM is defined as bone marrow plasma cells ≥10%with the absence of any features of high-risk SMM. Metformin and its corresponding placebo are the pharmacological treatments. The metformin dose is 1500 milligrams/day, provided in 500 milligram pills. To minimize gastrointestinal symptoms, metformin is started at a low dose of 500 milligram (1 pill) per day and participants gradually increase the dosage over the course of the first month of treatment until the full 1500 milligram (3 pill) per day regimen is achieved. The study treatment period is 6 months, with primary outcomes assessed at the end of the 6-month treatment period. Conclusions and Future Directions: While the cornerstone of clinical management in MGUS and SMM is to delay therapy until progression to symptomatic MM, patients and oncologists continually seek new ways to prevent end organ damage and incurable malignancy. This trial is positioned to provide preliminary but robust mechanistic data to support the development of novel prevention strategies for MGUS and SMM patients. Disclosures Marinac: GRAIL Inc: Research Funding; JBF Legal: Consultancy. Sperling: Adaptive: Consultancy. Parnes: Sigilon: Membership on an entity's Board of Directors or advisory committees; Genentech: Membership on an entity's Board of Directors or advisory committees; UniQure: Membership on an entity's Board of Directors or advisory committees; Sunovion: Consultancy; I-mAb: Consultancy; Aspa: Consultancy; Genentech/Hoffman LaRoche: Research Funding; Shire/Takeda: Membership on an entity's Board of Directors or advisory committees, Research Funding. Richardson: Protocol Intelligence: Consultancy; Regeneron: Consultancy; Sanofi: Consultancy; Secura Bio: Consultancy; AbbVie: Consultancy; Janssen: Consultancy; GlaxoSmithKline: Consultancy; AstraZeneca: Consultancy; Karyopharm: Consultancy, Research Funding; Takeda: Consultancy, Research Funding; Celgene/BMS: Consultancy, Research Funding; Oncopeptides: Consultancy, Research Funding; Jazz Pharmaceuticals: Consultancy, Research Funding. Ghobrial: AbbVie, Adaptive, Aptitude Health, BMS, Cellectar, Curio Science, Genetch, Janssen, Janssen Central American and Caribbean, Karyopharm, Medscape, Oncopeptides, Sanofi, Takeda, The Binding Site, GNS, GSK: Consultancy. Nadeem: Karyopharm: Membership on an entity's Board of Directors or advisory committees; Adaptive Biotechnologies: Membership on an entity's Board of Directors or advisory committees; Takeda: Membership on an entity's Board of Directors or advisory committees; BMS: Membership on an entity's Board of Directors or advisory committees; GSK: Membership on an entity's Board of Directors or advisory committees. OffLabel Disclosure: metformin, which is an anti-diabetic medication

scholarly journals Protocol for a multinational risk-stratified randomised controlled trial in paediatric Crohn’s disease: methotrexate versus azathioprine or adalimumab for maintaining remission in patients at low or high risk for aggressive disease course

BMJ Open ◽  
2020 ◽  
Vol 10 (7) ◽  
pp. e034892
Author(s):  
Rachel E Harris ◽  
Marina Aloi ◽  
Lissy de Ridder ◽  
Nicholas M Croft ◽  
Sibylle Koletzko ◽  
...  
Keyword(s):  
High Risk ◽  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Risk Groups ◽  
Low Risk ◽  
High Risk Patients ◽  
Link Type ◽  
Risk Patients ◽  
Randomised Controlled ◽  
Paediatric Crohn’S Disease

IntroductionImmunomodulators such as thiopurines (azathioprine (AZA)/6-mercaptopurine (6MP)), methotrexate (MTX) and biologics such as adalimumab (ADA) are well established for maintenance of remission within paediatric Crohn’s disease (CD). It remains unclear, however, which maintenance medication should be used first line in specific patient groups.AimsTo compare the efficacy of maintenance therapies in newly diagnosed CD based on stratification into high and low-risk groups for severe CD evolution; MTX versus AZA/6MP in low-risk and MTX versus ADA in high-risk patients. Primary end point: sustained remission at 12 months (weighted paediatric CD activity index ≤12.5 and C reactive protein ≤1.5 fold upper limit) without relapse or ongoing requirement for exclusive enteral nutrition (EEN)/steroids 12 weeks after treatment initiation.Methods and analysisREDUCE-RISK in CD is an international multicentre open-label prospective randomised controlled trial funded by EU within the Horizon2020 framework (grant number 668023). Eligible patients (aged 6–17 years, new-onset disease receiving steroids or EEN for induction of remission for luminal ± perianal CD are stratified into low and high-risk groups based on phenotype and response to induction therapy. Participants are randomised to one of two treatment arms within their risk group: low-risk patients to weekly subcutaneous MTX or daily oral AZA/6MP, and high-risk patients to weekly subcutaneous MTX or fortnightly ADA. Patients are followed up for 12 months at prespecified intervals. Electronic case report forms are completed prospectively. The study aims to recruit 312 participants (176 low risk; 136 high risk).Ethics and disseminationClinicalTrials.gov Identifier: (NCT02852694), authorisation and approval from local ethics committees have been obtained prior to recruitment. Individual informed consent will be obtained prior to participation in the study. Results will be published in a peer-reviewed journal with open access.Trial registration numberNCT02852694; Pre-results.

P1006IMPACT OF GLUCOSE-LOWERING AND ANTIHYPERTENSIVE MEDICATIONS ON DEVELOPMENT OF MICROALBUMINURIA IN SUBJECTS WITH TYPE 2 DIATETES AND NORMOALBUMINURIA IN THE PRIORITY STUDY

2020 ◽  
Vol 35 (Supplement_3) ◽  
Author(s):  
Nete Tofte ◽  
Morten Lindhardt ◽  
Gemma Currie ◽  
Marie Frimodt-Moeller ◽  
Heiko Von der Leyen ◽  
...  
Keyword(s):  
High Risk ◽  
Cox Model ◽  
Controlled Trial ◽  
Low Risk ◽  
Channel Blockers ◽  
Antihypertensive Medications ◽  
Converting Enzyme Inhibitors ◽  
Glucose Lowering ◽  
Increased Risk ◽  
Dipeptidyl Peptidase 4 Inhibitors

Abstract Background and Aims In the PRIORITY study, it was recently demonstrated that the urinary peptidome-based classifier CKD273 was associated with increased risk for progression to microalbuminuria. In this sub-study, we aim to evaluate whether glucose-lowering and antihypertensive medications, many of which have been demonstrated to have albuminuria-lowering effects, may interfere with the predictive value of CKD273. Method A post hoc analysis of a prospective observational study with embedded randomised placebo-controlled trial. Setting 1775 subjects from 15 European sites with a mean follow-up time of 2.6 years (minimum of 7 days and a maximum of 4.3 years). Patients Subjects with T2D, normoalbuminuria and estimated glomerular filtration rate (eGFR) ≥ 45 ml/min/1.73m2. Participants were stratified into high- or low-risk groups based on their CKD273 score in a urine sample at screening (high-risk defined as score &gt; 0.154). Main outcome measures Baseline medication or initiation during the study was assessed for the following medications: glitazones, glucagon-like peptide-1 receptor agonists (GLP1-RA), sodium-glucose cotransporter-2 inhibitors (SGLT2i), dipeptidyl peptidase-4 inhibitors (DPP4i), angiotensin-converting-enzyme inhibitors (ACEi), angiotensin-II-receptor blockers (ARB), calcium channel blockers (CCB) and beta blockers (BB). The main outcome was development of confirmed microalbuminuria (urinary albumin to creatinine ratio (UACR) &gt;30 mg/g and with ≥30% increase from baseline) in 2 of 3 consecutive samples. Results The hazard ratio (HR (95% CI)) for development of microalbuminuria (high vs. low-risk) was 3.9 (2.9-5.3) in a crude Cox-model; and 2.4 (1.8-3.4; p&lt;0.0001) when adjusted for age, sex, HbA1c, systolic blood pressure, retinopathy, eGFR and UACR. Adding baseline medications to the model did not significantly alter the results. When evaluating medications initiated during the study, more high- than low-risk subjects were started on glitazones, GLP1-RA, SGLT2i, CCB and BB (p&lt;0.03), however, only initiation of DPP4i was associated with the outcome. Adjustment for DPP4i initiated during the study did not significantly change the HR for development of confirmed microalbuminuria (HR 2.5 (1.8 to 3.4); p&lt;0.0001) in a model including eGFR and UACR. The HR for development of persistent microalbuminuria (spironolactone vs. placebo) was 0.81 (0.49-1.34; p=0.41), however, adjusting for DPP4i did not significantly alter this result. Conclusion Although several glucose-lowering and antihypertensive medications were more frequently prescribed in high-risk subjects, the CKD273 classifier prospectively predicted confirmed microalbuminuria, independent of baseline co-medications and medication initiated during the study. Moreover, initiated medications during the study could not explain the inability of spironolactone to delay progression to microalbuminuria.

Five-year treat-to-target outcomes after methotrexate induction therapy with or without other csDMARDs and temporary glucocorticoids for rheumatoid arthritis in the CareRA trial

2021 ◽  
pp. annrheumdis-2020-219825
Author(s):  
Veerle Stouten ◽  
René Westhovens ◽  
Sofia Pazmino ◽  
Diederik De Cock ◽  
Kristien Van der Elst ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
High Risk ◽  
Disease Activity ◽  
Controlled Trial ◽  
Health Assessment ◽  
Low Risk ◽  
Treat To Target ◽  
Longitudinal Models ◽  
High Risk Patients ◽  
Risk Patients

ObjectivesTo compare outcomes of different treatment schedules from the care in early rheumatoid arthritis (CareRA) trial over 5 years.MethodsPatients with RA completing the 2-year CareRA randomised controlled trial were eligible for the 3-year observational CareRA-plus study. 5-year outcomes after randomisation to initial methotrexate (MTX) monotherapy with glucocorticoid bridging (COBRA-Slim) were compared with MTX step-up without glucocorticoids or conventional synthetic disease-modifying antirheumatic drug (DMARD) combinations with glucocorticoid bridging, per prognostic patient group. Disease activity (Disease Activity Score based on 28 joints calculated with C reactive protein (DAS28-CRP)) and functionality (Health Assessment Questionnaire (HAQ)) were compared between treatment arms using longitudinal models; safety and drug use were detailed.ResultsOf 322 eligible patients, 252 (78%) entered CareRA-plus, of which 203 (81%) completed the study. Treatments for high-risk patients resulted in comparable DAS28-CRP (p=0.539) and HAQ scores over 5 years (p=0.374). Low-risk patients starting COBRA-Slim had lower DAS28-CRP (p<0.001) and HAQ scores (p=0.041) than those starting only on MTX. At study completion, 114/203 (56%) patients never had their original DMARD therapy intensified, with comparable rates between all treatments. Safety was comparable between treatments in high-risk patients. In low-risk patients, there were 18 adverse events in 10 COBRA-Slim and 36 in 17 patients treated with initial MTX monotherapy (p=0.048). Over 5 years, 22% of patients initiated biologics, 25% took glucocorticoids for >3 months and 17% for >6 months outside the bridging period.ConclusionsAll intensive treatments with glucocorticoids bridging demonstrated excellent 5 year outcomes. Initiating COBRA-Slim was comparably effective as more complex treatments for high-risk patients with early RA and more effective than initial MTX monotherapy for low-risk patients with limited need for biologics and chronic glucocorticoid use.

A Low-Risk Approach to High-Risk Students

1991 ◽  
Vol 75 (538) ◽  
pp. 50-58
Author(s):  
Shayle Uroff ◽  
Brad Greene
Keyword(s):  
High Risk ◽  
Low Risk ◽  
Risk Approach ◽  
High Risk Students

scholarly journals Cost of an unforced error in tennis: a statistical approach

2021 ◽  
Vol 29 (84) ◽  
pp. 12-14
Author(s):  
Hemant Attray ◽  
Saksham Attray
Keyword(s):  
High Risk ◽  
Statistical Approach ◽  
Low Risk ◽  
Median Cost ◽  
Risk Approach ◽  
The Right ◽  
The Cost

The objective of this paper is to (1) introduce a scientific way of measuring the cost of an unforced error in tennis during various match situations and (2) to provide a basis for players and coaches to choose the right strategy among extremely cautious and adventurous playing styles based on a statistical approach. To do this, we analyzed a total of 2,490 different match situations. The results of this study show that the cost of an unforced error varies greatly depending on the match situation. Players are better served by playing a high percentage, low-risk game in situations when the cost of an unforced error is higher than the median cost and adapt a high-risk approach when it is lower than the median cost.

scholarly journals Management of Anticoagulation and Colonoscopy

2021 ◽  
Author(s):  
Michael O’Donnell ◽  
Seth A. Gross
Keyword(s):  
Cardiovascular Disease ◽  
High Risk ◽  
Antithrombotic Therapy ◽  
Controlled Trial ◽  
Low Risk ◽  
Antithrombotic Agents ◽  
Delayed Hemorrhage ◽  
Risk Patients ◽  
Cold Snare Polypectomy ◽  
Risk Of Hemorrhage

Abstract Purpose of review Patients undergoing colonoscopy frequently require antithrombotic therapy for underlying cardiovascular disease. Antithrombotic therapy increases the risk of bleeding during or after colonoscopy, particularly when more invasive procedures are required. However, the risk of thrombosis—with possibly devastating consequences—is increased if antithrombotic agents are held. This review will highlight existing data on the balance of procedural and patient risk factors to guide endoscopists on the management of periprocedural antithrombotic therapy. Recent findings Diagnostic colonoscopy has long been established to be low risk for hemorrhage even in patients on antithrombotic therapy, while colonoscopy with interventions—including polypectomy—is viewed as high risk requiring interruption of antithrombotic therapy when possible. Recent data, however, has challenged these practices and suggests that a more nuanced perspective may be necessary. For example, a recent randomly controlled trial found no difference in immediate or delayed hemorrhage between patients on dual antiplatelet therapy versus aspirin and placebo after polypectomy. Further, increasing data are emerging to suggest that small polypectomy (< 1 cm) is safe without interruption of anticoagulation with the use of cold snare polypectomy. Summary In patients undergoing colonoscopy, the risk of hemorrhage must be weighed against the risk of thrombosis in patients with cardiovascular disease on antithrombotic agents. In general, low-risk procedures do not require interruption of antithrombotic agents, while high-risk procedures in low-risk patients require holding antithrombotic therapy. High-risk procedures in high-risk patients require individualized decision-making with increasing data helping to support which procedures can safely be performed.

scholarly journals Assessment of an intervention to optimise antenatal management of women admitted with preterm labour and intact membranes using amniocentesis-based predictive risk models: study protocol for a randomised controlled trial (OPTIM-PTL Study)

BMJ Open ◽  
2021 ◽  
Vol 11 (9) ◽  
pp. e054711
Author(s):  
Teresa Cobo ◽  
Victoria Aldecoa ◽  
Jose Luis Bartha ◽  
Fernando Bugatto ◽  
María Paz Carrillo-Badillo ◽  
...  
Keyword(s):  
High Risk ◽  
Hospital Stay ◽  
Preterm Labour ◽  
Controlled Trial ◽  
Dropout Rate ◽  
Low Risk ◽  
Control Group ◽  
Type I ◽  
Microbial Invasion ◽  
Predictor Models

IntroductionThe majority of women admitted with threatened preterm labour (PTL) do not delivery prematurely. While those with microbial invasion of the amniotic cavity (MIAC) represent the highest risk group, this is a condition that is not routinely ruled out since it requires amniocentesis. Identification of low-risk or high-risk cases might allow individualisation of care, that is, reducing overtreatment with corticosteroids and shorten hospital stay in low-risk women, while allowing early antibiotic therapy in those with MIAC. Benefits versus risks of amniocentesis-based predictor models of spontaneous delivery within 7 days and/or MIAC have not been evaluated.Methods and analysisThis will be a Spanish randomised, multicentre clinical trial in singleton pregnancies (23.0–34.6 weeks) with PTL, conducted in 13 tertiary centres. The intervention arm will consist in the use of amniocentesis-based predictor models: if low risk, hospital discharge within 24 hours of results with no further medication will be recommended. If high risk, antibiotics will be added to standard management. The control group will be managed according to standard institutional protocols, without performing amniocentesis for this indication. The primary outcome will be total antenatal doses of corticosteroids, and secondary outcomes will be days of maternal stay and the occurrence of clinical chorioamnionitis. A cost analysis will be undertaken. To observe a reduction from 90% to 70% in corticosteroid doses, a reduction in 1 day of hospital stay (SD of 2) and a reduction from 24% to 12% of clinical chorioamnionitis, a total of 340 eligible patients randomised 1 to 1 to each study arm is required (power of 80%, with type I error α=0.05 and two-sided test, considering a dropout rate of 20%). Randomisation will be stratified by gestational age and centre.Ethics and disseminationPrior to receiving approval from the Ethics Committee (HCB/2020/1356) and the Spanish Agency of Medicines and Medical Devices (AEMPS) (identification number: 2020-005-202-26), the trial was registered in the European Union Drug Regulating Authorities Clinical Trials database (2020-005202-26). AEMPS approved the trial as a low-intervention trial. All participants will be required to provide written informed consent. Findings will be disseminated through workshops, peer-reviewed publications and national/international conferences.Protocol versionV.4 10 May 2021.Trial registration numbersNCT04831086 and Eudract number 2020-005202-26.

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