Treatment of classic mid-trimester preterm premature rupture of membranes (PPROM) with oligo/ anhydramnion between 22 – 26 weeks’ gestation by means of continuous amnioinfusion: a randomized multicentric prospective controlled TRIAL

Abstract Background: The classic mid-trimester preterm premature rupture of membranes (PPROM), is defined as rupture of fetal membranes prior to 28 weeks’ gestation (WG) with oligo/ anhydramnion, complicates approximately 0.4-0.7% of all pregnancies and is associated with very high neonatal mortality and morbidity.Antibiotics have limited success to prevent bacterial growth, chorioamnionitis and fetal inflammation. The repetitive amnioinfusion doesn’t work because of immediately fluid lost after the intervention. The continuous amnioinfusion through the transabdomianal port system or catheter in patients with classic PPROM shows promise by flush out of bacteria and inflammatory components from the amniotic cavity, replacing amniotic fluid and thus prolonging PPROM-to-delivery interval.Aim: This multicenter trial tests the effect of continuous amnioinfusion on the neonatal survival without the typical major morbidities, like severe bronchopulmonary dysplasia, intraventricular hemorrhage, cystic periventricular leukomalacia and necrotizing enterocolitis one year after the delivery.Methods/Design: randomized multicenter trial; two-arm parallel design. Control group: PPROM patients between 22/0 (20/0) -26/0 WG treated with antibiotics and corticosteroids in accordance to guidelines of German Society of Obstetrics and Gynecology (standard PPROM therapy). In the interventional group the standard PPROM therapy will be complemented by “Amnion Flush Method” with the amnioinfusion of artificial amniotic fluid (up to 100 ml/h, 2400 ml/day).Subjects: 68 patients with classic PPROM between 22/0 (20/0)-26/0 WG.TRIAL-registration: ClinicalTrials.gov ID: NCT04696003 and German Clinical Trials Register: DRKS00024503, January 2021.The trial is approved by the Ethic committee of the Martin-Luther University Halle-Wittenberg (2020-185, January 25, 2021).

Download Full-text

Hysteroscopic management of a uterine caesarean scar defect (niche) in women with postmenstrual spotting: a randomised controlled trial

QJM ◽

10.1093/qjmed/hcab115.005 ◽

2021 ◽

Vol 114 (Supplement_1) ◽

Author(s):

Hatem Hussein El-Gamal ◽

Walid El-Basuony Mohammad ◽

Ahmed Samir Mohamed Zeerban

Keyword(s):

Quality Of Life ◽

Caesarean Section ◽

Controlled Trial ◽

Intervention Group ◽

Expectant Management ◽

Control Group ◽

Randomised Controlled ◽

Caesarean Scar Defect ◽

Interventional Group

Abstract Background Long-term complaints after caesarean section, such as postmenstrual spotting, dysmenorrhea, dyspareunia, or chronic pelvic pain, are frequently described in relation to the presence of a niche. A post-caesarean niche is defined as an indentation in the myometrium at the site of the uterine scar. Two independent prospective cohort studies reported that the presence of a niche after caesarean section increases the risk of postmenstrual spotting for more than 2 days from 15 to 30%. Postmenstrual spotting may be caused by a mechanical outflow problem, with the retention of menstrual blood in a niche, or by the accumulation of blood because of impaired uterine contractions at the site of the niche. Additionally, newly formed fragile vessels in the niche may play a role in the formation of blood or fluid in the niche and uterine cavity. Objective The aim of this study was to compare the effectiveness of a hysteroscopic niche resection versus no treatment in women with postmenstrual spotting and a uterine caesarean scar defect. Methods This trial is a randomised controlled trial that provides evidence for the (cost) effectiveness of hysteroscopic resection of a niche versus expectant management in women with niche related postmenstrual spotting. It was carried out on 28 cases divided into two equal group. The study was conducted at Ain Shams University on the women reporting postmenstrual spotting after a caesarean section. The primary outcome was the number of days of postmenstrual spotting 6 months after randomization. Secondary outcomes were spotting at the end of menstruation, intermenstrual spotting, dysuria, sonographic niche measurements, quality of life, women’s satisfaction, sexual function, and additional therapy. Outcomes were measured at 3 months and, also at 6 months after randomization. Results The results of this study show a significant improvement in interventional group after 3 months more than the control group in bleeding micturition characteristics which includes total days of spotting, spotting end of menstruation, intermenstral spotting, discomfort from spotting, dysmenorrhea and daily pain during micturition, after 6 months the two group improved but the interventional group was significantly higher than control group. Regarding the radiological assessment it was found that there was a significant improvement in intervention group more than the control group after 3 months, also the control group improved after 6 months also, but the intervention groups was significantly higher than the control group. The quality of life show a significant increasing in intervention group more than the control group after 3 months of intervention, at the end of follow up the intervention group was significantly higher in quality of life more than the control group. Conclusion A hysteroscopic niche resection reduces postmenstrual spotting, and the discomfort from spotting, compared with expectant management after 3 months of follow-up in women with a niche with a residual myometrium of at least 3 mm.

Download Full-text

E-healthcare for diabetes mellitus type 2 patients – a randomised controlled trial in Slovenia

Slovenian Journal of Public Health ◽

10.1515/sjph-2017-0020 ◽

2017 ◽

Vol 56 (3) ◽

pp. 150-157 ◽

Cited By ~ 2

Author(s):

Rade Iljaž ◽

Andrej Brodnik ◽

Tatjana Zrimec ◽

Iztok Cukjati

Keyword(s):

Diabetes Mellitus ◽

Blood Pressure ◽

Nurse Practitioners ◽

Controlled Trial ◽

Control Group ◽

Web Based ◽

Patients With Diabetes ◽

Randomised Controlled ◽

Interventional Group

Abstract Background Telemonitoring and web-based interventions are increasingly used in primary-care practices in many countries for more effective management of patients with diabetes mellitus (DM). A new approach in treating patients with diabetes mellitus in family practices, based on ICT use and nurse practitioners, has been introduced and evaluated in this study. Method Fifteen Slovene family practices enrolled 120 DM patients treated only with a diet regime and/or tablets into the study. 58 of them were included into the interventional group, and the other 62 DM patients into the control group, within one-year-long interventional, randomised controlled trial. Patients in the control group had conventional care for DM according to Slovenian professional guidelines, while the patients in the interventional group were using also the eDiabetes application. Patients were randomised through a balanced randomisation process. Results Significant reductions of glycated haemoglobin (HbA1c) values were found after 6 and 12 months among patients using this eDiabetes application (p<0.05). Among these patients, a significant correlation was also found between self-monitored blood pressure and the final HbA1c values. Diabetic patients’ involvement in web-based intervention had only transient impact on their functional health status. Conclusion This eDiabetes application was confirmed to be an innovative approach for better self-management of DM type 2 patients not using insulin. Both a significant reduction of HbA1c values and a significant correlation between the average self-measured blood pressure and the final HbA1c values in the interventional group were found. Nurse practitioners – as diabetes care coordinators – could contribute to better adherence in diabetes e-care.

Download Full-text

A Controlled Trial of Home-Based Acute Psychiatric Services

The British Journal of Psychiatry ◽

10.1192/bjp.163.1.49 ◽

1993 ◽

Vol 163 (1) ◽

pp. 49-54 ◽

Cited By ~ 90

Author(s):

Tom Burns ◽

Alan Beadsmoore ◽

Ashok V. Bhat ◽

Andrew Oliver ◽

Carola Mathers

Keyword(s):

Controlled Trial ◽

Controlled Study ◽

Control Group ◽

Community Based ◽

Home Based ◽

Randomised Controlled Study ◽

One Year ◽

Randomised Controlled ◽

Clinical Measures ◽

Experimental Group

While research has shown community-based psychiatric care to be as good as, or better than, hospital-based care, generalisation to clinical practice has been difficult. This prospective, randomised controlled study examined a community-based approach feasible within NHS conditions. Ninety-four patients were randomly allocated to experimental and 78 to control treatments and followed for one year. The groups were well matched apart from an excess of psychotic control patients. No differences in clinical or social functioning outcome were found. Both groups improved substantially on clinical measures in the first six weeks, with some slow consolidation thereafter. There were three suicides in the control group and one in the experimental group. Access to care was better in the experimental group (93% attended assessment) than in the control group (75% attended assessment).

Download Full-text

Screening for Atrial Fibrillation in Older Adults at Primary Care Visits: the VITAL-AF Randomized Controlled Trial

10.1101/2021.08.13.21261969 ◽

2021 ◽

Author(s):

Steven Lubitz ◽

Steven J. Atlas ◽

Jeffrey M. Ashburner ◽

Ana Lipsanopoulos ◽

Leila Borowsky ◽

...

Keyword(s):

Atrial Fibrillation ◽

Primary Care ◽

Usual Care ◽

Controlled Trial ◽

Oral Anticoagulants ◽

Care Practice ◽

Control Group ◽

Newly Diagnosed ◽

One Year ◽

And Control

Background: Undiagnosed atrial fibrillation (AF) may cause preventable strokes. Guidelines differ regarding AF screening recommendations. We tested whether point-of-care screening with a handheld single lead electrocardiogram (ECG) at primary care practice visits increases diagnoses of AF. Methods: We randomized 16 primary care clinics 1:1 to AF screening using a handheld single-lead ECG (AliveCor KardiaMobile) during vital sign assessments, or usual care. Patients included were aged ≥ 65 years. Screening results were provided to primary care clinicians at the encounter. All confirmatory diagnostic testing and treatment decisions were made by the primary care clinician. New AF diagnoses over one-year follow-up were ascertained electronically and manually adjudicated. Proportions and incidence rates were calculated. Effect heterogeneity was assessed. Results: Of 30,715 patients without prevalent AF (n=15,393 screening [91% screened], n=15,322 control), 1.72% of individuals in the screening group had new AF diagnosed at one year versus 1.59% in the control group (risk difference [RD] 0.13%, 95% confidence interval [CI] -0.16,0.42, P=0.38). New AF diagnoses in the screening and control groups differed by age with the greatest effect observed for those aged ≥ 85 years (5.56% versus 3.76%, respectively, RD 1.80%, 95% CI 0.18,3.30). The difference in newly diagnosed AF between the screening period and the prior year was marginally greater in the screening versus control group (0.32% versus -0.12%, RD 0.43%, 95% CI -0.01,0.84). The proportion of individuals with newly diagnosed AF who were initiated on oral anticoagulants was similar in the screening (n=194, 73.5%) and control (n=172, 70.8%) arms (RD 2.7%, 95% CI -5.5,10.4). Conclusions: Screening for AF using a single-lead ECG at primary care visits was not associated with a significant increase in new AF diagnoses among individuals aged 65 years or older compared to usual care. However, screening may be associated with an increased likelihood of diagnosing AF among individuals aged 85 years or older and warrants further evaluation.

Download Full-text

150 Falls in Malaysia: Magnitude, Risk, Disparities, and Solutions

Age and Ageing ◽

10.1093/ageing/afz164.150 ◽

2019 ◽

Vol 48 (Supplement_4) ◽

pp. iv34-iv39

Author(s):

Maw Pin Tan ◽

Sumaiyah Mat ◽

Deepa Alex ◽

Shahrul Bahyah Kamaruzzaman

Keyword(s):

Ethnic Differences ◽

Cultural Practices ◽

Longitudinal Research ◽

Controlled Trial ◽

Intervention Group ◽

Psychological Status ◽

Control Group ◽

Cross Sectional ◽

One Year ◽

Risk Factors For Falls

Abstract The Malaysian Elders Longitudinal Research (MELoR) study found 1 in 4 residents aged 65 years and over living in the Klang Valley of Malaysia fall at least once a year in their survey conducted between 2013 and 2015. Recent figures obtained from the First Older Persons’ National Health and Morbidity Survey conducted in 2018 revealed that 15% of Malaysians aged 60 years and over fall at least once a year. In a 10-year follow-up study involving 200 individuals who presented to the emergency department over a six-month period in 2002, 22% were no longer alive at one year, and 80% had died at 10 years. Older age, indoor falls, subsequent hospital admission and functional impairment predicted death at one year. Cross-sectional data from MELoR revealed ethnic differences in fall prevalence, with the ethnic Indians more likely to report falls in the past 12 months compared to the ethnic Malays. Independent risk factors for falls identified from MELoR were urinary incontinence, reduced grip strength, hearing impairment, comorbidities and reducing walking speed. The ethnic differences in falls in our population remain unexplained. Lifestyle and cultural practices may well be the underlying rationale, but genetic influences cannot currently be ruled out. The results of a randomized controlled trial on multifactorial interventions, the Malaysian Falls Assessment and Intervention Trial (MyFAIT), was published last year. Mo differences in falls outcomes with an individualized multifactorial intervention were observed, despite improvements in physical performance and psychological status in the intervention group compared to the control group. The research group has now secured two-year funding to evaluate post-fall behavior in our setting in the Life After Falls (LiAF) study. In addition, dissemination and upskilling efforts are underway through training workshops, formation of the Malaysian Falls Network (MyFalls) and collaborations with the private sector to increase awareness on falls and increase fall prevention efforts throughout the country.

Download Full-text

Effect of HSV-2 Suppressive Therapy on Genital Tract HIV-1 RNA Shedding among Women on HAART: A Pilot Randomized Controlled Trial

Infectious Diseases in Obstetrics and Gynecology ◽

10.1155/2012/868526 ◽

2012 ◽

Vol 2012 ◽

pp. 1-7

Author(s):

A. E. Nijhawan ◽

A. K. DeLong ◽

S. Chapman ◽

A. Rana ◽

J. Kurpewski ◽

...

Keyword(s):

Highly Active Antiretroviral Therapy ◽

Genital Tract ◽

Controlled Trial ◽

Sexual Transmission ◽

Suppressive Therapy ◽

Control Group ◽

Highly Active ◽

One Year ◽

Hiv 1

Background. The role of suppressive HSV therapy in women coinfected with HSV-2 and HIV-1 taking highly active antiretroviral therapy (HAART) is unclear.Methods. 60 women with HIV-1/HSV-2 coinfection on HAART with plasma HIV-1 viral load (PVL) ≤75 copies/mL were randomized to receive acyclovir (N=30) or no acyclovir (N=30). PVL, genital tract (GT) HIV-1, and GT HSV were measured every 4 weeks for one year.Results. Detection of GT HIV-1 was not significantly different in the two arms (OR 1.23,P=0.67), although this pilot study was underpowered to detect this difference. When PVL was undetectable, the odds of detecting GT HIV were 0.4 times smaller in the acyclovir arm than in the control arm, though this was not statistically significant (P=0.07). The odds of detecting GT HSV DNA in women receiving acyclovir were significantly lower than in women in the control group, OR 0.38,P<0.05.Conclusions. Chronic suppressive therapy with acyclovir in HIV-1/HSV-2-positive women on HAART significantly reduces asymptomatic GT HSV shedding, though not GT HIV shedding or PVL. PVL was strongly associated with GT HIV shedding, reinforcing the importance of HAART in decreasing HIV sexual transmission.

Download Full-text

Impact of the TEAM Wheels eHealth manual wheelchair training program: Study protocol for a randomized controlled trial

PLoS ONE ◽

10.1371/journal.pone.0258509 ◽

2021 ◽

Vol 16 (10) ◽

pp. e0258509

Author(s):

Ed Giesbrecht ◽

Julie Faieta ◽

Krista Best ◽

François Routhier ◽

William C. Miller ◽

...

Keyword(s):

Training Program ◽

Controlled Trial ◽

Community Setting ◽

Skills Training ◽

Control Group ◽

Wait List ◽

Manual Wheelchair ◽

And Performance ◽

One Year ◽

Home Training

Background Variable, and typically inadequate, delivery of skills training following manual wheelchair (MWC) provision has a detrimental impact on user mobility and participation. Traditional in-person delivery of training by rehabilitation therapists has diminished due to cost, travel time, and most recently social distancing restrictions due to COVID-19. Effective alternative training approaches include eHealth home training applications and interactive peer-led training using experienced and proficient MWC users. An innovative TEAM Wheels program integrates app-based self-training and teleconference peer-led training using a computer tablet platform. Objective This protocol outlines implementation and evaluation of the TEAM Wheels training program in a randomized control trial using a wait-list control group. Setting The study will be implemented in a community setting in three Canadian cities. Participants Individuals ≥ 18 years of age within one year of transitioning to use of a MWC. Intervention Using a computer tablet, participants engage in three peer-led teleconference training sessions and 75–150 minutes of weekly practice using a video-based training application over 4 weeks. Peer trainers individualize the participants’ training plans and monitor their tablet-based training activity online. Control group participants also receive the intervention following a 1-month wait-list period and data collection. Measurements Outcomes assessing participation; skill capacity and performance; self-efficacy; mobility; and quality of life will be measured at baseline and post-treatment, and at 6-month follow-up for the treatment group. Impact statement We anticipate that TEAM Wheels will be successfully carried out at all sites and participants will demonstrate statistically significant improvement in the outcome measures compared with the control group.

Download Full-text

Effectiveness of a Snoezelen Room on Fear, Anxiety, and Satisfaction of Nulliparous Women: A Randomized Controlled Trial

Iranian Journal of Psychiatry and Behavioral Sciences ◽

10.5812/ijpbs.89168 ◽

2020 ◽

Vol 14 (2) ◽

Author(s):

Mariyam Momeni ◽

Mansoureh Jamshidimanesh ◽

Hadi Ranjbar

Keyword(s):

Repeated Measures ◽

Rating Scale ◽

Controlled Trial ◽

Intervention Group ◽

Active Phase ◽

Control Group ◽

Chi Square ◽

Nulliparous Women ◽

Significant Difference ◽

Interventional Group

Background: Pregnancy and childbirth are natural phenomena in a women’s life, associated with stress and anxiety, leading to adverse effects in the mother and fetus. Using complementary medicine, such as aromatherapy, music, light radiation, and aquariums in an environment that engage a person’s multiple senses can make mothers relax through mental deviations. Objectives: The aim of this study was to evaluate the effects of a Snoezelen room on fear, anxiety, and satisfaction of childbirth’s nulliparous women. Methods: This randomized clinical trial was carried out on 130 eligible women in a selected hospital affiliated to the Iran University of Medical Sciences in Tehran. One hundred thirty women were randomly assigned to the intervention (n = 65) and control (n = 65) groups using six modes blocks using the convenient sampling method. The delivery room was designed to distract women’s minds in the intervention group. Data were collected using a demographic characteristics form, Harman’s Childbirth Attitude questionnaire (CAQ), Visual Analogue scale (VAS) to measure childbirth anxiety, and the Mackey Childbirth Satisfaction Rating scale. Data were analyzed by SPSS version 16 using independent t-test, repeated measures analysis of variance, and Bonferroni and chi-square tests. Results: The results showed a significant reduction in fear in the active phase and postpartum in the intervention group compared with the control group (P < 0.001 and P < 0.001, respectively). Anxiety showed a significant difference and was lower at dilatation of 6 to 7 and 7 to 8 cm, and after childbirth in the interventional group. The satisfaction of childbirth significantly increased in the interventional group (P < 0.001). Conclusions: These results confirmed the importance of a Snoezelen room in the childbirth of nulliparous women, which can promote vaginal childbirth.

Download Full-text

Reinforcing Adherence to Lipid-lowering Therapy after an Acute Coronary Syndrome: A Pragmatic Randomized Controlled Trial

10.21203/rs.3.rs-118012/v2 ◽

2020 ◽

Author(s):

Stefanos Zafeiropoulos ◽

Ioannis Farmakis ◽

Anastasios Kartas ◽

Alexandra Arvanitaki ◽

Konstantinos Arvanitakis ◽

...

Keyword(s):

Goal Attainment ◽

Controlled Trial ◽

Intervention Group ◽

Lipid Lowering ◽

Control Group ◽

Lipid Lowering Therapy ◽

Good Adherence ◽

Coronary Syndrome ◽

Randomized Controlled ◽

One Year

Abstract Aims: Achieving the low-density lipoprotein cholesterol (LDL-C) goal following an acute coronary syndrome (ACS) is a milestone often missed due to suboptimal adherence to secondary prevention treatments. Whether improved adherence could result in reduced LDL-C levels is unclear. We aimed to evaluate an educational-motivational intervention to increase long-term lipid-lowering therapy (LLT) adherence and LDL-C goal attainment rate among post-ACS patients.Methods: IDEAL-LDL was a parallel, two-arm, single-center, pragmatic, investigator-initiated randomized controlled trial. Hospitalized patients for ACS were randomized to a physician-led integrated intervention consisting of an educational session at baseline, followed by regular motivational interviewing phone sessions or usual care. Co-primary outcomes were the LLT adherence (measured by Proportion of Days Covered (PDC); good adherence defined as PDC>80%), and LDL-C goal (<70 mg/dl or 50% reduction from baseline) achievement rate at one year.Results: In total, 360 patients (mean age 62 years, 81% male) were randomized. Overall, good adherence was positively associated with LDL-C goal achievement rate at one year. Median PDC was higher in the intervention group than the control group [0.92 (IQR, 0.82–1.00) vs. 0.86 (0.62–0.98); p=0.03] while the intervention group had increased odds of good adherence (adjusted odds ratio: 1.76 (95% confidence interval 1.02 to 2.62; p=0.04). However, neither the rate of LDL-C goal achievement (49.6% in the intervention vs. 44.9% in the control group; p=0.49) nor clinical outcomes differed significantly between the two groups.Conclusion: Α multifaceted intervention improved LLT adherence in post-ACS patients without a significant difference in LDL-C goal attainment. (IDEAL-LDL, ClinicalTrials.gov: NCT02927808)

Download Full-text

A Randomized Trial on Breast Self-Examination in Faenza (Northern-Italy)

Tumori Journal ◽

10.1177/030089169608200407 ◽

1996 ◽

Vol 82 (4) ◽

pp. 329-334 ◽

Cited By ~ 4

Author(s):

Salvatore Ferro ◽

Annalisa Caroli ◽

Oriana Nanni ◽

Annibale Biggeri ◽

Angelo Gambi

Keyword(s):

Treatment Group ◽

Controlled Trial ◽

Northern Italy ◽

Wilcoxon Test ◽

Control Group ◽

Breast Self Examination ◽

Practical Session ◽

One Year ◽

Self Examination

Aims and background The aim of this randomized controlled trial was to compare two methods for teaching breast self-examination: theoretical and practical session versus mailed material. Methods A random sample of women aged 20-64 years was drawn from the demographic file of the city of Faenza (Northern-Italy). Of 825 sampled eligible women, 168 declined participation, 657 were randomly assigned, after completing a pretest questionnaire aimed at evaluating practice and quality of breast self-examination. Individualised instruction was administered to the treatment group invited to be taught breast self-examination in a medical practice setting. The control group received mailed information about breast self-examination. One year later, 443 women completed the posttest questionnaire. Results As far as concerns the first outcome of the trial (change in practice of breast-self examination) our study showed, after adjusting for lost-to-follow-up, no difference between the treatment and the control group. The analysis performed to evaluate the second outcome (change in quality of breast self-examination practice) showed that women of the treatment group improved the quality of breast self-examination practice more than the control group (Wilcoxon test, z=2.4, P<0.01). The same results have been confirmed by multiple regression analyses taking into account all potential confoun-ders. No selection bias affected these results. Conclusion Theoretical and practical sessions resulted in an improved quality of examination technique than did mailed material.

Download Full-text