scholarly journals The Effect of Foot Reflexology on Sleep Quality among High Risk Pregnant Women: A Randomized Controlled Trial

2020 ◽  
Keyword(s):  
Randomized Controlled Trial ◽  
High Risk ◽  
Sleep Quality ◽  
Pregnant Women ◽  
Controlled Trial ◽  
Randomized Controlled

scholarly journals Safety and pharmacokinetics of pravastatin used for the prevention of preeclampsia in high-risk pregnant women: a pilot randomized controlled trial

2016 ◽  
Vol 214 (6) ◽  
pp. 720.e1-720.e17 ◽  
Author(s):  
Maged M. Costantine ◽  
Kirsten Cleary ◽  
Mary F. Hebert ◽  
Mahmoud S. Ahmed ◽  
Linda M. Brown ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
High Risk ◽  
Pregnant Women ◽  
Controlled Trial ◽  
Randomized Controlled ◽  
Pilot Randomized Controlled Trial

scholarly journals Walking in pregnancy and prevention of insomnia in third trimester using pedometers: study protocol of Walking_Preg project (WPP). A randomized controlled trial

2020 ◽  
Vol 20 (1) ◽  
Author(s):  
C. Amezcua-Prieto ◽  
M. Naveiro-Fuentes ◽  
N. Arco-Jiménez ◽  
R. Olmedo-Requena ◽  
R. Barrios-Rodríguez ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Randomized Controlled Trial ◽  
Sleep Quality ◽  
Pregnant Women ◽  
Controlled Trial ◽  
Intervention Group ◽  
Third Trimester ◽  
Randomized Controlled ◽  
In Pregnancy

Abstract Background Previous studies in pregnancy have not focused in evaluating the effect of walking during pregnancy and prevention of insomnia. Our general objective is to determine the effect of a walking program in preventing the appearance of insomnia in the third trimester of pregnancy, increasing sleep quality and improving quality of life throughout pregnancy. Methods Randomized Controlled trial in parallel in healthy sedentary pregnant women (n = 265), Walking_Preg Project (WPP), from university hospital in Granada, Spain. At 12th gestational week (GW), they will be invited to participate and randomly assigned to one of the three arms of study: the intervention group I1 (pedometer, goal of 11,000 steps/day), intervention group I2 (pedometer, no goal) and control (no pedometer). Duration of intervention: 13–32 GW. At 12th, 19th and 31st GW the average steps/day will be measured in groups I1 and I2. At 13th, 20th and 32nd GW, Athens Insomnia Scale (AIS), Pittsburgh Sleep Quality Index (PSQI), Adherence to Mediterranean Diet (AMD), physical activity (short IPAQ), quality of life (PSI), and consumption of toxic substances (caffeine, illegal drugs, alcohol and tobacco) will be collected. Student t test or Mann-Whitney U will be used to compare 19th and 31st GW mean of daily steps between I1 and I2 groups. To compare differences between groups in terms of frequency of insomnia/quality of life for each trimester of pregnancy, Pearson’s Chi-square test or Fisher’s exact test will be used. To determine differences in hours of sleep and quality of sleep throughout each trimester of pregnancy, analysis of variance or Friedman test will be used. McNemar-Bowker test will be used to assess differences in life quality in pre-post analyses in the 3 arms. We will use Stata 15 statistical software. Discussion promoting walking in second half of pregnancy through use of pedometer and health pre-registration of a goal to be achieved –'10,000–11,000 steps a day’– should prevent appearance of insomnia in third trimester, will increase sleep quality and quality of life in pregnant women. Trial registration ClinicalTrials.gov Identifier: NCT03735381. Registered 8th November, 2018.

scholarly journals Online prenatal trial in mindfulness sleep management (OPTIMISM): protocol for a pilot randomized controlled trial

2020 ◽  
Vol 6 (1) ◽  
Author(s):  
Ira Kantrowitz-Gordon ◽  
Susan M. McCurry ◽  
Carol A. Landis ◽  
Rachel Lee ◽  
Dahee Wi
Keyword(s):  
Randomized Controlled Trial ◽  
Sleep Quality ◽  
Pregnant Women ◽  
Outcome Measures ◽  
Mindfulness Meditation ◽  
Controlled Trial ◽  
Self Management ◽  
Secondary Outcome ◽  
Post Intervention ◽  
Randomized Controlled

Abstract Background Sleep deficiency affects a majority of pregnant women with significant impact on daily function, mood, and pregnancy and birth outcomes. This ongoing study combines two evidence-based strategies for improving sleep and mood, mindfulness meditation and cognitive-behavioral therapy for insomnia (CBT-I), in a unique online format to address the particular needs of pregnant women. The purpose of this study is to test the feasibility and estimate the efficacy of this novel 6-week online mindfulness meditation intervention to help pregnant women in remission from depression self-manage insomnia. Methods This is a two-arm, parallel group randomized controlled trial. A total of 50 pregnant women between 12 and 28 weeks gestation will be recruited from the community and randomly assigned to a mindfulness or education-only control group in a 1:1 ratio. During the study, all participants will complete six weekly online modules, daily sleep diaries, and optional participation in a treatment-specific online discussion forum. Feasibility outcome measures will include study recruitment, retention, intervention adherence (number of online modules completed, number of meditation days per week), and intervention acceptability (8-item questionnaire). The primary clinical outcome measure will be sleep quality measured with the Pittsburgh Sleep Quality Index. Secondary outcome measures will include sleep measured with actigraphy and diaries (sleep efficiency, total sleep time, total wake time), Patient-Reported Outcomes Measurement Information System (PROMIS) measures (fatigue, sleep-related impairment, sleep disturbance); mood (depression, anxiety, positive affect, quality of life); and self-management and behavior change (potential self-efficacy, self-regulation, sleep problem acceptance, and trait mindfulness). Assessments will occur at baseline and post-intervention; an additional acceptability survey will be completed 4 weeks postpartum. Analyses will examine within-group differences in outcome change scores from baseline to post-intervention. Open-ended feedback will be analyzed using qualitative content analysis. Discussion This research is innovative in addressing sleep in pregnancy using a self-management research design and methods that can be accessible and cost-effective for large numbers of pregnant women. The results from this study will inform intervention refinement and efficacy testing of the intervention in a larger randomized controlled trial. Trial registration ClinicalTrials.gov, NCT04016428. Registered on 11 July 2019. Updated version registered on 26 July 2019.

scholarly journals Effect of Nurse Home Visits vs. Usual Care on Reducing Intimate Partner Violence in Young High-Risk Pregnant Women: A Randomized Controlled Trial

PLoS ONE ◽  
2013 ◽  
Vol 8 (10) ◽  
pp. e78185 ◽  
Author(s):  
Jamila Mejdoubi ◽  
Silvia C. C. M. van den Heijkant ◽  
Frank J. M. van Leerdam ◽  
Martijn W. Heymans ◽  
Remy A. Hirasing ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Intimate Partner Violence ◽  
High Risk ◽  
Usual Care ◽  
Pregnant Women ◽  
Partner Violence ◽  
Controlled Trial ◽  
Intimate Partner ◽  
Nurse Home ◽  
Randomized Controlled

scholarly journals Effect of Oral Prophylactic Measures on the Occurrence of Pre-Eclampsia (OP-PE) in High-Risk Pregnant Women: A Cluster Randomized Controlled Trial

2021 ◽  
Vol 4 (3) ◽  
pp. 61
Author(s):  
Aida Kanoute ◽  
Jocelyne Gare ◽  
Nicolas Meda ◽  
Stephane Viennot ◽  
Paul Tramini ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
High Risk ◽  
Pregnant Women ◽  
Oral Hygiene ◽  
Controlled Trial ◽  
Cluster Randomized Controlled Trial ◽  
Oral Microbiome ◽  
Randomized Controlled ◽  
Prophylactic Measures ◽  
Cluster Randomized

Pre-eclampsia (PE), a pregnancy-specific hypertensive disorder, characterized by the development of placental endothelial dysfunction, remains a major source of maternal and perinatal morbidity and mortality, especially in low- and middle-income settings. Periodontal disorders during pregnancy, and particularly periodontal pathogens, may be related to the risk of PE. Standard oral hygiene methods, based mainly on the joint use of toothbrushes and interdental brushes, reduce periodontal inflammatory risk and modulate the dysbiosis of the oral microbiome. The aim of this trial is to compare the PE outcomes in high-risk pregnant women receiving oral prophylactic measures to a control group. This trial is designed as a two-arm, parallel, cluster randomized controlled trial with the antenatal obstetric clinic as the unit of randomization and an allocation ratio of 1:1. The pregnant women will be included at 3 months of pregnancy and will be followed throughout the pregnancy. The primary outcome measure will be the incidence of PE from a baseline during the pregnancy. Secondary outcomes measures will include changes from the baseline in quantification of the pathogenic bacterial load of the interdental microbiota, the severity scores of periodontal indicators, and the incidence of adverse perinatal outcomes. This trial should demonstrate that the implementation of daily oral hygiene reduces oral dysbiosis, the incidence of periodontal disease, and the risk of PE.

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