scholarly journals Maternal and Perinatal Outcomes of Exercise in Pregnant Women with Chronic Hypertension and/or Previous Preeclampsia: A Randomized Controlled Trial

2013 ◽  
Vol 2013 ◽  
pp. 1-8 ◽  
Author(s):  
Karina Tamy Kasawara ◽  
Camila Schneider Gannuny Burgos ◽  
Simony Lira do Nascimento ◽  
Néville Oliveira Ferreira ◽  
Fernanda Garanhani Surita ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Physical Exercise ◽  
Pregnant Women ◽  
Controlled Trial ◽  
Neonatal Outcomes ◽  
Control Group ◽  
Chronic Hypertension ◽  
Study Group ◽  
Professional Supervision ◽  
Randomized Controlled

Objectives. To evaluate the association between physical exercise supervised in pregnant women with chronic hypertension and/or previous preeclampsia and maternal and neonatal outcomes. Method. Randomized controlled trial, which included 116 pregnant women with chronic hypertension and/or previous preeclampsia, considered risk of preeclampsia development. They were divided into two groups: study group that performed physical exercise with a stationary bicycle once a week, for 30 minutes; the intensity was controlled (heart rate 20% above resting values), under professional supervision and a control group that was not engaged in any physical exercise. The data was retrieved from medical charts. Significance level assumed was 5%. Results. Women from study group performed 9.24 ± 7.03 of physical exercise sessions. There were no differences between groups comparing type of delivery and maternal outcomes, including maternal morbidity and hospitalization in intensive unit care, and neonatal outcomes, including birth weight, adequacy of weight to gestational age, prematurity, Apgar scale at first and fifth minutes, hospitalization in intensive unit care, and neonatal morbidity. Conclusions. Physical exercise using a stationary bicycle in pregnant women with chronic hypertension and/or previous preeclampsia, once a week, under professional supervision, did not interfere in the delivery method and did not produce maternal and neonatal risks of the occurrence of morbidity. This trial is registered with ClinicalTrials.gov NCT01395342.

scholarly journals Effectiveness of Antipyretic with Tepid Sponging Versus Antipyretic Alone in Febrile Children: A Randomized Controlled Trial

2018 ◽  
Vol 37 (2) ◽  
pp. 129-133
Author(s):  
Chetak Kadbasal Basavaraj ◽  
Shyamala Gowri Pocha ◽  
Ravi Mandyam Dhati
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Control Group ◽  
Study Group ◽  
Axillary Temperature ◽  
Medical College ◽  
Randomized Controlled ◽  
Significant Difference

Introduction: Fever is the most common presenting complain for which children are brought to the paediatrician.Physical methods are widely used in treating febrile children, tepid sponging being commonly practiced in hospitals along with antipyretics. The objectives of this study were to compare the effectiveness of tepid sponging and antipyretic drug versus antipyretic drug alone in febrile children.Material and Methods: This was a Randomized controlled trial done in JSS Medical College and Hospital. All children under the age of 6 months to 12 years, admitted with axillary temperature of >99oF were included in the study. A total of 500 children were included over two years study period. Children with recorded axillary temperature of >990F were randomized into control and study group by computer generated randomisation. Children in the control group received only paracetamol (15mg/kg) at 5 minutes and combined group received paracetamol and tepid sponging at five minutes. Axillary temperature was monitored every 15 minutes for a period of 2 hours in both the groups.Results: There is no significant difference in reduction of temperature between the two groups by the end of two hours. Children in combined group had a higher level of discomfort than those in only antipyretic group.Conclusion: Tepid sponging does not add to the efficacy of paracetamol in antipyresis and that addition of tepid sponging to antipyretic, results in additional discomfort for the child. This study, therefore, endorses the view that antipyretic alone without tepid sponging should be the modality of therapy in children with fever.  

scholarly journals The Effect of Writing Therapy on Anxiety in Pregnant Women: A Randomized Controlled Trial

2020 ◽  
Vol 14 (2) ◽  
Author(s):  
Maryam Montazeri ◽  
Khalil Esmaeilpour ◽  
Sakineh Mohammad-Alizadeh-Charandabi ◽  
Sevda Golizadeh ◽  
Mojgan Mirghafourvand
Keyword(s):  
Randomized Controlled Trial ◽  
Pregnant Women ◽  
Controlled Trial ◽  
Block Design ◽  
Intervention Group ◽  
Control Group ◽  
Randomized Controlled ◽  
Writing Therapy ◽  
Randomized Block Design ◽  
Significant Difference

Background: As one of the most enjoyable life experiences, pregnancy may be accompanied by many physiological and psychological changes that make women susceptible to developing mental disorders such as anxiety. Non-pharmacological methods such as writing therapy are among the ways to deal with anxiety. Objectives: The present study aimed to determine the effect of writing therapy on anxiety in women during pregnancy. Methods: This randomized controlled trial was conducted on 70 pregnant women with a gestational age between 28 - 31 weeks. The participants were assigned to an intervention group and a control group using a randomized block design. The intervention group received three in-person writing therapy-based counseling sessions and two telephone calls between the sessions, while the control group received routine pregnancy care. The Beck anxiety inventory was completed before and six weeks after the intervention. Independent t-test and ANCOVA were used for data analysis. Results: There was no significant difference between the two groups in terms of socio-demographic variables and baseline anxiety scores. Based on ANCOVA with baseline score adjustment, the mean score of anxiety was significantly lower in the intervention group than in the control group after the intervention (adjusted mean difference = -6.8; 95%CI = -4.5 to -9.1; P < 0.001). Conclusions: According to the results, writing therapy can reduce anxiety in pregnant women; however, further studies are needed before a definitive conclusion.

scholarly journals The effectiveness of preoperative individual information on reducing anxiety and pain after hysterectomy: A randomized controlled trial

2019 ◽  
Vol 10 (1) ◽  
pp. 67
Author(s):  
Hrønn Thorn ◽  
Lisbeth Uhrenfeldt
Keyword(s):  
Randomized Controlled Trial ◽  
Postoperative Pain ◽  
Controlled Trial ◽  
Anxiety Level ◽  
Preoperative Anxiety ◽  
Control Group ◽  
Study Group ◽  
Randomized Controlled ◽  
Significant Difference ◽  
Individual Information

Background and objective: Preoperative anxiety among gynecological patients is well-known and has a direct correlation with postoperative pain. By minimizing preoperative anxiety, the level of postoperative pain may decrease.  The purpose of this study was to evaluate the effect of preoperative structured information and dialogue on patients' anxiety and postoperative pain.Methods: A single-center non-blinded randomized controlled trial. Forty-six women scheduled for hysterectomy were allocated either to the study group or the control group.  The study group was given individual information at a preoperative consultation while the control group was given information at admittance. The main outcome was anxiety level and postoperative pain.Results: Forty participants (study group = 20; control group = 20) were analyzed. No statistically significant difference was found in anxiety level within the first 24 h postoperatively or in postoperative pain within four weeks between the groups.Conclusions: Preoperative individual information and dialogue did not result in significant effects in reducing anxiety level nor did it result in lower postoperative pain score.

scholarly journals Nutrition information system (SISFORNUTRIMIL) application With Online Food Record for Indonesia Pregnant Women: Protocol for Randomized Controlled Trial

2021 ◽  
Author(s):  
Mira Trisyani Koeryaman ◽  
Saseendran Pallikadavath ◽  
Isobel Ryder ◽  
Ngianga Kandala
Keyword(s):  
Randomized Controlled Trial ◽  
Pregnant Women ◽  
Dietary Diversity ◽  
Controlled Trial ◽  
Intervention Group ◽  
Eating Behaviour ◽  
Control Group ◽  
Food Record ◽  
Randomized Controlled ◽  
The Impact

Abstract Background: The pregnant women and family may not have the necessary knowledge and skills to estimate nutrient value in food in line with dietary targets and the guidelines, i.e. they do not know whether or not they are consuming the right amount of nutrition needed during pregnancy. The aims of this randomized controlled trial (RCT) is to examine the impact of SISFORNUTRIMIL application on maternal eating behaviour and associated maternal factors such as weight gain, blood pressure, biochemical measurement, and pregnancy outcome.Methods: The study recruits 112 participants with eligible criteria during December 2019 to January 2020. The allocation of participants is 1:1 to the SISFORNUTRIMIL application user and non-user application, with criteria: singleton pregnancy (22-26 weeks), mother age between 20-35 years), have monthly income and literate. Both groups will receive 12-week standard health services from health professionals and received information about dietary diversity and food record. Particularly, intervention group could be access the SISFORNUTRIMIL on their devices, which provide necessary information about nutrition in pregnancy, food record and food choice includes total serving size calculation. In contrast, the control group only receive food information and food intake record by paper-based, and they should record and calculate the nutrition intake by traditionally. Discussion: This is the first randomized controlled trial to examine the SISFORNUTIMIL application. This mandate reflects keen interest and motivation for the proposed research study. This is in addition to the researcher’s personal efforts to reduce morbidity and mortality rate as well as a general focus on pregnancy complication prevention than nutrition treatment. Thus, an investigation of eating behaviour and associated maternal needed to address this issue. Firstly, the results could extend the scope of knowledge about nutrition intervention to include the Indonesia pregnant women context as well as the Indonesia health ministry context. Secondly, this research could help to change individual health behaviour and activity undertaken by an individual who believes her-self to be healthy.Trial registration: ISRCTN Registry: ISRCTN42690828. Date of registration: 22 October 2019.

scholarly journals Effectiveness of WeChat for Improving Exclusive Breastfeeding in Huzhu County China: Randomized Controlled Trial

10.2196/23273 ◽  
2020 ◽  
Vol 22 (12) ◽  
pp. e23273
Author(s):  
Qiong Wu ◽  
Yiwen Huang ◽  
Zijun Liao ◽  
Michelle Helena van Velthoven ◽  
Wei Wang ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Pregnant Women ◽  
Exclusive Breastfeeding ◽  
Controlled Trial ◽  
Intervention Group ◽  
Mobile Technologies ◽  
Control Group ◽  
Randomized Controlled ◽  
Breastfeeding Rate ◽  
Significant Difference

Background The benefits of breastfeeding for both infants and mothers have been well recognized. However, the exclusive breastfeeding rate in China is low and decreasing. Mobile technologies have rapidly developed; communication apps such as WeChat (one of the largest social networking platforms in China) are widely used and have the potential to conveniently improve health behaviors. Objective This study aimed to assess the effectiveness of using WeChat to improve breastfeeding practices. Methods This 2-arm randomized controlled trial was conducted among pregnant women from May 2019 to April 2020 in Huzhu County, Qinghai Province, China. Pregnant women were eligible to participate if they were aged 18 years or older, were 11 to 37 weeks pregnant with a singleton fetus, had no known illness that could limit breastfeeding after childbirth, used WeChat through their smartphone, and had access to the internet. A total of 344 pregnant women were recruited at baseline, with 170 in the intervention group and 174 in the control group. Women in the intervention group received breastfeeding knowledge and promotion information weekly through a WeChat official account from their third month of pregnancy to 6 months postpartum. The primary outcome of exclusive and predominant breastfeeding rate was measured 0-1 month, 2-3 months, and 4-5 months postpartum. Results At 0-1 month postpartum, the exclusive breastfeeding rate was significantly higher in the intervention group than that in the control group (81.1% vs 63.3%; odds ratio [OR] 2.75, 95% CI 1.58-4.78; P<.001). Similarly, mothers in the intervention group were more likely to provide predominantly breast milk (OR 2.77, 95% CI 1.55-4.96; P<.001) and less likely to give dairy products to their children (OR 0.40, 95% CI 0.21-0.75; P=.005). There was no statistically significant difference for exclusive breastfeeding rate 2-3 months (P=.09) and 4-5 months postpartum (P=.27), though more children in the intervention group were exclusively breastfed than those in the control group 2-3 months postpartum (intervention: 111/152, 73.0%; control: 96/152, 63.2%) and 4-5 months postpartum(intervention: 50/108, 46.3%; control: 46/109, 42.2%). Conclusions This study is the first effort to promote exclusive breastfeeding through WeChat in China, which proved to be an effective method of promoting exclusive breastfeeding in early life. WeChat health education can be used in addition to local breastfeeding promotion programs. Trial Registration Chinese Clinical Trial Registry ChiCTR1800017364; http://www.chictr.org.cn/showproj.aspx?proj=29325 International Registered Report Identifier (IRRID) RR2-10.1186/s12889-019-7676-2

scholarly journals Save the children by treating their mothers (PriVileG-M-study) - study protocol: a sequentially randomized controlled trial of individualized psychotherapy and telemedicine to reduce mental stress in pregnant women and young mothers and to improve Child’s health

2019 ◽  
Vol 19 (1) ◽  
Author(s):  
M. Bischoff ◽  
V. Howland ◽  
J. Klinger-König ◽  
S. Tomczyk ◽  
S. Schmidt ◽  
...  
Keyword(s):  
Mental Health ◽  
Randomized Controlled Trial ◽  
Pregnant Women ◽  
Health Professionals ◽  
Mental Stress ◽  
Controlled Trial ◽  
Maternal Sensitivity ◽  
Control Group ◽  
Randomized Controlled ◽  
Ecological Momentary

Abstract Background As early as pregnancy, maternal mental stress impinges on the child’s development and health. Thus, this may cause enhanced risk for premature birth, lowered fetal growth, and lower fetal birth weight as well as enhanced levels of the stress hormone cortisol and lowered levels of the bonding hormone oxytocin. Maternal stress further reduces maternal sensitivity for the child’s needs which impairs the mother-child-interaction and bonding. Therefore, prevention and intervention studies on mental stress are necessary, beginning prenatally and applying rigorous research methodology, such as randomized controlled trials, to ensure high validity. Methods A randomized controlled trial is used to assess the impact of psychotherapy and telemedicine on maternal mental stress and the child’s mental and physical health. Mentally stressed pregnant women are randomized to an intervention (IG) and a not intervened control group. The IG receives an individualized psychotherapy starting prenatal and lasting for 10 months. Afterwards, a second randomization is used to investigate whether the use of telemedicine can stabilize the therapeutic effects. Using ecological momentary assessments and video recordings, the transfer into daily life, maternal sensitivity and mother-child-bonding are assessed. Psycho-biologically, the synchronicity of cortisol and oxytocin levels between mother and child are assessed as well as the peptidome of the colostrum and breast milk, which are assumed to be essential for the adaptation to the extra-uterine environment. All assessments are compared to an additional control group of healthy women. Finally, the results of the study will lead to the development of a qualification measure for health professionals to detect mental stress, to treat it with low-level interventions and to refer those women with high stress levels to mental health professionals. Discussion The study aims to prevent the transgenerational transfer of psychiatric and somatic disorders from the mother to her child. The effects of the psychotherapy will be stabilized through telemedicine and long-term impacts on the child’s and mothers’ mental health are enhanced. The combination of psychotherapy, telemedicine and methodologies of ecological momentary assessment, video recording and bio banking are new in content-related and methodological manner. Trial registration German Clinical Trials Register: DRKS00017065. Registered 02 May 2019. World Health Organization, Universal Trial Number: U1111–1230-9826. Registered 01 April 2019.

scholarly journals Prenatal Administration of Betamethasone and Neonatal Respiratory Distress Syndrome in Multifetal Pregnancies: A Randomized Controlled Trial

2020 ◽  
Vol 15 (2) ◽  
pp. 164-169
Author(s):  
Fatemeh Abbasalizadeh ◽  
Khadijeh Pouya ◽  
Raana Zakeri ◽  
Rana Asgari-Arbat ◽  
Shamsi Abbasalizadeh ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Premature Infants ◽  
Distress Syndrome ◽  
Controlled Trial ◽  
Intervention Group ◽  
Neonatal Outcomes ◽  
Control Group ◽  
Randomized Controlled ◽  
Neonatal Respiratory Distress ◽  
And Control

Background: Neonatal Respiratory Distress Syndrome (NRDS) is one of the most frequent causes of neonatal mortality especially in premature infants. Although it has been well established that maternal antenatal corticosteroid therapy has a positive effect on NRDS reduction, yet the effectiveness of this treatment in multifetal pregnancies is dubious. Objective: We aimed to investigate the effect of betamethasone therapy on the incidence of NRDS in multifetal pregnancies through a randomized controlled trial. Method: 140 women with a multifetal pregnancy at less than 28 weeks’ gestational age were randomly allocated into intervention and control groups. Women at the intervention group received intramuscularly betamethasone (12 mg/kg/BW twice). Neonatal outcomes were evaluated between two groups of intervention and control, and two subgroups of preterm and term births. This study is registered with the Iranian Clinical Trials Registry, number IRCT20180227038879N1. Result: The incidence of NRDS was significantly lower in infants of betamethasone group than the ones in the control group (4.9% vs 18.1%, P=0.034) while it did not show a significant reduction in preterm infants compared to mature ones. Also, the intervention group presented a significant lower neonatal ventilation than the control group (47.2% vs 63.2%, P=0.041). Other neonatal outcomes, including age at birth, birth weight, Apgar score, NICU admission, and the number of mortalities were not significantly different between study groups. Conclusion: Betamethasone therapy during 28-32 weeks of gestation in multifetal pregnancies was associated with better neonatal outcomes through significant reductions in NRDS incidence and requiring ventilator treatment. However, betamethasone administration did not reduce the chance of NRDS in premature infants.

scholarly journals A web-based dietary intervention in early pregnancy and neonatal outcomes: a randomized controlled trial

2018 ◽  
Vol 41 (2) ◽  
pp. 371-378 ◽  
Author(s):  
R A K Kennedy ◽  
C M E Reynolds ◽  
S Cawley ◽  
E O’Malley ◽  
D M McCartney ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Standard Care ◽  
Dietary Intervention ◽  
Controlled Trial ◽  
Intervention Group ◽  
Neonatal Outcomes ◽  
Dietary Behaviour ◽  
Control Group ◽  
Evidence Based ◽  
Randomized Controlled

Abstract Background Maternal nutrition is a determinant of pregnancy outcomes. Few studies have evaluated the potential of online nutrition resources to modify behaviour. This randomized controlled trial aimed to determine whether access to a customized evidence-based nutrition website in pregnancy improved neonatal outcomes. Methods Women <18 weeks gestation were recruited at their convenience. The control group received standard care. In addition to standard care, the intervention group received access to an evidence-based nutrition website, customized to the preferences of pregnant women. Results Of the 250 women, there were no differences in characteristics between the two groups. Of the women, 91.0% reported they make a conscious effort currently to eat a healthy diet. However, only 19.6% met dietary requirements for calcium, 13.2% for iron, 2.7% for folate and 2.3% for iodine. The most popular website section was pregnancy nutrition advice but engagement was not sustained. Access to the website was not associated with any improvement in clinical outcomes (P > 0.05). Conclusions We found that provision of a customized website providing nutrition information, did not improve neonatal outcomes. Future studies should explore whether redesign with website interactivity or embedding information on popular digital platforms sustains women’s engagement and modifies dietary behaviour.

scholarly journals The effect of solution-focused counseling on violence rate and quality of life of pregnant women at risk of domestic violence: a randomized controlled trial

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Sepideh Dinmohammadi ◽  
Mohsen Dadashi ◽  
Elahe Ahmadnia ◽  
Leila Janani ◽  
Roghieh Kharaghani
Keyword(s):  
Quality Of Life ◽  
Domestic Violence ◽  
Randomized Controlled Trial ◽  
Pregnant Women ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Randomized Controlled ◽  
Solution Focused

Abstract Background Domestic violence during pregnancy as one of the most common social problems and major challenges of health systems can affect the health of the mother and fetus. The study aimed to compare the two groups of intervention based on solution-focused counseling and control in terms of violence and quality of life amounts in women who had experienced domestic violence. Methods A randomized controlled trial on 90 pregnant women was blocked into two intervention groups (n = 45) and a control (n = 45). The intervention group received six counseling sessions with a solution-focused approach. Study tool included conflict tactics scale (CTS- 2) and short form health survey (SF-36). The tools were completed once before the intervention and again 6 weeks after the end of the counseling sessions by the participants of both groups. The P-value less than 0.05 was considered statistically significant. Results A total of 82/90 pregnant women were analyzed. The results showed that median and interquartile range (IQR) of physical, psychological and sexual violence significantly decreased in the intervention group than the control group (Ps = 0.001). Moreover, quality of life scores significantly improved in the intervention group compared to the control group (P = 0.001). Conclusion Solution-focused counseling could be an effective approach to reduce the amount of violence and increase the quality of life in women exposed to domestic violence. Trial registration Iranian Registry of Clinical Trials IRCT2017040628352N4. Date of registration: August 20th 2017.

Effects of Multidisciplinary Team Care Based on 5E’s Renal Rehabilitation for Peritoneal Dialysis Patients in Guangxi Zhuang Autonomous Region of China: A Randomized Controlled Trial

2019 ◽  
Vol 48 (2) ◽  
pp. 115-123 ◽  
Author(s):  
Yixin Luo ◽  
Yanlin Huang ◽  
Xiuyu  Chen ◽  
Gang  Meng ◽  
Yongsheng  Zhang
Keyword(s):  
Randomized Controlled Trial ◽  
Peritoneal Dialysis ◽  
Multidisciplinary Team ◽  
Controlled Trial ◽  
Advisory Council ◽  
Self Management ◽  
Control Group ◽  
Study Group ◽  
Randomized Controlled ◽  
Group 1

Background: The number of patients with peritoneal dialysis (PD) in China has been increasing year after year, but there are still some challenge in the management of PD patients, and the efficient and effective method has yet to be developed. Multidisciplinary team (MDT) is to create a standardized, individualized, and continuous integrated treatment program for the patients, to ensure the best efficacy and improve patient outcomes. 5E’s renal rehabilitation was originally developed by the Life Options Rehabilitation Advisory Council in 1997 to achieve better management of PD patients. However, there is still no relevant study combining these 2 methods and applying to PD patients so far. Methods: A randomized controlled trial was undertaken in the nephrology department of the First Affiliated Hospital of Guangxi Medical University. We recruited 146 patients according to inclusion and exclusion criteria and divided them into study group (n = 73) and control group (n = 73) using SPSS random number. The control group received routine care and follow-up, while the study group received MDT care based on 5E’s renal rehabilitation. The self-management scale for PD patients and the incidence of dialysis-related peritonitis were compared before discharge and 12 months after discharge. Results: T tests showed that there were no significant differences between the 2 groups in the 5 subscales of Self-management Scale for PD patients at the baseline measures (p > 0.05). However, after 12 months of intervention, the study group gained higher scores in the 5 subscales while the control group declined. And the study group improved statistically significant compared with the control group on “Solution bag replacement (t = 3.103, p = 0.002),” “Troubleshooting during operation (t = 3.978, p ≤ 0.001),” “Diet management (t = 3.201, p = 0.002),”and “Emotion management and return to social life (t = 3.552, p = 0.001)” subscales. Moreover, the peritonitis occurrence rate of the study group (1/68.1 patient month) was statistically significantly lower than that of control group (1/29.4 patient month; p = 0.047). Conclusions: MDT care based on 5E’s renal rehabilitation is beneficial for patients undergoing PD and helpful to improve self-management ability and reduce the incidence of peritonitis.

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