Influence of a Virtual Exercise Program throughout Pregnancy during the COVID-19 Pandemic on Perineal Tears and Episiotomy Rates: A Randomized Clinical Trial

The complications associated with COVID-19 confinement (impossibility of grouping, reduced mobility, distance between people, etc.) influence the lifestyle of pregnant women with important associated complications regarding pregnancy outcomes. Therefore, perineal traumas are the most common obstetric complications during childbirth. The aim of the present study was to examine the influence of a supervised virtual exercise program throughout pregnancy on perineal injury and episiotomy rates during childbirth. A randomized clinical trial design (NCT04563065) was used. Data were collected from 98 pregnant women without obstetric contraindications who attended their prenatal medical consultations. Women were randomly assigned to the intervention (IG, N = 48) or the control group (CG, N = 50). A virtual and supervised exercise program was conducted from 8–10 to 38–39 weeks of pregnancy. Significant differences were found between the study groups in the percentage of episiotomies, showing a lower episiotomy rate in the IG (N = 9/12%) compared to the CG (N = 18/38%) (χ2 (3) = 4.665; p = 0.031) and tears (IG, N = 25/52% vs. CG, N = 36/73%) (χ2 (3) = 4.559; p = 0.033). A virtual program of supervised exercise throughout pregnancy during the current COVID-19 pandemic may help reduce rates of episiotomy and perineal tears during delivery in healthy pregnant women.

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Influence of a Water-Based Exercise Program in the Rate of Spontaneous Birth: A Randomized Clinical Trial

International Journal of Environmental Research and Public Health ◽

10.3390/ijerph17030795 ◽

2020 ◽

Vol 17 (3) ◽

pp. 795

Author(s):

Raquel Rodríguez-Blanque ◽

María José Aguilar-Cordero ◽

Ana Eugenia Marín-Jiménez ◽

Ana María Núñez-Negrillo ◽

Antonio Manuel Sánchez-López ◽

...

Keyword(s):

Clinical Trial ◽

Physical Exercise ◽

Pregnant Women ◽

Randomized Clinical Trial ◽

Exercise Program ◽

Exercise Group ◽

Normal Weight ◽

Control Group ◽

Water Based ◽

Spontaneous Delivery

Introduction: Many women change their lifestyles and habits when they become pregnant, to avoid potentially harmful effects to themselves and their babies. This is especially so with respect to physical exercise, which is often greatly reduced due to ignorance of the benefits it provides during pregnancy. Aim: To evaluate the prevalence of spontaneous birth among women who participated in a water-based physical exercise program. Methods: A randomized clinical trial was conducted with a sample of 129 pregnant women (Control Group, CG = 64; Exercise Group, EG = 65). A physical exercise protocol, specifically designed for pregnant women, was created and applied. Those in the EG performed 60 min exercise sessions, three times per week for 17 weeks. The participants in the CG received routine check-ups and advice throughout their pregnancy. Findings: The women in the EG presented better results for the onset of spontaneous birth (OR = 2.060 (0.980–4.332)) and for neonate Apgar score of 10 at five minutes (OR = 8.53 (3.60–20.17)). Those who had normal weight at the start of pregnancy achieved better results for spontaneous delivery (OR = 2.099 (1.017–4.335)) than those with overweight/obesity. The rate of caesarean delivery was higher in the women with overweight/obesity (OR = 3.570 ((1.226–10.397)) than in those with normal weight. Conclusions: In our study, the women who followed the water-based exercise program gained less weight during pregnancy, which facilitated a better rate of spontaneous, non-instrumental childbirth, together with a better Apgar test score at five minutes.

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Effectiveness of a Virtual Exercise Program During COVID-19 Confinement on Blood Pressure Control in Healthy Pregnant Women

Frontiers in Physiology ◽

10.3389/fphys.2021.645136 ◽

2021 ◽

Vol 12 ◽

Author(s):

Cristina Silva-Jose ◽

Miguel Sánchez-Polán ◽

Ángeles Diaz-Blanco ◽

Javier Coterón ◽

Ruben Barakat ◽

...

Keyword(s):

Blood Pressure ◽

Pregnant Women ◽

Exercise Program ◽

Clinical Trial Design ◽

Pressure Control ◽

Study Groups ◽

Maternal Blood ◽

Cardiovascular Complications ◽

Control Group ◽

Maternal Blood Pressure

BackgroundThe situation caused by COVID-19 has led to movement restrictions for the majority of the population due to the confinement established by the health authorities. This new situation has changed people’s habits and significantly affected the pregnant population. Decreased exercise and increased psychophysical stress are associated with excessive weight gain, diabetes, and gestational cardiovascular complications that affect the mother, fetus, and newborn. Recent research shows that the dynamics of maternal blood pressure is one of the most important control factors during pregnancy. Thus, prevention of these type of pathologies through interventions without maternal-fetal risks is important.ObjectivesTo examine the influence of a virtual exercise program on maternal blood pressure during pregnancy.Materials and MethodsA randomized clinical trial design was used (NCT04563065). Data from 72 pregnant women without obstetric contraindications under confinement conditions in the Madrid area were collected. Women were randomly assigned to the intervention (IG) or control group (CG). They previously signed informed consent forms. A moderate exercise program was performed as an intervention from 8–10 to 38–39 weeks of pregnancy. Systolic (SBP) and diastolic (DBP) maternal blood pressure were measured during the first, second and third trimesters of pregnancy, as well as before and immediately after delivery in both study groups.ResultsNo differences in systolic and diastolic blood pressure during the first, second and third trimesters were found between groups. Significant differences in SBP were found immediately before delivery (IG = 119.83 ± 10.16 vs. CG = 125.6 ± 10.91; p = 0.047) and immediately after delivery (IG = 115.00 ± 11.18 vs. CG = 122.24 ± 15.71; p = 0.045).ConclusionsResults show lower SBP values for the IG during delivery than CG. A virtual exercise program throughout pregnancy during COVID-19 confinement can help to control systolic blood pressure before and immediately after delivery in healthy pregnant women.

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Does Exercise During Pregnancy Affect Placental Weight?: A Randomized Clinical Trial

Evaluation & the Health Professions ◽

10.1177/0163278717706235 ◽

2017 ◽

Vol 41 (3) ◽

pp. 400-414 ◽

Cited By ~ 3

Author(s):

Ruben Barakat ◽

Marina Vargas ◽

Maia Brik ◽

Irene Fernandez ◽

Javier Gil ◽

...

Keyword(s):

Pregnant Women ◽

Exercise Program ◽

Study Groups ◽

Normal Pregnancy ◽

Exercise Group ◽

Placental Weight ◽

Control Group ◽

Placental Function ◽

Supervised Exercise ◽

Exercise During Pregnancy

Placental weight (PW) is a measure commonly used to summarize growth and aspects of placental function. In a normal pregnancy, it is reasonable to assume that PW is related to aspects of the functional capacity of the placenta. The placenta, as the site for all maternal–fetal oxygen and nutrient exchange, influences birth weight and is thus central to a successful pregnancy outcome. PW is the most common way to characterize placental growth, which relates to placental function. With physical exercise becoming an integral part of life for many women, the question of whether exercise during pregnancy has an adverse effect on the growing fetus is very important. The aim was to examine the influence of an aerobic exercise program throughout pregnancy on PW among healthy pregnant women. A randomized control trial was used (registration trial number: NCT02420288). Women were randomized into an exercise group (EG; n = 33) or a control group (CG; n = 32) that received standard care. The EG trained 3 days/week (55–60 min/session) from gestational Weeks 9–11 until Weeks 38–39. The 85 training sessions involved aerobic, muscular and pelvic floor strength, and flexibility exercises. PW and other pregnancy outcomes were measured. There was high attendance to the exercise program, and no differences in the PW at delivery were observed between study groups (CG = 493.2 ± 119.6 g vs. EG = 495.4 ± 150 g, p = .95). A regular, supervised exercise program throughout pregnancy does not affect the PW in healthy pregnant women.

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A randomized clinical trial on the effects of remote intercessory prayer in the adverse outcomes of pregnancies

Ciência & Saúde Coletiva ◽

10.1590/s1413-81232013000800022 ◽

2013 ◽

Vol 18 (8) ◽

pp. 2379-2384 ◽

Cited By ~ 4

Author(s):

Maria Inês da Rosa ◽

Fabio Rosa Silva ◽

Bruno Rosa Silva ◽

Luciana Carvalho Costa ◽

Angela Mendes Bergamo ◽

...

Keyword(s):

Clinical Trial ◽

Pregnant Women ◽

Randomized Clinical Trial ◽

Care Service ◽

Health Care Service ◽

Adverse Outcomes ◽

Public Health Care ◽

Intercessory Prayer ◽

Control Group ◽

Double Blind

The scope of this article was to investigate whether intercessory prayer (IP) influences the adverse outcomes of pregnancies. A double-blind, randomized clinical trial was conducted with 564 pregnant women attending a prenatal public health care service. The women were randomly assigned to an IP group or to a control group (n = 289 per group). They were simultaneously and randomly assigned to practice prayer off-site or not. The following parameters were evaluated: Apgar scores, type of delivery and birth weight. The mean age of the women was 25.1 years of age (± 7.4), and the average gestational age was 23.4 weeks (± 8.1). The average number of years of schooling for the women was 8.1 years (± 3.1). The women in the IP and control groups presented a similar number of adverse medical events with non-significant p. No significant differences were detected in the frequency of adverse outcomes in pregnant women who practiced IP and those in the control group.

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Educational workshops about bonding with the fetus during pregnancy: a clinical trial

Revista Gaúcha de Enfermagem ◽

10.1590/1983-1447.2021.20200330 ◽

2021 ◽

Vol 42 ◽

Author(s):

Priscila Costa ◽

Paula Rosenberg de Andrade ◽

Bruna Arends Roschel Tomaz ◽

Samara Macedo Cordeiro ◽

Danielle Castro Jansen ◽

...

Keyword(s):

Clinical Trial ◽

Child Development ◽

Usual Care ◽

Pregnant Women ◽

Randomized Clinical Trial ◽

Gestational Age ◽

Health Clinic ◽

Control Group ◽

Before And After ◽

Experimental Group

ABSTRACT Objective: To verify if participation in educational workshops about bonding with the fetus influences the adoption of practices of interaction with the baby by pregnant women. Method: Randomized clinical trial conducted in a health clinic. The experimental group participated in educational workshops designed for the pregnant couple and the control group received usual care. The practices of interaction with the fetus were evaluated before and after the intervention. Results: 19 pregnant women participated in the study. There was a positive correlation between higher gestational age and the interaction with the fetus (p = 0.016), and between younger mothers and the practice of touching or poking the baby (p = 0.019). There was an increase in the interaction with the fetus in the control and experimental groups (p= 0.024). Conclusion: Educational workshops are strategies for sharing knowledge about fetuses' sensory skills and to foster bonding and child development since pregnancy.

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Effect of Mindfulness Sessions on Chronic Fatigue Syndrome and Job Satisfaction of Nurses: A Randomized Clinical Trial

10.21203/rs.3.rs-567623/v1 ◽

2021 ◽

Author(s):

Nasrin Bonakdari ◽

Nadereh Mohammadi ◽

Mohammad Reza Taghvizadeh Yazdi ◽

Reza Norouzadeh ◽

Mohammad Abbasinia ◽

...

Keyword(s):

Job Satisfaction ◽

Clinical Trial ◽

Chronic Fatigue Syndrome ◽

Randomized Clinical Trial ◽

Intervention Group ◽

Clinical Trial Design ◽

Well Being ◽

Chronic Fatigue ◽

Control Group ◽

Fatigue Syndrome

Abstract Background: Nursing is considered a stressful profession, so nurses are at higher risk of physical and mental illness. Mindfulness is an important concept for nursing with practical implications for nurse well-being, development, and quality nursing care sustainability.Objectives: This study identified mindfulness sessions' effect on nurses' chronic fatigue syndrome(CFS) and job satisfaction )JS.(Methods: A randomized clinical trial design was conducted on 80 nurses to intervention and control groups. The intervention in the intervention group was eight mindfulness sessions training, and the control group had no intervention. Nurses' CFS and JS were assessed using the Minnesota Satisfaction Questionnaire and The Multidimensional Fatigue Inventory.Results: After implementing a mindfulness-based stress reduction program, the intervention group nurses reported lower CFS and higher JS than the control group(p<0.005). Conclusion: The findings of this study indicate the effectiveness of mindfulness programs on improving nurses' chronic fatigue and JS. Since CFS and job dissatisfaction are two disturbing elements for nurses' optimal performance in professional and personal life, this study can recommend the implementation of mindfulness exercises as a routine, operational and uncomplicated program in nurses.

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Fluoxetine for Anterior Ischemic Optic Neuropathy (AION); a Double Blind Randomized Clinical Trial

10.21203/rs.3.rs-179574/v1 ◽

2021 ◽

Author(s):

Mohammad Hossein Abbasi ◽

Shahnaz Rimaz ◽

Zahra Pourmousa ◽

Leila Janani ◽

Mostafa Soltan Sanjari

Keyword(s):

Clinical Trial ◽

Randomized Clinical Trial ◽

Optic Neuropathy ◽

Study Groups ◽

Anterior Ischemic Optic Neuropathy ◽

Control Group ◽

Ischemic Optic Neuropathy ◽

Double Blind ◽

Clinical Prognosis ◽

Before And After

Abstract Background: Fluoxetine enhances the levels of brain-derived neurotrophic factor (BDNF); considering its known improving effects on neurogenesis and plasticity, it seems to improve the Anterior Ischemic Optic Neuropathy (AION). This study aimed to evaluate the effect of Fluoxetine on clinical prognosis of patients with AION.Methods: In this double-blind placebo-controlled randomized clinical trial, subjects with AION who were referred to Rasool Akram Hospital were divided into two study groups; the fluoxetine group that received 20 mg Fluoxetine daily(n=50) and the control group (n=50) that received placebo for a period of six months. Patients underwent clinical and paraclinical evaluations before and after the trial. This study was a registered trial with IRCT code IRCT20181109041596N1.Results: One hundred patients were enrolled from August 2019 to December 2020 and assessed in this study. Subjects in Fluoxetine group showed significant improvement in visual acuity in comparison to the placebo group with less score in LogMAR scale (P: 0.008 and 0.002, respectively), improvement in MD parameters of perimetry (P: 0.003 and 0.002, respectively), and decrease in VEP latencies (P (in 1st minute): <0.001 and <0.001, P (in 15st minute): 0.038 and 0.011, respectively). There were no differences in color vision, Rnfl in all dimensions, PSD parameter of perimetry or VEP amplitudes following the trial of Fluoxetine therapy (Ps> 0.05).Conclusion: Fluoxetine showed promising therapeutic value for patients with AION besides its safety as an additive treatment option to corticosteroids.

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Supervised exercise protocol for lower limbs in subjects with chronic venous disease: an evaluator-blinded, randomized clinical trial

Trials ◽

10.1186/s13063-020-04314-1 ◽

2020 ◽

Vol 21 (1) ◽

Author(s):

Esther Fernandes Tinoco Volpe ◽

Vanessa R. Resqueti ◽

Ana Aline Marcelino da Silva ◽

Lucien Peroni Gualdi ◽

Guilherme A. F. Fregonezi

Keyword(s):

Clinical Trial ◽

Randomized Clinical Trial ◽

Exercise Program ◽

Calf Muscle ◽

Lower Limbs ◽

Muscle Endurance ◽

Randomized Controlled ◽

Supervised Exercise ◽

Supervised Exercise Program ◽

Calf Muscles

Abstract Background Chronic venous insufficiency (CVI) causes pathophysiological changes in the lower-limb muscles, particularly the calf muscles, and limits ankle range of motion (ROM). These changes reduce functional activities and decrease quality of life (QOL). Although several studies have shown the benefits of exercise (strengthening the calf muscles to improve calf-muscle pumping and QOL) in patients with CVI, few studies are randomized controlled trials. This has led to a weak indication of exercise for the treatment of patients with CVI. The aim of this study is to analyze the effects of a supervised exercise program to improve calf-muscle endurance as well as QOL in patients with CVI. Methods/design This is an evaluator-blind, randomized clinical trial with an 8-week duration and a follow-up evaluation at week 16. A pilot study with subjects with a CVI diagnosis will be performed to calculate sample size. The participants will be randomly allocated (1:1) into a treatment or a control group (usual care/no intervention). The treatment intervention consists of a bi-weekly supervised exercise program of the lower limbs that will include aerobic training, strengthening and cardiovascular exercises. The participants from both groups will participate in a health education lecture. Primary outcomes are changes in calf-muscle endurance and QOL score. Secondary outcomes are changes in exercise capacity, ankle ROM, electrical muscle activity and cardiac output. The first statistical comparison will be performed after 8 weeks’ intervention. Discussion Patients with CVI may have an impaired calf-muscle pump and decreased exercise capacity. A randomized controlled trial evaluating a supervised exercise program should provide much needed information on the management of CVI to promote health and independence. Trial registration This study was registered on the Brazilian Clinical Trials Database (REBEC) (RBR-57xtk7). The results will be disseminated at scientific events, presentations, and publications in peer-reviewed journals.

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Comparing Efficacy of Cerclage and Adjunctive Therapy (Cerclage & Pessary) in Prevention of Preterm Birth in Pregnant Women with Cervical Insufficiency: A Randomized Clinical Trial.

10.21203/rs.3.rs-80050/v1 ◽

2020 ◽

Author(s):

Mitra Arjmandifar ◽

Maryam Moshfeghi ◽

Maryam Mohammadi ◽

Mahya Eftekhari

Keyword(s):

Clinical Trial ◽

Survival Analysis ◽

Preterm Birth ◽

Pregnant Women ◽

Randomized Clinical Trial ◽

Gestational Age ◽

Adjunctive Therapy ◽

Intervention Group ◽

Control Group ◽

Cervical Insufficiency

Abstract Background: Cervical insufficiency is the responsible factor for 15-25% of pregnancy loss in the second trimester. Midwifery specialists sometimes prefer to use adjunctive therapy in combination with cerclage surgery for management of cervical insufficiency. The aim of this study was to evaluate the effectiveness of adjunctive pessary therapy after cerclage in improving perinatal and neonatal outcome and increasing satisfaction in women with cervical insufficiency.Methods: This concurrent randomized clinical trial was conducted at the infertility department of Royan Institute, Tehran, Iran from May 2018 to May 2020. In this trial, 170 singleton pregnant women, diagnosed with cervical insufficiency, of gestational age 14 to 26 weeks, were enrolled. Patients were randomized 1:1 to receive either cervical cerclage or pessary after cerclage. The primary outcomes were gestational age at the time of delivery and the percentage of preterm labor (<37 weeks). The secondary outcomes were the method of delivery, neonatal outcomes, maternal adverse events and maternal satisfaction of interventions.Results: Preterm birth before 37 weeks of gestation occurred in 16 women (19.3%) in the pessary group and 17 women (21%) in the control group (between-group difference, 1.11%; 95%CI 0.518−2.388%). In the survival analysis to 37 WK of gestation, the incidence of preterm birth was not significantly different between the two groups (Relative Risk (RR), 1; 95%CI, 0.161-6.202). Based on survival analysis, the incidence of vaginal bleeding and pelvic pain significantly differed between the two groups (RR, 2.68; 95%CI (1.31-5.46)) and (RR, 1.73; 95%CI (1.04-2.87), respectively. The mean score of satisfaction in the intervention group (5.73) was significantly higher than the control group (5.25), (between-group difference, 0.47; 95%CI (0.10-0.84).Conclusions: The placement of an adjunctive pessary for pregnant women with singleton pregnancy and a cervical insufficiency, did not result in a lower rate of preterm delivery before 37 weeks of gestation compared to cerclage alone. However, the complications of pregnancy after the intervention until delivery, were less in these women, while the level of satisfaction was higher. Trial registration: Iranian Registry of Clinical Trials (IRCT20180302038914N1), May 5,2018.

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Educational intervention with serial album about pregnant women positioning for spinal anesthesia: randomized clinical trial

Revista Brasileira de Enfermagem ◽

10.1590/0034-7167-2019-0878 ◽

2020 ◽

Vol 73 (suppl 4) ◽

Author(s):

Sarah de Lima Pinto ◽

Larissa Alves Sampaio ◽

Nelson Miguel Galindo Neto ◽

Paulo César de Almeida ◽

Mirna Fontenele de Oliveira ◽

...

Keyword(s):

Clinical Trial ◽

Pregnant Women ◽

Spinal Anesthesia ◽

Randomized Clinical Trial ◽

Educational Intervention ◽

Intervention Group ◽

Maternity Hospital ◽

Control Group ◽

Chi Square ◽

Exact Test

ABSTRACT Objective: To evaluate effectiveness of using educational intervention serial album to positioning pregnant women for spinal anesthesia. Method: Randomized clinical trial with 90 women casually assigned to control (CG) and intervention group (IG), in a maternity hospital located in Northeast region of Brazil. The primary endpoint was “achieve correct positioning to perform spinal anesthesia”; and secondary, “how number of spinal cord puncture attempts”. Effectiveness was verified using the chi-square test, Fisher’s exact test and likelihood ratio. Results: The positioning was correct in 37 women in each group. There was an association between women in control group remaining still, relaxing shoulders and flexing the spine; and women in intervention group should remain still and relax the shoulders; furthermore there was a statistical association achieved by correct positioning and the number of attempts to access the lumbar puncture. Conclusion: Educational intervention with serial album was effective and contributed to immobility and positioning of pregnant women. Brazilian Registry of Clinical Trials (RBR-3Z7SRD).

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