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

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.

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

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.

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

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).

scholarly journals Viable Extreme Preterm Birth and Some Neonatal Outcomes in Double Cerclage versus Traditional Cerclage: A Randomized Clinical Trial

2011 ◽  
Vol 11 ◽  
pp. 1660-1666 ◽  
Author(s):  
Farzaneh Broumand ◽  
Fatemeh Bahadori ◽  
Tahereh Behrouzilak ◽  
Zahra Yekta ◽  
Farkhondeh Ashrafi
Keyword(s):  
Clinical Trial ◽  
Preterm Birth ◽  
Randomized Clinical Trial ◽  
Gestational Age ◽  
Preterm Labor ◽  
Absolute Risk ◽  
Absolute Risk Reduction ◽  
University Hospital ◽  
Control Group ◽  
The Difference

The pregnant women at higher risk of preterm labor, referred to the perinatal clinic of Kosar University Hospital in Urmia district of Iran, were enrolled into a parallel randomized clinical trial. In the investigational arm of the clinical trial, a double cervical cerclage procedure was performed addition to McDonald cerclage. In the control group however, only McDonald cerclage was performed. Extreme preterm labor (GA < 33 weeks) was the primary endpoint of this clinical trial. Age, gestational age at cerclage time, and gravidity were not found to be statistically different between the groups. Means of gestational age were 37.4 and 36.2 weeks, respectively, for the investigational and control groups. The gestational age was 1.2 weeks longer for double cerclage group but the difference was not found to be statistically significant. Preterm birth before 33 weeks of gestation was not experienced by any of the patients who received double cerclage, but five women in control group developed such an extreme preterm labor (). The absolute risk reduction in using double cerclage over traditional method was 18 percent (95% confidence interval, 4%–32%). Double cerclage appeared to have higher efficacy than traditional cerclage in preventing preterm labor <33 weeks of gestation.

Effects of a diuretic adjustment algorithm protocol on heart failure admissions: A randomized clinical trial

2021 ◽  
pp. 1357633X2110096
Author(s):  
Maria KEF Feijó ◽  
Karen Brasil Ruschel ◽  
Daniela Bernardes ◽  
Eduarda B Ferro ◽  
Luis E Rohde ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Emergency Department ◽  
Randomized Clinical Trial ◽  
Intervention Group ◽  
Heart Association ◽  
Functional Class ◽  
Emergency Department Visits ◽  
Control Group ◽  
Point Change ◽  
Clinical Instability

Introduction The aim of this study was to evaluate the effectiveness of a diuretic adjustment algorithm (DAA) in maintaining clinical stability and reducing HF readmissions using telemonitoring Technologies. Methods Randomized clinical trial of patients with an indication for furosemide dose adjustment during routine outpatient visits. In the intervention group (IG), the diuretic dose was adjusted according to the DAA and the patients received telephone calls for 30 days. In the control group (CG), the diuretic dose was adjusted by a physician at baseline only. Co-primary outcomes were hospital readmission and/or emergency department visits due to decompensated HF within 90 days, and a 2-point change in the Clinical Congestion Score and/or a deterioration in New York Heart Association functional class within 30 days. Results A total of 206 patients were included. Most patients were male ( n=119; 58%), with a mean age of 62 (SD 13) years. Four patients (2%) in the IG and 14 (7%) in the CG were hospitalized for HF (odds ratio (OR) 0.31 (0.10–0.91); p=0.04). Multivariate analysis showed a reduction of 67% in readmissions and/or emergency department visits due to decompensated HF in the IG compared with the CG (95% CI 0.13–0.88; p=0.027). Regarding the combined outcome of HF readmission and/or emergency department visits or clinical instability, the IG had 20% fewer events than the CG within 30 days (IG: n=48 (23%), CG: n=70 (34%); OR 0.80 (0.63–0.93); p=0.03). Discussion Using DAA improved the combined outcome in these outpatients, with favorable and significant results that included a reduction in HF admissions and in clinical instability. (NCT02068937)

The effect of ear acupressure medicine at the “Shen Men” point on the nausea and vomiting during pregnancy

2021 ◽  
Vol 15 (5) ◽  
pp. 1774-1779
Author(s):  
Sanaz Nehbandani ◽  
Hajar Salehi ◽  
Khadije Rezaie Keikhaie ◽  
Hossein Rashki Ghalenow ◽  
Fatemeh Mirzaie ◽  
...  
Keyword(s):  
Pregnant Women ◽  
Gestational Age ◽  
Intervention Group ◽  
Nausea And Vomiting ◽  
Control Group ◽  
Health Clinics ◽  
Significant Difference ◽  
Quasi Experimental ◽  
The Mean ◽  
The Difference

Introduction & Objective: Nausea and vomiting during pregnancy is one of the most common gastrointestinal disorders that more than 85% of pregnant women experience. However, controlling and treating this complication is still one of the most important issues in antenatal care. Therefore, the aim of this study was to investigate the effect of ear acupressure at Shen Men point on relieving nausea, vomiting and retching during pregnancy. Materials and Methods: In this quasi-experimental study, 100 pregnant women with a gestational age of less than 16 weeks attending the health clinics of Zabol city during 2019-2020 were studied in two control and intervention groups (n = 50 in each group). The samples in the intervention group were trained to apply pressure on their ears’ Shen Men point with the thumb for three minutes three times a day (morning, noon, and night), for a duration of one month. At the end of second and fourth weeks, the data were collected using the Rhodes index form and then, were analyzed by SPSS software version 22. Results: According to the results, there was no significant difference between the two groups in terms of age, gestational age, occupation and education. The difference in the mean scores of nausea, vomiting and retching was not statistically significant between the control and intervention groups before the study. But four weeks after the study, a significant difference was observed in the mean scores of vomiting, nausea and retching between the two groups, so that the mean scores of vomiting, nausea and retching were significantly lower in the intervention group than in the control group. Conclusion: The ear acupressure medicine at the Shen men point can be used as a non-invasive, safe and inexpensive method to relieve nausea, vomiting and retching during pregnancy. Keywords: Acupressure medicine, Shen Men, Vomiting, Pregnancy, Nausea, Retching, Rhodosis

Effect of prenatal recommendations of Traditional Persian Medicine on obstetric outcomes: a randomized clinical trial

2018 ◽  
Vol 15 (3) ◽  
Author(s):  
Mansoor Keshavarz ◽  
Maryam Kashanian ◽  
Soodabeh Bioos ◽  
Yasaman Vazani
Keyword(s):  
Clinical Trial ◽  
Randomized Clinical Trial ◽  
Intervention Group ◽  
Active Phase ◽  
Obstetric Outcomes ◽  
Control Group ◽  
Control Groups ◽  
Persian Medicine ◽  
Traditional Persian Medicine ◽  
And Control

Abstract Background Traditional Persian Medicine (TPM) is an ancient medical system that provides suggestions to improve the health of mothers and children during pregnancy and labor. Persian physicians believed that these instructions made labor easier, safer, and less painful. Methods The present randomized clinical trial was conducted among women at 33–38 weeks of pregnancy in Tehran, Iran. TPM instructions consisted of diet, bathing, and application of oil from the 38th week of pregnancy to the onset of labor. The primary outcome was the duration of the active phase of labor. Results The mean duration of the active phase was 331.60 ± 151.48 min for the intervention group and 344.40 ± 271.46 min for the control groups, but it was not statistically significant. The active phase was significantly shorter in women who had better compliance (p=0.03). The need for oxytocin augmentation was 53.3% in the control group and 38.5% in the intervention group (p=0.17). The rate of perineal infection was 13% in the control group and 0% in the intervention group (p=0.11). Conclusions The active phase was not different in the intervention and control groups, but it was shorter in compliant women. It is possible that prolonged use of these recommendations in combination with a sitz baths and a larger sample size could result in more significant outcomes.

scholarly journals The Effect of Support Surfaces on the Incidence of Pressure Injuries in Critically Ill Patients: A Randomized Clinical Trial

2018 ◽  
Vol 2018 ◽  
pp. 1-6 ◽  
Author(s):  
Wesley Henrique Bueno de Camargo ◽  
Rita de Cassia Pereira ◽  
Marcos T. Tanita ◽  
Lidiane Heko ◽  
Isadora C Grion ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Randomized Clinical Trial ◽  
Critically Ill ◽  
Critically Ill Patients ◽  
Intervention Group ◽  
Control Group ◽  
Support Surface ◽  
Intention To Treat ◽  
Support Surfaces ◽  
Effect Of Support

Purpose. To analyze whether a viscoelastic mattress support surface can reduce the incidence of stage 2 pressure injuries compared to a standard hospital mattress with pyramidal overlay in critically ill patients. Method. A randomized clinical trial with intention-to-treat analysis was carried out recruiting patients with Braden scale ≤14 on intensive care unit admission from April 2016 to April 2017. Patients were allocated into two groups: intervention group (viscoelastic mattress) and control group (standard mattress with pyramidal overlay). The level of significance adopted was 5%. Results. A total of 62 patients were included in the study. There was a predominance of males (53%) and the mean age was 67.9 (SD 18.8) years. There were no differences in clinical or severity characteristics between the patients in the control group and the intervention group. Pressure injuries occurred in 35 patients, with a median time of 7 days (ITQ 4–10) from admission. The frequency of pressure injuries was higher in the control group (80.6%) compared to the intervention group (32.2%; p<0.001). Conclusions. Viscoelastic support surfaces reduced the incidence of pressure injuries in moderate or higher risk critically ill patients when compared to pyramidal support surfaces.

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

2013 ◽  
Vol 18 (8) ◽  
pp. 2379-2384 ◽  
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.

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

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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