scholarly journals Adverse Effects of Carbetocin versus Oxytocin in the Prevention of Postpartum Haemorrhage after Caesarean Section: A Randomized Controlled Trial

2018 ◽  
Vol 2018 ◽  
pp. 1-6 ◽  
Author(s):  
D. Mannaerts ◽  
L. Van der Veeken ◽  
H. Coppejans ◽  
Y. Jacquemyn
Keyword(s):  
Heart Rate ◽  
Randomized Controlled Trial ◽  
Caesarean Section ◽  
Blood Loss ◽  
Controlled Trial ◽  
Hypotensive Effect ◽  
Randomized Controlled ◽  
Significant Difference ◽  
Effect Difference ◽  
The Difference

Purpose. To compare the incidence of nausea, vomiting, and arterial hypotension between carbetocin and oxytocin to prevent haemorrhage after caesarean section (CS).Methods. A randomized controlled trial in term pregnant women undergoing planned CS. Groups were randomized to carbetocin or oxytocin. Blood pressure (BP), heart rate, presence of nausea/vomitus, and need for vasopressors were evaluated throughout surgery. Preoperative and postoperative haemoglobin and haematocrit levels were compared.Results. Fifty-eight women were randomized (carbetocinn=32; oxytocinn=26). Both medications had hypotensive effect, difference in BP for carbetocin versus oxytocin: systolic (14.4 ± 2.4 mmHg versus 8.5 ± 1.8 mmHg); diastolic (7.8 ± 1.6 mmHg versus 8.9 ± 3.0 mmHg) without significant difference between the drugs (p=0.1andp=0.7). Both groups had similar needs for vasopressors. The presence of nausea was not rare, but the difference was not statistically significant (p=0.4). Average blood loss was slightly lower in the carbetocin group but not statistically significant (p=0.8).Conclusion. In planned CS, a possible clinical significant lower incidence of nausea after carbetocin was noted but this was not statistically significant. There were no differences regarding BP, heart rate, the need for vasopressor, and blood loss. The study was registered in the International Journal of Clinical Trials (ISRCTN95504420, 2/2017).

scholarly journals A randomized controlled trial comparing oxytocin administration before and after placental delivery in the prevention of postpartum haemorrhage in a tertiary care hospital in Bankura district of West Bengal, India

2020 ◽  
Vol 9 (5) ◽  
pp. 1976
Author(s):  
Rahul Kirtania ◽  
Jayita Pal ◽  
Sisir Biswas ◽  
Aditi Aich
Keyword(s):  
Randomized Controlled Trial ◽  
Blood Loss ◽  
Controlled Trial ◽  
Active Management ◽  
Control Group ◽  
Care Hospital ◽  
Normal Delivery ◽  
Randomized Controlled ◽  
Significant Difference ◽  
The Mean

Background: PPH is the prime cause of maternal mortality worldwide. The incidence of PPH can be drastically combatted by application of uterotonic in active management of third stage labour. Timing of its administration is a matter of concern. This study aimed to assess whether timing of administration of oxytocin would have any impact on incidence or mean blood loss of PPH.Methods: It was a single blinded randomized controlled trial conducted in the department of Obstetrics and Gynecology, Bankura Sammilani Medical College for 6 months where 100 antenatal mothers admitted for normal delivery in labour room were allocated randomly in study and control group considering inclusion and exclusion criteria. Incidence of PPH and mean blood loss had been identified clinically by following them for 24 hours.Results: Only 9% of study population had experienced PPH. There was no statistically significant difference in incidence of PPH with difference in timing of administration of oxytocin (p >0.05). But there was statistically significant decrease in mean blood loss if oxytocin was administered before the placental delivery. The mean blood loss with oxytocin administered before placental delivery was 296.8 ml (102.45) and after placental delivery was 452.0 (128.87) ml respectively.Conclusions: Policy makers should keep in mind not only the incidence of PPH, but the mean blood loss amount too in a setting where anaemia in pregnancy is quite prevalent.

Effects of Guitar Accompaniment Patterns on Hospitalized Infants: A Randomized Controlled Trial

2021 ◽  
Author(s):  
Kory Antonacci ◽  
Nicole Steele ◽  
Jacob Wheatley ◽  
Donna M Weyant ◽  
Beverly Brozanski ◽  
...  
Keyword(s):  
Heart Rate ◽  
Randomized Controlled Trial ◽  
Music Therapy ◽  
Neonatal Intensive Care ◽  
Controlled Trial ◽  
Pain Scale ◽  
Post Intervention ◽  
Randomized Controlled ◽  
Stressful Environment ◽  
The Difference

Abstract A neonatal intensive care unit (NICU) can be an extremely stressful environment for infants receiving complex medical care at a pediatric facility. Music therapy can help address the stressful environment by increasing comfort and relaxation as well as decreasing a patient’s physiological response of heart rate and respiratory rate. A randomized controlled trial was completed, examining the effects of 2 guitar accompaniment patterns on infants (an arpeggiated pattern and a bass/chord pattern) in a NICU. There were 180 infants enrolled with mean chronological ages of 7.4 ± 6.1 weeks and postmenstrual ages (gestational age at birth + their chronological age) of 39.8 ± 7.9 weeks. All subject enrollees participated in a 12-minute initial music therapy session. Outcome measures included heart rate, respirations, and comfort responses. The results of the research study demonstrated that the arpeggiated guitar pattern had a lower mean heart rate and respiratory across all 3 data points (pre, during, and post intervention); however, the difference in means between the 2 accompaniment pattern groups was not statistically significant. Using the Neonatal Infant Pain Scale (NIPS) to measure comfort response, the results demonstrated no difference between the 2 group accompaniment patterns. Although the results show no significant differences among accompaniment pattern groups, the researchers describe the clinical significance that supports the use of both accompaniment patterns as suitable interventions for infants in the NICU receiving music therapy intervention.

scholarly journals A Brief Intervention to Increase Uptake and Adherence of an Internet-Based Program for Depression and Anxiety (Enhancing Engagement With Psychosocial Interventions): Randomized Controlled Trial (Preprint)

2020 ◽  
Author(s):  
Philip J Batterham ◽  
Alison L Calear ◽  
Matthew Sunderland ◽  
Frances Kay-Lambkin ◽  
Louise M Farrer ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Behavioral Therapy ◽  
Controlled Trial ◽  
Psychosocial Interventions ◽  
P Uptake ◽  
Depression And Anxiety ◽  
Randomized Controlled ◽  
Significant Difference ◽  
The Difference ◽  
Clinical Trials Registry

BACKGROUND Psychosocial, self-guided, internet-based programs are effective in treating depression and anxiety. However, the community uptake of these programs is poor. Recent approaches to increasing engagement (defined as both uptake and adherence) in internet-based programs include brief engagement facilitation interventions (EFIs). However, these programs require evaluation to assess their efficacy. OBJECTIVE The aims of this hybrid implementation effectiveness trial are to examine the effects of a brief internet-based EFI presented before an internet-based cognitive behavioral therapy self-help program (<i>myCompass 2</i>) in improving engagement (uptake and adherence) with that program (primary aim), assess the relative efficacy of the <i>myCompass 2</i> program, and determine whether greater engagement was associated with improved efficacy (greater reduction in depression or anxiety symptoms) relative to the control (secondary aim). METHODS A 3-arm randomized controlled trial (N=849; recruited via social media) assessed the independent efficacy of the EFI and <i>myCompass 2</i>. The <i>myCompass 2</i> program was delivered with or without the EFI; both conditions were compared with an attention control condition. The EFI comprised brief (5 minutes), tailored audio-visual content on a series of click-through linear webpages. RESULTS Uptake was high in all groups; 82.8% (703/849) of participants clicked through the intervention following the pretest survey. However, the difference in uptake between the EFI + <i>myCompass 2</i> condition (234/280, 83.6%) and the <i>myCompass 2</i> alone condition (222/285, 77.9%) was not significant (n=565; <i>χ</i><sup>2</sup><sub>1</sub>=29.2; <i>P=</i>.09). In addition, there was no significant difference in the proportion of participants who started any number of modules (1-14 modules) versus those who started none between the EFI + <i>myCompass 2</i> (214/565, 37.9%) and the <i>myCompass 2</i> alone (210/565, 37.2%) conditions (n=565; <i>χ</i><sup>2</sup><sub>1</sub><0.1; <i>P=</i>.87). Finally, there was no significant difference between the EFI + <i>myCompass 2</i> and the <i>myCompass 2</i> alone conditions in the number of modules started (<i>U</i>=39366.50; <i>z</i>=−0.32; <i>P=</i>.75) or completed (<i>U</i>=39494.0; <i>z</i>=−0.29; <i>P=</i>.77). The <i>myCompass 2</i> program was not found to be efficacious over time for symptoms of depression (<i>F</i><sub>4,349.97</sub>=1.16; <i>P=</i>.33) or anxiety (<i>F</i><sub>4,445.99</sub>=0.12; <i>P=</i>.98). However, planned contrasts suggested that <i>myCompass 2</i> may have been effective for participants with elevated generalized anxiety disorder symptoms (<i>F</i><sub>4,332.80</sub>=3.50; <i>P=</i>.01). CONCLUSIONS This brief internet-based EFI did not increase the uptake of or adherence to an existing internet-based program for depression and anxiety. Individuals’ motivation to initiate and complete internet-based self-guided interventions is complex and remains a significant challenge for self-guided interventions. CLINICALTRIAL Australian New Zealand Clinical Trials Registry ACTRN12618001565235; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=375839

A noninferiority cluster-randomized controlled trial on antibiotic postprescription review and authorization by trained general pharmacists and infectious disease clinical fellows

2018 ◽  
Vol 39 (10) ◽  
pp. 1154-1162 ◽  
Author(s):  
Pinyo Rattanaumpawan ◽  
Prasit Upapan ◽  
Visanu Thamlikitkul
Keyword(s):  
Infectious Disease ◽  
Randomized Controlled Trial ◽  
Clinical Response ◽  
Controlled Trial ◽  
Cluster Randomized Controlled Trial ◽  
Randomized Controlled ◽  
Significant Difference ◽  
Favorable Clinical Response ◽  
The Difference ◽  
Cluster Randomized

AbstractObjectiveWe compared the effectiveness of antibiotic postprescription review and authorization (PPRA) determined by infectious disease (ID) clinical fellows with that of trained general pharmacists.MethodsWe conducted a noninferiority cluster-randomized controlled trial in 6 general medical wards at Siriraj Hospital in Bangkok, Thailand. Three wards were randomly assigned to the intervention (ie, the pharmacist PPRA group), and another 3 wards were assigned to the control (ie, the fellow PPRA group). We enrolled all patients in the study wards who received 1 or more doses of the targeted antibiotics: piperacillin/tazobactam, imipenem/cilastatin, and meropenem. The noninferiority margin was 10% for the favorable clinical response and 1.5 defined daily doses (DDDs) for the targeted antibiotics.ResultsWe enrolled 303 patients in the pharmacist PPRA group and 307 patients in the ID fellow PPRA group. The baseline and clinical characteristics were similar in the 2 groups. The difference in the favorable response of patients who received the targeted antibiotics (ie, the pharmacist PPRA group minus the fellow PPRA group) was 5.15% (95% confidence interval [CI], –2.69% to 12.98%); the difference in the DDD of targeted antibiotic use (ie, the pharmacist PPRA group minus the fellow PPRA group) was 0.62 (95% CI, –1.57 to 2.82). We observed no significant difference in the DDD of overall antibiotics, 28-day mortality, 28-day ID-related mortality, favorable microbiological outcome, or antibiotic-associated complications.ConclusionsWe confirmed the noninferiority of pharmacist PPRA in terms of favorable clinical response; however, noninferiority in targeted antibiotic consumption could not be established. Therefore, using trained general pharmacists rather than ID clinical fellows could be an alternative in a resource-limited setting.Clinical trials registration: clinicaltrials.gov identifier: NCT 01797133

scholarly journals Spontaneous delivery or manual delivery of the placenta during caesarean: A randomized controlled trial

2012 ◽  
Vol 7 (2) ◽  
pp. 23-28 ◽  
Author(s):  
SM Pokharel
Keyword(s):  
Randomized Controlled Trial ◽  
Caesarean Section ◽  
Blood Loss ◽  
Controlled Trial ◽  
Medical Sciences ◽  
Manual Removal ◽  
Randomized Controlled ◽  
The Mean ◽  
Spontaneous Delivery

The study was done to compare the blood loss and the time between spontaneous delivery and manual removal of the placenta during caesarean section. We prospectively randomized and compared outcomes of 100 gravid women with manual (n=50) and spontaneous (n=50) placental delivery at caesarean section. Blood loss was measured after placental deliverey at caesarean and was greater in the manually delivered group (100.9 ± 22.5 ml) than in the spontaneous delivery group. (55.11 ±21.07 ml) P< 0.001. The mean interval during the delivery of the newborn and the placenta is longer in spontaneous delivery group (62.02 vs. 50.5 seconds), but the mean duration of the operation was similar. Spontaneous delivery of the placenta as compared to manual expression significantly reduces the blood loss without increasing the operating time.Journal of College of Medical Sciences-Nepal, 2011, Vol-7, No-2, 23-28DOI: http://dx.doi.org/10.3126/jcmsn.v7i2.6676

The Effect of a Spiritual Care on Hope in Patients Undergoing Hemodialysis: A Randomized Controlled Trial

2020 ◽  
Vol 16 (1) ◽  
pp. 68-75
Author(s):  
Khodayar Oshvandi ◽  
Shilla Amini ◽  
Abbas Moghimbeigi ◽  
Efat Sadeghian
Keyword(s):  
Randomized Controlled Trial ◽  
Spiritual Care ◽  
Controlled Trial ◽  
Care Program ◽  
Psychological Problem ◽  
Hemodialysis Patients ◽  
Randomized Controlled ◽  
Significant Difference ◽  
The Difference ◽  
And Control

Background: The most common psychological problem in hemodialysis patients is low hope. Hope is an important source of adaptation for the survival of the patients with a chronic disease. Objective: This study aimed to evaluate the effect of spiritual care on hope in patients undergoing hemodialysis. Methods: In this randomized controlled trial conducted in Iran in 2017, 60 hemodialysis patients with ending-stage of renal disease under hemodialysis treatment were randomly assigned into two experimental (n=30) and control (n=30) groups. The spiritual care program consisting of protectionist care, supporting the patient's rituals and using support systems was administered in four sessions of 60 minutes individually, twice a week, morning or evening in hemodialysis ward. Snyder’s Hope Questionnaire was completed before and after the intervention in both groups. Data were analyzed in SPSS software version 16. Results: Prior to the intervention, there was no significant difference between the experimental and control groups (p=0.262); however, following the intervention, the difference was statistically significant with regard to the mean scores of hope in the experimental (36.43 ± 3.37) and control (35.20 ± 7.00) groups (p=0.04). Conclusion: According to the findings of the present study, spiritual care promotes hope in Muslim patients undergoing hemodialysis; therefore, nurses can adopt the spiritual care to this end.

scholarly journals Randomized controlled trial of three oxytocic regimens to prevent primary postpartum haemorrhage at caesarean section

Mediscope ◽  
2017 ◽  
Vol 4 (2) ◽  
pp. 5-11
Author(s):  
AJ Peea ◽  
F Begum ◽  
E Saha
Keyword(s):  
Randomized Controlled Trial ◽  
Side Effects ◽  
Caesarean Section ◽  
Blood Loss ◽  
Postpartum Haemorrhage ◽  
Controlled Trial ◽  
Randomized Controlled ◽  
Group 3 ◽  
Group 2 ◽  
Group 1

The objective of this present study was to compare the efficacy of three oxytocic regimens to prevent primary postpartum haemorrhage (PPH) at caesarean section. A randomized controlled trial including 90 patients who underwent caesarean section were selected according to inclusion and exclusion criteria assigned randomly into three groups (30 patients in each group) was conducted. Group 1 and group 2 were exposure groups and group 3 was control group. All patients were given 10 units intravenous (IV) bolus oxytocin immediately after delivery of baby. Group 1 was given additional 20 units oxytocin in each 1000 ml fluid for 24 hours. Group 2 received additional 1000 microgram misoprostol per rectal. Group 3 did not receive any additional oxytocic drug. Background characteristics of all the three groups were similar. It was observed that 501-1000 ml blood loss was found among 25 (83.3%) cases in group 1, 27 (90.0%) in group 2 and 27 (90.0%) in group 3. The mean (SD) amount of blood loss was found 733 (190) ml in group 1792 (187) ml in group 2 and 818 (14) ml in group 3. Occurrence of PPH and blood transfusion needed among 1 (3.3%) in group 1, 2 (6.7%) in group 2 and 3 (10.0%) in group 3. Side effects occurred in 7 (23.3%) patients of group 1, 18 (60.0%) in group 2, and 6 (20.0%) in group 3. Shivering was found among 4 (13.3%) in group 1, 10 (33.3%) in group 2 and 3 (10%) in group 3. Vomiting was found among 2 (6.7%) in group 1, 4 (13.3%) in group 2, and 2 (6.7%) in group 3. Pyrexia was 1 (3.3%) in group 1, 4 (13.3%) in group 2 and 1 (3.3%) in group 3. Side effects were more in the group where misoprostol was used. Except side effects there was no statistical difference of occurrence of different events among the three groups. Only bolus IV oxytocin appears to be as effective as oxytocin infusion in addition to bolus IV oxytocin or per rectal misoprostol in addition to bolus IV oxytocin to prevent primary PPH at caesarean section. But occurrence of transient side effects such as shivering, pyrexia and vomiting were noted more frequently with the use of misoprostol.Mediscope Vol. 4, No. 2: Jul 2017, Page 5-11

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