Heat stable carbetocin vs. oxytocin for the prevention of post-partum hemorrhage in emergency caesarean delivery: a randomized controlled trial

2021 ◽  
Vol 0 (0) ◽  
Author(s):  
Shaymaa Al Zubaidi ◽  
Taghreed Alhaidari
Keyword(s):  
Blood Pressure ◽  
Blood Transfusion ◽  
Pulse Rate ◽  
Post Partum ◽  
Controlled Trial ◽  
Relative Risks ◽  
Heat Stable ◽  
Emergency Cesarean ◽  
Clinically Significant ◽  
Double Blinded

Abstract Objectives To evaluate the uterotonic effect of carbetocin compared with oxytocin in emergency cesarean delivery in Iraq. Methods A double-blinded randomized noninferiority single center trial. Three-hundred patients were systematically randomized to intravenous bolus injection of 10 IU oxytocin or 100 mcg carbetocin after delivery in a ratio of 2:1. The primary outcome was additional uterotonic use when inadequate uterine tone occur in the first 24 h after delivery. Secondary outcomes include the need for blood transfusion, blood pressure and pulse rate changes within an hour of drugs administration. Noninferiority margins for the relative risks outcomes was 4%. Results Addition uterotonics use was significantly lower in carbetocin group with a risk ratio of 0.36. Carbetocin was superior to oxytocin in reducing the need for additional uterotonic drugs by 12% and non-inferior to oxytocin for blood transfusion 3.5%. Noninferiority was not shown for the outcome of sever blood loss. Miner changes in blood pressure and pulse rate were observed in carbetocin group compared to oxytocin but clinically were not significant. Conclusions Heat stable carbetocin is effective in reducing additional uterotonics use compared to oxytocin without clinically significant change in blood pressure or pulse rate, therefore, can be a potential alternative in Iraq.

A randomized controlled trial to measure the effects of specific thoracic chiropractic adjustments on blood pressure and pulse rate

2011 ◽  
Vol 14 (4) ◽  
pp. 169-170
Author(s):  
Steven Roffers ◽  
Laura Huber ◽  
David Morris ◽  
Anquonette Stiles ◽  
Derek Barton ◽  
...  
Keyword(s):  
Blood Pressure ◽  
Randomized Controlled Trial ◽  
Pulse Rate ◽  
Controlled Trial ◽  
Randomized Controlled

scholarly journals Microbial Interventions to Control And Reduce Blood Pressure In Australia (Microbia): Rationale And Design of A Double-Blinded Randomised Cross-Over Placebo Controlled Trial

2021 ◽  
Author(s):  
Dakota Rhys-Jones ◽  
Rachel Climie ◽  
Hamdi Jama ◽  
Paul Gill ◽  
Geoffrey Head ◽  
...  
Keyword(s):  
Blood Pressure ◽  
Clinical Trial ◽  
Gut Microbiota ◽  
Resistant Starch ◽  
Corn Starch ◽  
Controlled Trial ◽  
Short Chain Fatty Acids ◽  
Reduce Blood Pressure ◽  
Clinical Trial Registry ◽  
Double Blinded

Abstract Background: Hypertension is a prevalent chronic disease worldwide that remains poorly controlled. Recent studies support the concept that the gut microbiota is involved in the development of hypertension, and that dietary fibre intake may act through the gut microbiota to lower blood pressure (BP). Resistant starch is a type of prebiotic fibre which is metabolized by commensal bacteria in the colon to produce short-chain fatty acids (SCFA), including acetate, propionate, and butyrate. Previous work in pre-clinical models provide strong evidence that both prebiotic fibre as well as SCFAs (i.e. postbiotics) can prevent the development of hypertension. The aim of this clinical trial is to determine if acetylated and butyrylated modified resistant starch can decrease BP of hypertensive individuals via the modulation of the gut microbiota and release of high levels of SCFAs. Methods: This is a phase IIa double-blinded, randomised, cross-over, placebo controlled trial. Participants are randomly allocated to receive either a diet containing 40g/day of the modified resistant starch or placebo (corn starch or regular flour) for three weeks on each diet, with a three week washout period between the two diets. BP is measured in the office, at home, and using a 24 hour ambulatory device. Arterial stiffness is measured using carotid-to-femoral pulse wave velocity. Our primary endpoint is a reduction in ambulatory daytime systolic BP. Secondary endpoints include changes to circulating cytokines, immune markers, and modulation to the gut microbiome. Discussion: The findings of this study will provide the first evidence for the use of a combination of pre- and postbiotics to lower BP in humans. The results are expected at the end of 2021.Trial registration: Australia and New Zealand Clinical Trial Registry ACTRN12619000916145, registered on 1/07/2019.

Measuring the effects of specific cervical chiropractic adjustments on blood pressure and pulse rate: A randomized controlled trial

2011 ◽  
Vol 14 (4) ◽  
pp. 170
Author(s):  
Steven Roffers ◽  
Anquonette Stiles ◽  
Laura Huber ◽  
David Morris ◽  
Derek Barton ◽  
...  
Keyword(s):  
Blood Pressure ◽  
Randomized Controlled Trial ◽  
Pulse Rate ◽  
Controlled Trial ◽  
Randomized Controlled

scholarly journals Effects of grape seed extract beverage on blood pressure and metabolic indices in individuals with pre-hypertension: a randomised, double-blinded, two-arm, parallel, placebo-controlled trial

2015 ◽  
Vol 115 (2) ◽  
pp. 226-238 ◽  
Author(s):  
Eunyoung Park ◽  
Indika Edirisinghe ◽  
Ying Yng Choy ◽  
Andrew Waterhouse ◽  
Britt Burton-Freeman
Keyword(s):  
Blood Pressure ◽  
Plasma Lipids ◽  
Controlled Trial ◽  
Grape Seed Extract ◽  
Grape Seed ◽  
Seed Extract ◽  
Functional Ingredient ◽  
Vascular Adhesion ◽  
Double Blinded ◽  
Metabolic Indices

AbstractThe aim of the present study was to test grape seed extract (GSE) as a functional ingredient to lower blood pressure (BP) in individuals with pre-hypertension. A single-centre, randomised, two-arm, double-blinded, placebo-controlled, 12-week, parallel study was conducted in middle-aged adults with pre-hypertension. A total of thirty-six subjects were randomised (1:1) to Placebo (n 18) or GSE (n 18) groups; twenty-nine of them completed all the protocol-specified procedures (Placebo, n 17; GSE, n 12). Subjects consumed a juice (167 kJ (40 kcal)) containing 0 mg (Placebo) or 300 mg/d GSE (150 mg) twice daily for 6 weeks preceded by a 2-week Placebo run-in and followed by 4-week no-beverage follow-up. Compliance was monitored. BP was measured at screening, 0, 6 and 10 weeks of intervention and blood samples were collected at 0, 3, 6 and 10 weeks of intervention. GSE significantly reduced systolic BP (SBP) by 5·6 % (P=0·012) and diastolic BP (DBP) by 4·7 % (P=0·049) after 6 weeks of intervention period, which was significantly different (SBP; P=0·03) or tended to be different (DBP; P=0·08) from Placebo. BP returned to baseline after the 4-week discontinuation period of GSE beverage. Subjects with higher initial BP experienced greater BP reduction; nearly double the effect size. Fasting insulin and insulin sensitivity tended to improve after 6 weeks of GSE beverage supplementation (P=0·09 and 0·07, respectively); no significant changes were observed with fasting plasma lipids, glucose, oxidised LDL, flow-mediated dilation or vascular adhesion molecules. Total plasma phenolic acid concentrations were 1·6 times higher after 6 weeks of GSE v. Placebo. GSE was found to be safe and to improve BP in people with pre-hypertension, supporting the use of GSE as a functional ingredient in a low-energy beverage for BP control.

scholarly journals Microbial Interventions to Control and Reduce Blood Pressure in Australia (MICRoBIA): rationale and design of a double-blinded randomised cross-over placebo controlled trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Dakota Rhys-Jones ◽  
Rachel E. Climie ◽  
Paul A. Gill ◽  
Hamdi A. Jama ◽  
Geoffrey A. Head ◽  
...  
Keyword(s):  
Blood Pressure ◽  
Clinical Trial ◽  
Gut Microbiota ◽  
Resistant Starch ◽  
Corn Starch ◽  
Controlled Trial ◽  
Short Chain Fatty Acids ◽  
Trial Registration ◽  
Clinical Trial Registry ◽  
Double Blinded

Abstract Background Hypertension is a prevalent chronic disease worldwide that remains poorly controlled. Recent studies support the concept that the gut microbiota is involved in the development of hypertension and that dietary fibre intake may act through the gut microbiota to lower blood pressure (BP). Resistant starch is a type of prebiotic fibre which is metabolised by commensal bacteria in the colon to produce short-chain fatty acids (SCFAs), including acetate, propionate, and butyrate. Previous work in pre-clinical models provides strong evidence that both prebiotic fibre as well as SCFAs (i.e. postbiotics) can prevent the development of hypertension. The aim of this clinical trial is to determine if acetylated and butyrylated modified resistant starch can decrease BP of hypertensive individuals via the modulation of the gut microbiota and release of high levels of SCFAs. Methods This is a phase IIa double-blinded, randomised, cross-over, placebo controlled trial. Participants are randomly allocated to receive either a diet containing 40 g/day of the modified resistant starch or placebo (corn starch or regular flour) for 3 weeks on each diet, with a 3-week washout period between the two diets. BP is measured in the office, at home, and using a 24-h ambulatory device. Arterial stiffness is measured using carotid-to-femoral pulse wave velocity. Our primary endpoint is a reduction in ambulatory daytime systolic BP. Secondary endpoints include changes to circulating cytokines, immune markers, and modulation to the gut microbiome. Discussion The findings of this study will provide the first evidence for the use of a combination of pre- and postbiotics to lower BP in humans. The results are expected at the end of 2021. Trial registration Australia and New Zealand Clinical Trial Registry ACTRN12619000916145. Registered on 1 July 2019.

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