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Cooling the lower abdomen to reduce postpartum blood loss: A randomized controlled trial.

ABSTRACT: Cooling the lower abdomen is one of the Japanese traditional non-pharmacological prophylactic managements for postpartum hemorrhage. This study aimed to evaluate the effectiveness of cooling the lower abdomen in reducing postpartum blood loss compared with no intervention. In both cases, women delivered vaginally without prophylactic oxytocin in the third stage of labor.In this randomized controlled trial, the lower abdomen was cooled by placement of an 8.6°C icepack during the first 2 h after placental delivery. The primary outcome was measured as the total blood loss within 2 h after delivery. This study had 80% power at the two tails of 5% significance level to detect the mean difference (MD, 70 g) in total blood loss within 2 h after delivery between the two groups. The sample size was calculated as 144 women (72 women per group).Between January and May 2016, 160 women were randomly assigned to the intervention group (cooling the lower abdomen, n = 81) or the control group (n = 79). Baseline characteristics were similar between groups, with the exception of mean blood loss during the third stage of labor. The primary outcome was not reduced by cooling, compared with no intervention (mean blood loss, 513.3 vs. 478.1 g, respectively; MD = 35.2 g; 95% confidence interval = -65.3-135.7). No adverse events occurred; however, seven (8.7%) women in the intervention group declined to continue cooling the lower abdomen because of discomfort.Compared with the control group, cooling the lower abdomen did not reduce the total amount of blood loss up to 2 h after delivery.UMIN-CTR UMIN000019834.

SUBMITTER: Masuzawa Y

PROVIDER: S-EPMC5642889 | biostudies-literature | 2017

REPOSITORIES: biostudies-literature

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Cooling the lower abdomen to reduce postpartum blood loss: A randomized controlled trial.

Masuzawa Yuko Y Kataoka Yaeko Y Nakamura Saki S Yaju Yukari Y

PloS one 20171016 10

<h4>Background</h4>Cooling the lower abdomen is one of the Japanese traditional non-pharmacological prophylactic managements for postpartum hemorrhage. This study aimed to evaluate the effectiveness of cooling the lower abdomen in reducing postpartum blood loss compared with no intervention. In both cases, women delivered vaginally without prophylactic oxytocin in the third stage of labor.<h4>Methods</h4>In this randomized controlled trial, the lower abdomen was cooled by placement of an 8.6°C i ...[more]

PMID: 29036203

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Project description:PurposeThe purpose of this study was to test our MUSTCOOL cooling patch intervention on the incidence of venous leg (VLU) and diabetic foot ulcer (DFU) recurrence over a previously healed wound.DesignA 6-month randomized controlled trial.Subjects and settingThe target population was individuals with previously healed ulcers receiving care in outpatient wound centers in the Southeastern region of the United States. The sample comprised 140 individuals with recently healed ulcers; their average age was 62.4 years (SD = 12 years); 86 (61.4%) were male; and 47 (33.6%) were Black or African American.MethodsParticipants were randomized to the MUSTCOOL or placebo patch. Both groups received instructions to apply the patch 3 times per week, and engage in standard of care including compression and leg elevation (VLU) or therapeutic footwear and hygiene (DFU). Demographic data were collected at baseline, and incidence measures taken at 1, 3, and 6 months. We also studied whether new ulcers developed on the adjacent leg or foot. Data were reported in frequencies/percentages.ResultsOne hundred seventeen participants (84%) were analyzed who completed 6 months of study participation. Thirteen percent (9/69) and 17% (12/69) developed a recurrent or new VLU, respectively; 29% (14/48) and 13% (6/48) developed a recurrent or new DFU, respectively. One person in the DFU group developed both a recurrent and new ulcer. For 9 recurrent VLUs, 6 (66.7%) recurred in the MUSTCOOL group and 3 (33.3%) receiving the placebo. Of the 15 recurrent DFUs (includes individual who developed both a recurrent and new ulcer), 10 (66.7%) recurred in the MUSTCOOL group and 5 (33.3%) receiving the placebo.ConclusionsWhile the incidence of ulcer recurrent was slightly higher in the MUSTCOOL group, this finding was not considered clinically relevant. Overall ulcer recurrence during the 6-month study period was lower than reports in the literature, the time frame in which recurrence rates are highest.Trial registrationThe study was prospectively registered with ClinicalTrials.gov on December 10, 2015 (Identifier: NCT02626156)-https://clinicaltrials.gov/ct2/show/NCT02626156.

Project description:OBJECTIVE:To analyze the effects of cryolipolysis on the fat thickness of the lower abdomen of healthy women and patient's satisfaction. METHODS:Design and setting: a randomized controlled trial, with concealed allocation and blinded assessor. PARTICIPANTS:34 healthy women between 18 and 48 years, skinfold in the lower abdomen ?3cm, BMI between 18.5 and 27kg/m2, low level of physical activity, and no contraindication to cryolipolysis were allocated to intervention group (IG, n=17) or control group (CG, n=17). INTERVENTIONS:The IG received one session of cryolipolysis with -10°C of temperature for 50min. The CG was not submitted to any kind of intervention. Both groups did the evaluation protocols at baseline, 30, 60 and 90 days after the intervention. MAIN OUTCOME MEASURES:fat thickness was measured by ultrasonography (US), skinfold (SF) and abdominal circumference (AC1 and AC2). RESULTS:No significant differences between the IG and CG were demonstrated at any evaluation at any time of follow up for the variables US (30 days: 0.05cm (95%CI: -0.12; 0.22), 60 days: 0.05cm (95%CI: -0.11; 0.20) and 90 days: 0.04cm (95%CI: -0.7; 0.25)), SF (30 days: -0.09cm (95%CI: -0.25; 0.08), 60 days: -0.14cm (95%CI: -0.36; 0.09) and 90 days: -0.001cm (95%CI: -0.237; 0.234)), AC1 (30 days: 0.42cm (95%CI: -1.1; 1.9), 60 days: -0.1cm (95%CI: -1.74; 1.54) and 90 days: -0.007cm (-1.9; 1.9)) and AC2 (30 days: 0.183cm (95%CI: -0.84; 1.20), 60 days: -0.13cm (95%CI: -1.61; 1.35) and 90 days: -0.31cm (95%CI: -1.61; 1.00)). CONCLUSIONS:The current study showed that a single application of the utilized protocol of cryolipolysis does not produce any significant effect on fat thickness of the lower abdomen of healthy women. CLINICAL TRIAL REGISTRATION NUMBER:NCT03160976 (https://clinicaltrials.gov/ct2/show/NCT03160976). Contribution of the Paper: the study is one of the first studies in the literature with methodological rigor to report an unfavorable result for localized abdominal fat treatment with a single session of cryolipolysis.

Project description:BackgroundPrevious studies have suggested that psychological interventions may be effective in reducing blood pressure. Using rigorous methodology and 24-hour monitoring of ambulatory blood pressure, we compared 2 psychological interventions with treatment using a first-line antihypertensive drug in terms of their efficacy in lowering blood pressure in patients with mild primary hypertension.MethodsIn this prospective, open-label randomized controlled trial (RCT), 65 adult patients with mild, uncomplicated hypertension were randomly assigned to receive one of the following interventions for 12 weeks: (1) pharmacotherapy with hydrochlorothiazide 12.5 titrated to 25 mg/d ; (2) individualized behavioural psychotherapy, consisting of ten 1-hour sessions of stress reduction training with a psychologist; or (3) self-help psychotherapy, consisting of a 1.5-hour session with a psychologist and then daily sessions that involved reading a self-help manual and listening to an audiotape. The primary outcome measure was mean change in ambulatory blood pressure from baseline to week 12. Resting blood pressure readings were taken in the clinic, and adverse events were recorded.ResultsMonitoring of ambulatory blood pressure over 24 hours showed that hydrochlorothiazide therapy significantly reduced both systolic and diastolic blood pressure relative to baseline, and that this reduction was significantly greater than that achieved with either individualized behavioural psychotherapy or self-help psychotherapy (mean reduction [standard error; SE] -11.03 [2.53] / -6.06 [1.56] mm Hg v. -0.08 [2.38] / 0.29 [1.47] mm Hg v. -1.23 [2.83] / -0.71 [1.75] mm Hg, respectively; p = 0.01). Neither form of psychological therapy significantly lowered 24-hour ambulatory blood pressure relative to baseline.ConclusionFor patients with primary elevated blood pressure, 2 psychological interventions did not lower 24-hour ambulatory blood pressure, whereas hydrochlorothiazide reduced blood pressure, as expected. The findings of this RCT represent an important addition to the evidence for health care practitioners and for patients seeking psychological interventions to reduce blood pressure.

Project description:BackgroundTotal knee arthroplasty (TKA) is associated with a significant blood loss. Several methods have been reported to reduce postoperative blood loss and avoid homologous blood transfusions. In this study, we investigated the efficacy of temporary clamping of the drain either or not in combination with tranexamic acid administration for controlling blood loss after TKA.MethodsThe prospective, randomized, and double-blinded study was conducted in our institute. Total of 240 patients, who diagnosed primary osteoarthritis and scheduled to undergo a primary TKA,,were randomized into one of the four groups: Group A or control group, the drain was not clamped and the patient received a placebo; Group B, the drain was not clamped and the patient received tranexamic acid; Group C, the drain was clamped and the patient received a placebo; and Group D, the drain was clamped and the patient received tranexamic acid. The volume of drained blood at 48 hours postoperatively, the decreasing of hemoglobin (Hb) level at 12 hours postoperatively and the number of patients requiring blood transfusion were recorded and compared.ResultsThe mean postoperative volumes of drained blood and the amount of blood transfusion in the three study groups (group B, C and D) were significantly lower than those in the control group (p < 0.05), which group D had the lowest values. Furthermore, group B and D could maintain the Hb level better than group A and C (p < 0.001). In terms of blood transfusions rate, although the patients in group D required transfusion less than group A and C (p < 0.05), there was no significant difference between group D and B. The relative risks for transfusion requirement were 4.4 for group A, 1.4 for group B and 3.0 for group C when compared to group D.ConclusionsThe clamping of drain combined with tranexamic acid administration could reduce postoperative blood loss and blood transfusion after TKA, significantly greater than using tranexamic acid or drain clamping alone.Trial registrationClinicalTrials.gov NCT01449552.

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Cooling the lower abdomen to reduce postpartum blood loss: A randomized controlled trial.

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Cooling the lower abdomen to reduce postpartum blood loss: A randomized controlled trial.

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