Low-intensity ultrasound promotes uterine involution after cesarean section: the first multicenter, randomized, controlled clinical trial

Abstract Background Depressive symptoms are quite prevalent in Primary Care (PC) settings. The treatment as usual (TAU) in PC is pharmacotherapy, despite the high relapse rates it produces. Many patients would prefer psychotherapy, but specialized services are overloaded. Studies that apply Mindfulness-Based Interventions (MBIs) for the treatment of depression have obtained significant improvements. Brief low-intensity approaches delivered from PC could be a promising approach. This study aims to compare a low-intensity mindfulness intervention for the treatment of depression in PC using different intervention formats – a face-to-face MBI delivered in a group and the same MBI individually applied on the Internet – to a control group that will receive PC medical treatment as usual. Methods A randomized controlled clinical trial will be conducted in PC, with about 120 depressed patients allocated (1:1:1) to three groups: “face-to-face MBI + TAU”, “Internet-delivered MBI + TAU”, and “TAU alone”. The MBI programs will be composed of four modules. The primary outcome will be depressive symptoms, measured through the Beck Depression Inventory, assessed at pre- and post-treatment and 6- and 12-month follow-ups. Other outcomes will be mindfulness, happiness, affectivity, quality of life, and the use of healthcare services. Intention-to-treat analysis using linear mixed models adjusted for baseline scores and routine sociodemographic analysis that could show baseline differences will be conducted. Per-protocol secondary outcome analyses will also be performed. Discussion This is the first Spanish RCT to apply a low-intensity face-to-face MBI (plus TAU) to treat depression in PC settings compared to TAU (alone). Moreover, this study will also make it possible to evaluate the same MBI program (plus TAU), but Internet-delivered, considering their cost-effectiveness. Positive results from this RCT might have an important impact on mental health settings, helping to decrease the overload of the system and offering treatment alternatives beyond antidepressant medication through high-quality, flexible PC interventions. Trial registration Clinical Trials.gov NCT03034343. Trial Registration date 24 January 2017, retrospectively registered.

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The Effect of Intravenous Tranexamic Acid on Hemoglobin and Hematocrit Levels After Cesarean Delivery: a Randomized Controlled Clinical Trial

10.21203/rs.3.rs-838710/v1 ◽

2021 ◽

Author(s):

Esmat Jafarbegloo ◽

Faride Faridnyia ◽

Atefeh sadat mohammad hoseini nejad

Keyword(s):

Clinical Trial ◽

Cesarean Section ◽

Tranexamic Acid ◽

Control Group ◽

Controlled Clinical Trial ◽

Hematocrit Level ◽

Randomized Controlled Clinical Trial ◽

Randomized Controlled ◽

Novel Approach ◽

Significant Difference

Abstract Background: During a cesarean section, the mother loses a lot of blood. This bleeding can cause a drop in hemoglobin and hematocrit. Tranexamic acid, an anti-fibrinolytic agent, is a novel approach in an attempt to prevent this dreadful complication. This study aims to explore the effect of intravenous tranexamic acid on hemoglobin and hematocrit level after cesarean section(CS) in women who were low risk in postpartum hemorrhage.Methods: This prospective randomised placebo-controlled clinical trial was carried out on 50 pregnant women referred to Izadi hospital, Qom, Iran, 2017. women were divided into two groups of 25 cases using block randomization. The study group, 25 women, received tranexamic acid 10 minutes before CS whereas the control group, 25 women received distilled water. Hemoglobin and hematocrit levels were measured before and 12-24 hours after delivery. Results: There was no significant difference in pre-operative and 12-24 h post-operative hemoglobin and hematocrit levels between the two groups(p>0.05). Conclusions: Pre-operative prescription of 1gr tranexamic acid was not associated with improvement of post-operative hemoglobin and hematocrit.Trial registration: IRCT20091010002558N7.

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