26: Comparing anti-Xa levels in women with body mass index ≥35 post cesarean delivery undergoing enoxaparin thromboprophylaxis with weight-based dosing twice daily versus fixed dose 40 mg daily: a randomized, controlled trial

Abstract Background Obesity and type 2 diabetes mellitus (T2DM) are reaching epidemic proportions. In morbidly obese patients, bariatric operations lead to sustained weight loss and relief of comorbidities in the majority of patients. Laparoscopic Roux-Y-gastric bypass (RYGB) is one of the most frequently performed operations, but it is still unknown why some patients respond better than others. Therefore, a number of variations of this operation have been introduced. Recent evidence suggests that a longer bypassed biliopancreatic limb (BPL) has the potential to be more effective compared to the standard RYGB with a shorter BPL length. This article describes the design and protocol of a randomized controlled trial comparing the outcome of a RYGB operation with a long versus short BPL.Methods/Design The trial is designed as a multicenter, randomized, patient and observer blinded trial. The relevant ethics committee has approved the trial protocol. To demonstrate that long BPL RYGB is superior compared to short BPL RYGB in terms of weight loss and resolution of T2DM the study is conducted as a superiority trial. Postoperative percent excess body mass index loss (%EBMIL) is the primary endpoint, whereas morbidity, mortality, remission of obesity related comorbidities and quality of life are secondary endpoints. Eight hundred patients, between 18 and 65 years and with a body mass index (BMI) from 35 to 60 kg/m2 who meet the regulatory rules for bariatric surgery in Switzerland will be randomized. The endpoints and baseline measurements will be assessed pre-, intra- and postoperatively.Discussion With its high number of patients and a 5-year follow-up this study will answer questions about effectiveness and safety of long BPL RYGB and provide level I evidence for improvement of the standard RYGB. These findings might therefore potentially influence global bariatric surgery guidelines.Trial registration This trial was registered on ClinicalTrials.gov under the identifier NCT04219787, on January 7th, 2020.

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Preconception Micronutrient Supplementation Affects Maternal Body Mass Index Post-Partum: A Randomized Controlled Trial in Vietnam

Current Developments in Nutrition ◽

10.1093/cdn/nzaa053_097 ◽

2020 ◽

Vol 4 (Supplement_2) ◽

pp. 892-892

Author(s):

Usha Ramakrishnan ◽

Melissa Young ◽

Long Khuong ◽

Lan Mai Tran ◽

Thai Hong Duong ◽

...

Keyword(s):

Body Mass Index ◽

Randomized Controlled Trial ◽

Body Mass ◽

Post Partum ◽

Controlled Trial ◽

Intervention Group ◽

Anthropometric Measurements ◽

Maternal Body Mass Index ◽

Randomized Controlled ◽

The Impact

Abstract Objectives While there is growing evidence on the role of preconception nutrition for birth outcomes, very few studies have evaluated the effects of nutrition interventions during the preconception period on maternal health. This study evaluates the impact of preconception weekly multiple micronutrients (MM) or iron and folic acid (IFA) supplementation compared to FA alone on maternal nutritional status through 6–7y post-partum (PP). Methods We followed women who participated in a randomized controlled trial of preconception supplementation in Vietnam and delivered live offspring (n = 1599). Women received weekly supplements containing either 2800 μg FA only, 60 mg iron and 2800 μg FA, or MM (15 micronutrients including IFA), from baseline until conception; followed by daily prenatal IFA supplements until delivery. Anthropometric measurements were obtained at recruitment and at 2 and 6–7 y PP. Group comparisons were done using ANOVA or chi-square tests. Results The groups were similar for baseline (preconception) maternal and offspring birth characteristics. Mean (SD) Body Mass Index (BMI; kg/m2) increased from 19.6 (2.1) at baseline, to 20.4 (2.4) and 21.6 (2.8) at 2 and 6–7 y PP (n = 931). The prevalence of overweight (BMI ≥ 23.5 kg/m2) also increased from 4.7% to 9% and 21%, at baseline, 2, and 6–7 years PP respectively, while underweight (BMI < 18.5 kg/m2) declined from 31.4% to 21.4% and 10%, respectively. At 6–7 y PP, we found significant differences (P < 0.01) by intervention group for mean BMI (MM: 22.0 (2.4), IFA: 21.6 (2.7); FA:21.4 (2.9)), and the prevalence of underweight (MM: 5.1%, IFA: 10.1%; FA:14.4%), but no differences in overweight (MM: 21.3%, IFA:20.3%; FA:21.3%), or other anthropometric measurements (weight to hip ratio, arm circumference and skinfold thickness). Conclusions Preconception supplementation with MM resulted in higher BMI and greater reductions in maternal underweight when compared to IFA and FA only. The prevalence of overweight increased dramatically over time but there with no differences by intervention group at 6–7 y PP. These findings suggest that preconception micronutrient interventions may have long term effects on maternal BMI that need to be further examined. Funding Sources The Nestle Foundation, the Mathile Institute, and the Micronutrient Initiative.

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