scholarly journals Study protocol for a randomised controlled trial evaluating the effect of prenatal omega-3 LCPUFA supplementation to reduce the incidence of preterm birth: the ORIP trial

BMJ Open ◽  
2017 ◽  
Vol 7 (9) ◽  
pp. e018360 ◽  
Author(s):  
Shao J Zhou ◽  
Karen Best ◽  
Robert Gibson ◽  
Andrew McPhee ◽  
Lisa Yelland ◽  
...  
Keyword(s):  
Preterm Birth ◽  
Caesarean Section ◽  
Controlled Trial ◽  
Multiple Pregnancy ◽  
Chain Polyunsaturated Fatty Acid ◽  
Control Group ◽  
Omega 3 ◽  
Perinatal Complications ◽  
Primary Analysis ◽  
Secondary Outcomes

IntroductionPreterm birth accounts for more than 85% of all perinatal complications and deaths. Seventy-five per cent of early preterm births (EPTBs) occur spontaneously and without identifiable risk factors. The need for a broadly applicable, effective strategy for primary prevention is paramount. Secondary outcomes from the docosahexaenoic acid (DHA) to Optimise Mother Infant Outcome trial showed that maternal supplementation until delivery with omega-3 (ω-3) long chain polyunsaturated fatty acid (LCPUFA), predominantly as DHA, resulted in a 50% reduction in the incidence of EPTB and an increase in the incidence of post-term induction or post-term prelabour caesarean section due to extended gestation. We aim to determine the effectiveness of supplementing the maternal diet with ω-3 LCPUFA until 34 weeks’ gestation on the incidence of EPTB.Methods and analysisThis is a multicentre, parallel group, randomised, blinded and controlled trial. Women less than 20 weeks’ gestation with a singleton or multiple pregnancy and able to give informed consent are eligible to participate. Women will be randomised to receive high DHA fish oil capsules or control capsules without DHA. Capsules will be taken from enrolment until 34 weeks’ gestation. The primary outcome is the incidence of EPTB, defined as delivery before 34 completed weeks’ gestation. Key secondary outcomes include length of gestation, incidence of post-term induction or prelabour caesarean section and spontaneous EPTB. The target sample size is 5540 women (2770 per group), which will provide 85% power to detect an absolute reduction in the incidence of preterm birth of 1.16% (from 2.45% to 1.29%) between the DHA and control group (two sided α=0.05). The primary analysis will be based on the intention-to-treat principle.Trial registration numberAustralia and New Zealand Clinical Trial Registry Number: 2613001142729; Pre-results.

scholarly journals LABOR COURSE AND CONDITION OF NEWBORNS IN WOMEN WITH PLACENTAL DYSFUNCTION DUE TO GESTATIONAL ENDOTHELIOPATHY

World Science ◽  
2019 ◽  
Vol 2 (9(49)) ◽  
pp. 4-8
Author(s):  
V. V. Lazurenko ◽  
I. B. Borzenko ◽  
D. Yu. Tertyshnik
Keyword(s):  
Birth Weight ◽  
Preterm Birth ◽  
Caesarean Section ◽  
Fetal Growth ◽  
Fetal Distress ◽  
First Trimester ◽  
Control Group ◽  
Perinatal Complications ◽  
Placental Dysfunction ◽  
First Trimester Of Pregnancy

The purpose of the study is to evaluate the effect of placental dysfunction caused by gestational endotheliopathy on the course of labor and the condition of the newborn. The first group consisted of 70 patients with placental dysfunction with gestational endotheliopathy confirmed by laboratory-instrumental findings in the first trimester of pregnancy. The control group included 30 pregnant women with physiological gestational course. PD secondary to GE leads to preterm birth, fetal distress, increases the percentage of caesarean section, contributes to the delay of fetal growth and birth weight, poor infant status and perinatal complications.

scholarly journals Cod-Liver Oil Improves Metabolic Indices and hs-CRP Levels in Gestational Diabetes Mellitus Patients: A Double-Blind Randomized Controlled Trial

2019 ◽  
Vol 2019 ◽  
pp. 1-13
Author(s):  
Shuli Yang ◽  
Ruixin Lin ◽  
Lihui Si ◽  
Zhuo Li ◽  
Wenwen Jian ◽  
...  
Keyword(s):  
Diabetes Mellitus ◽  
Blood Glucose ◽  
Gestational Diabetes ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Cod Liver Oil ◽  
Perinatal Complications ◽  
Secondary Outcomes ◽  
Hs Crp

Objective. To investigate the effects of cod-liver oil on metabolic status and high-sensitivity C-reactive protein (hs-CRP) in patients with gestational diabetes mellitus (GDM). Methods. This study was a randomized, double-blinded, placebo-controlled trial with the allocation ratio of 1 : 1. The contents of EPA and DHA in cod-liver oil were measured using a gas chromatograph. A total of 550 GDM patients were randomly divided into the intervention group (cod-liver oil) and the control group (placebo, mineral oil), and both groups were given regular dietary care. Glycosylated hemoglobin A1c (HbA1c), fasting plasma glucose (FPG), 2-hour plasma glucose (2hPG), lipid profiles, homeostatic model assessment insulin resistance (HOMA-IR), and hs-CRP were measured. Primary outcomes were different in HbA1c, FPG, 2hPG, and HOMA-IR between the two groups after 4-week randomization. Secondary outcomes were the blood glucose levels and perinatal complications (pregnancy-induced hypertension, polyhydramnios, premature delivery, postpartum hemorrhage, postpartum infection, premature rupture of membranes, and cesarean section) between the two groups before and after 12-16 weeks of cod-liver oil intervention from middle pregnancy to late pregnancy. Results. EPA and DHA were the main components of cod-liver oil with 76 mg/mL and 150 mg/mL, respectively. There was no significant difference for primary outcomes in the levels of HbA1c, FPG, 2hPG, HOMA-IR, and lipid profiles between the two groups (P>0.05). For the secondary outcomes, the levels of HbA1c, FPG, 2hPG, triglyceride (TG), total cholesterol (TC), low-density lipoprotein cholesterol ratio (LDL-C), HOMA-IR, and hs-CRP in the intervention group were significantly lower than those in the control group (P<0.05). The incidence of perinatal complications in the intervention group was lower than that in the control group too (P<0.05). Conclusions. Cod-liver oil consumption effectively reduced the levels of blood glucose, lipid levels, hs-CRP, and HOMA-IR and the incidence of perinatal complications.

scholarly journals Docosahexaenoic Acid and Preterm Birth

2016 ◽  
Vol 69 (Suppl. 1) ◽  
pp. 29-34 ◽  
Author(s):  
Maria Makrides ◽  
Karen Best
Keyword(s):  
Preterm Birth ◽  
Preterm Births ◽  
Epidemiological Studies ◽  
Chain Polyunsaturated Fatty Acid ◽  
Omega 3 ◽  
Perinatal Complications ◽  
Increased Risk ◽  
Short And Long Term ◽  
Randomised Controlled ◽  
Dietary Agents

Preterm birth accounts for more than 85% of all perinatal complications and deaths. There are many short- and long-term consequences of being born too soon. These infants often require intensive care and are at increased risk of early morbidities often with life-long sequelae. Approximately 50% of all preterm births have unknown or unclear causes, and there are no effective primary prevention strategies in widespread clinical use. Epidemiological studies have observed an increased length of gestation in populations with high fish consumption. These findings have led to randomised controlled trials of omega-3 (n-3) long-chain polyunsaturated fatty acid (LCPUFA) supplementation which show that these dietary agents may delay the timing of birth and may have value as a prophylactic intervention in some women. This review presents the available evidence and discusses the relationship between prenatal n-3 LCPUFA supplementation during pregnancy and the incidence of preterm birth.

scholarly journals Long-chain polyunsaturated fatty acid (LC-PUFA) status in severe preeclampsia and preterm birth: a cross sectional study

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Rima Irwinda ◽  
Rabbania Hiksas ◽  
Aprilia Asthasari Siregar ◽  
Yudianto Budi Saroyo ◽  
Noroyono Wibowo
Keyword(s):  
Fatty Acid ◽  
Preterm Birth ◽  
Cross Sectional Study ◽  
Severe Preeclampsia ◽  
Chain Polyunsaturated Fatty Acid ◽  
Omega 3 ◽  
Sectional Study ◽  
Cross Sectional ◽  
Omega 6 ◽  
Long Chain

AbstractLong-Chain Polyunsaturated Fatty Acid (LCPUFA) is essential throughout pregnancy, since deficiency of LPUFA may linked to obstetrical complications. This study aimed to investigate LCPUFA status in severe preeclampsia and preterm birth. A cross sectional study was conducted in 104 pregnant women, which divided into normal pregnancy, severe preeclampsia and preterm birth groups. Serum percentage and concentration of total LCPUFA, omega-3, alpha-linolenic acid (ALA), eicosapentaenoic acid (EPA), docosahexaenoic acid (DHA), omega-6, linoleic acid (LA), and arachidonic acid (AA) were measured using gas chromatography/mass spectrometry. Receiver operating characteristic (ROC), bivariate and multivariate analysis were performed. Severe preeclampsia showed the highest concentration of total PUFA and the lowest DHA percentage, with significantly higher Omega-6/Omega-3 ratio (p = 0.004) and lower omega-3 index (p < 0.002) compared to control. Preterm birth showed the least omega-3 concentrations, with significantly low omega-6 derivates (LA (p = 0.014) and AA (p = 0.025)) compared to control. LCPUFA parameters have shown to increase the risk in both conditions, particularly ALA ≤ 53 µmol/L in preeclampsia with OR 5.44, 95%CI 1.16–25.42 and preterm birth with OR 4.68, 95%CI 1.52–14.38. These findings suggest that severe preeclampsia and preterm birth have an imbalance in LCPUFA status.

scholarly journals Effectiveness and cost-effectiveness of the PLAN-A intervention, a peer led physical activity program for adolescent girls: results of a cluster randomised controlled trial

2021 ◽  
Vol 18 (1) ◽  
Author(s):  
Russell Jago ◽  
Byron Tibbitts ◽  
Kathryn Willis ◽  
Emily Sanderson ◽  
Rebecca Kandiyali ◽  
...  
Keyword(s):  
Physical Activity ◽  
Cost Effectiveness ◽  
Randomised Controlled Trial ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Cluster Randomised Controlled Trial ◽  
Control Group ◽  
Cluster Randomised ◽  
Secondary Outcomes ◽  
Randomised Controlled

Abstract Background Physical activity is associated with improved health. Girls are less active than boys. Pilot work showed that a peer-led physical activity intervention called PLAN-A was a promising method of increasing physical activity in secondary school age girls. This study examined the effectiveness and cost-effectiveness of the PLAN-A intervention. Methods We conducted a cluster randomised controlled trial with Year 9 (13–14 year old) girls recruited from 20 secondary schools. Schools were randomly assigned to the PLAN-A intervention or a non-intervention control group after baseline data collection. Girls nominated students to be peer leaders. The top 18 % of girls nominated by their peers in intervention schools received three days of training designed to prepare them to support physical activity. Data were collected at two time points, baseline (T0) and 5–6 months post-intervention (T1). Participants wore an accelerometer for seven days to assess the primary outcome of mean weekday minutes of moderate-to-vigorous physical activity (MVPA). Multivariable mixed effects linear regression was used to estimate differences in the primary outcome between the two arms on an Intention-to-Treat (ITT) basis. Resource use and quality of life were measured and a within trial economic evaluation from a public sector perspective was conducted. Results A total of 1558 girls were recruited to the study. At T0, girls in both arms engaged in an average of 51 min of MVPA per weekday. The adjusted mean difference in weekday MVPA at T1 was − 2.84 min per day (95 % CI = -5.94 to 0.25) indicating a slightly larger decline in weekday MVPA in the intervention group. Results were broadly consistent when repeated using a multiple imputation approach and for pre-specified secondary outcomes and sub-groups. The mean cost of the PLAN-A intervention was £2817 per school, equivalent to £31 per girl. Economic analyses indicated that PLAN-A did not lead to demonstrable cost-effectiveness in terms of cost per unit change in QALY. Conclusions This study has shown that the PLAN-A intervention did not result in higher levels of weekday MVPA or associated secondary outcomes among Year 9 girls. The PLAN-A intervention should not be disseminated as a public health strategy. Trial registration ISRCTN14539759–31 May, 2018.

scholarly journals Hybrid Tele and In-Clinic Occupation Based Intervention to Improve Women’s Daily Participation after Breast Cancer: A Pilot Randomized Controlled Trial

2021 ◽  
Vol 18 (11) ◽  
pp. 5966
Author(s):  
Khawla Loubani ◽  
Rachel Kizony ◽  
Uzi Milman ◽  
Naomi Schreuer
Keyword(s):  
Breast Cancer ◽  
Cognitive Abilities ◽  
Controlled Trial ◽  
Intervention Group ◽  
Performance Measure ◽  
Control Group ◽  
Activity Levels ◽  
Emotional Symptoms ◽  
Short Period ◽  
Secondary Outcomes

Background: Women after breast cancer (BC) cope with decreased daily participation and quality of life (QOL) due to physical, cognitive, and emotional symptoms. This study examined a hybrid occupation-based intervention, Managing Participation with Breast Cancer (MaP-BC), to improve daily participation in their meaningful activities. Methods: Thirty-five women after BC phase were randomly allocated to the MaP-BC intervention (n = 18) or control (n = 17) group (standard care only). Assessments were administered at baseline (T1), 6-week (T2), and 12-week (T3) post-T1. Main outcome: perceived performance and performance-satisfaction with meaningful activities according to the Canadian Occupational Performance Measure. Secondary outcomes: retained activity levels (Activity Card Sort), QOL (Functional Assessment of Cancer Therapy-Breast), cognitive abilities (Montreal Cognitive Assessment and Behavior Rating Inventory of Executive Function), and upper-extremity functioning (Disability of Arm, Shoulder, Hand). Results showed significant interaction (group x time) effects for the primary outcome in performance, F(2,66) = 29.54, p = 0.001, ɳP2 = 0.472, and satisfaction, F(2,66) = 37.15, p = 0.000, ɳP2 = 0.530. The intervention group improved more in performance, t = 5.51, p = 0.0001, d = 1.298, and satisfaction, t = −5.32, p = 0.0001, d = 1.254, than the control group between T1 and T2. Secondary outcomes demonstrated within-group improvements. Conclusion: MaP-BC, a comprehensive occupation-based hybrid intervention tailored to women’s functional daily needs after BC, improved participation in meaningful activities within a short period.

scholarly journals A randomized controlled trial on a self-guided Internet-based intervention for gambling problems

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Lara Bücker ◽  
Josefine Gehlenborg ◽  
Steffen Moritz ◽  
Stefan Westermann
Keyword(s):  
Randomized Controlled Trial ◽  
Depressive Symptoms ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Group Differences ◽  
Control Group ◽  
Gambling Problems ◽  
Randomized Controlled ◽  
Secondary Outcomes ◽  
Internet Based Intervention

AbstractThe majority of individuals with problematic and pathological gambling remain untreated, and treatment barriers are high. Internet-based interventions can help to address existing barriers, and first studies suggest their potential for this target group. Within a randomized controlled trial (N = 150) with two assessment times (baseline and post-intervention), we aimed to investigate the feasibility, acceptance, and effectiveness of a self-guided Internet-based intervention targeted at gambling problems. We expected a significant reduction in gambling symptoms (primary outcome) and depressive symptoms as well gambling-specific dysfunctional thoughts (secondary outcomes) in the intervention group (IG) compared to a wait-list control group with access to treatment-as-usual (control group, CG) after the intervention period of 8 weeks. Results of the complete cases, per protocol, intention-to-treat (ITT), and frequent user analyses showed significant improvements in both groups for primary and secondary outcomes but no significant between-group differences (ITT primary outcome, F(1,147) = .11, p = .739, ηp2 < .001). Moderation analyses indicated that individuals in the IG with higher gambling and depressive symptoms, older age, and comorbid anxiety symptoms showed significant improvement relative to the CG. The intervention was positively evaluated (e.g., 96.5% rated the program as useful). Possible reasons for the nonsignificant between-group differences are discussed. Future studies should include follow-up assessments and larger samples to address limitations of the present study. Trial Registration ClinicalTrials.gov (NCT03372226), http://clinicaltrials.gov/ct2/show/NCT03372226, date of registration (13/12/2017).

Hysteroscopic management of a uterine caesarean scar defect (niche) in women with postmenstrual spotting: a randomised controlled trial

QJM ◽  
2021 ◽  
Vol 114 (Supplement_1) ◽  
Author(s):  
Hatem Hussein El-Gamal ◽  
Walid El-Basuony Mohammad ◽  
Ahmed Samir Mohamed Zeerban
Keyword(s):  
Quality Of Life ◽  
Caesarean Section ◽  
Controlled Trial ◽  
Intervention Group ◽  
Expectant Management ◽  
Control Group ◽  
Randomised Controlled ◽  
Caesarean Scar Defect ◽  
Interventional Group

Abstract Background Long-term complaints after caesarean section, such as postmenstrual spotting, dysmenorrhea, dyspareunia, or chronic pelvic pain, are frequently described in relation to the presence of a niche. A post-caesarean niche is defined as an indentation in the myometrium at the site of the uterine scar. Two independent prospective cohort studies reported that the presence of a niche after caesarean section increases the risk of postmenstrual spotting for more than 2 days from 15 to 30%. Postmenstrual spotting may be caused by a mechanical outflow problem, with the retention of menstrual blood in a niche, or by the accumulation of blood because of impaired uterine contractions at the site of the niche. Additionally, newly formed fragile vessels in the niche may play a role in the formation of blood or fluid in the niche and uterine cavity. Objective The aim of this study was to compare the effectiveness of a hysteroscopic niche resection versus no treatment in women with postmenstrual spotting and a uterine caesarean scar defect. Methods This trial is a randomised controlled trial that provides evidence for the (cost) effectiveness of hysteroscopic resection of a niche versus expectant management in women with niche related postmenstrual spotting. It was carried out on 28 cases divided into two equal group. The study was conducted at Ain Shams University on the women reporting postmenstrual spotting after a caesarean section. The primary outcome was the number of days of postmenstrual spotting 6 months after randomization. Secondary outcomes were spotting at the end of menstruation, intermenstrual spotting, dysuria, sonographic niche measurements, quality of life, women’s satisfaction, sexual function, and additional therapy. Outcomes were measured at 3 months and, also at 6 months after randomization. Results The results of this study show a significant improvement in interventional group after 3 months more than the control group in bleeding micturition characteristics which includes total days of spotting, spotting end of menstruation, intermenstral spotting, discomfort from spotting, dysmenorrhea and daily pain during micturition, after 6 months the two group improved but the interventional group was significantly higher than control group. Regarding the radiological assessment it was found that there was a significant improvement in intervention group more than the control group after 3 months, also the control group improved after 6 months also, but the intervention groups was significantly higher than the control group. The quality of life show a significant increasing in intervention group more than the control group after 3 months of intervention, at the end of follow up the intervention group was significantly higher in quality of life more than the control group. Conclusion A hysteroscopic niche resection reduces postmenstrual spotting, and the discomfort from spotting, compared with expectant management after 3 months of follow-up in women with a niche with a residual myometrium of at least 3 mm.

Effects of a home-based physical training and activity promotion program in community-dwelling older persons with cognitive impairment after discharge from rehabilitation: A randomized controlled trial

2022 ◽  
Author(s):  
Phoebe Ullrich ◽  
Christian Werner ◽  
Anton Schönstein ◽  
Martin Bongartz ◽  
Tobias Eckert ◽  
...  
Keyword(s):  
Physical Training ◽  
Controlled Trial ◽  
Intervention Group ◽  
Physical Capacity ◽  
Control Group ◽  
Promotion Program ◽  
Home Based ◽  
Activity Promotion ◽  
Secondary Outcomes

Abstract Background Older people with cognitive impairment (CI) are at high risk for mobility limitations and adverse outcomes after discharge from geriatric rehabilitation settings. Study aim was to estimate the effects of a specifically designed home-based physical training and activity promotion program on physical capacity, different aspects of physical activity (PA), and psychosocial status. Methods Patients with mild-to-moderate CI (Mini-Mental State Examination [MMSE]: 17-26 points) discharged home after rehabilitation were included in this randomized, double-blind, placebo-controlled trial with a 12-week intervention and 12-week follow-up period. The intervention group performed a CI-specific, autonomous, home-based strength, balance and walking training supported by tailored motivational strategies to foster training adherence and promote PA. The control group participated in an unspecific motor placebo activity. Primary outcomes were physical capacity (Short Physical Performance Battery [SPPB]) and PA (sensor-based activity time). Results Among 118 randomized participants (82.3±6.0 years) with CI (MMSE: 23.3±2.4) and high levels of multi-morbidity, those participants undergoing home-based training demonstrated superior outcomes to the control group in SPPB (mean difference between groups 1.9 points; 95%-CI: 1.0-2.8; p&lt;.001), with persistent benefits over the follow-up (1.3 points; 95%-CI: 0.4-2.2; p&lt;.001). There were no differences in PA across any time points. Among secondary outcomes, fear of falling and activity avoidance behavior were reduced in the intervention group at all time points, life-space mobility improved short-term. Conclusions Study results demonstrate clinically important benefits of an individually tailored autonomous physical training and activity promotion program on physical capacity and secondary outcomes in different domains in a vulnerable, multi-morbid population.

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