Feasibility study protocol of a pragmatic, randomised controlled pilot trial: membrane sweeping to prevent post-term pregnancy-the MILO Study.

BACKGROUND: Post-term pregnancy is associated with an increased risk of maternal complications, respiratory distress and trauma to the neonate. Amniotic membrane sweeping has been recommended as a simple procedure to promote the spontaneous onset of labour. However, despite its widespread use, there is an absence of evidence on (a) its effectiveness and (b) its optimal timing and frequency. The primary aim of the MILO Study is to inform the optimal design of a future definitive randomised trial to evaluate the effectiveness (including optimal timing and frequency) of membrane sweeping to prevent post-term pregnancy. We will also assess the acceptability and feasibility of the proposed trial interventions to clinicians and women (through focus group interviews). METHODS/DESIGN: Multicentre, pragmatic, parallel-group, pilot randomised controlled trial with an embedded factorial design. Pregnant women with a live, singleton foetus ≥ 38 weeks gestation; cephalic presentation; longitudinal lie; intact membranes; English speaking and ≥ 18 years of age will be randomised in a 2:1 ratio to membrane sweep versus no membrane sweep. Women allocated randomly to a sweep will then be randomised further (factorial component) to early (from 39 weeks) versus late (from 40 weeks) sweep commencement and a single versus weekly sweep. The proposed feasibility study consists of four work packages, i.e. (1) a multicentre, pilot randomised trial; (2) a health economic analysis; (3) a qualitative study; and (4) a study within the host trial (a SWAT). Outcomes to be collected include recruitment and retention rates, compliance with protocol, randomisation and allocation processes, attrition rates and cost-effectiveness. Focus groups will be held with women and clinicians to explore the acceptability and feasibility of the proposed intervention, study procedures and perceived barriers and enablers to recruitment. DISCUSSION: The primary aim of the MILO Study is to inform the optimal design of a future definitive randomised trial to evaluate the effectiveness (including optimal timing and frequency) of membrane sweeping to prevent post-term pregnancy. Results will inform whether and how the design of the definitive trial as originally envisaged should be delivered or adapted. TRIAL REGISTRATION: ClinicalTrials.gov NCT04307199 . Registered on 12 March 2020.

Messages about calcium and weight in Canadian women's magazines.

PURPOSE: Osteoporosis affects 1.4 million Canadians. Maximizing bone mass by age 30 may reduce this risk. Because calcium intake and body weight are both associated with bone mass, and many Canadian women report that they obtain nutrition information from magazines, we compared the frequency of calcium and body weight messages in Chatelaine and Flare, Canadian magazines for mature versus younger women, respectively. METHODS: Using keywords, we identified relevant advertisements and articles in all issues of Chatelaine and Flare for 2000 to 2001. Data were analyzed using paired t-tests and Wilcoxon signed-rank sum tests. RESULTS: Chatelaine had more calcium and weight messages per 100 pages than did Flare (significant only for calcium, p

Reliability and Validity of the Three-Day Estimated Record of Food Intake Provided by Parents and Caregivers of Preschool Children in Dual-Earner Families.

This study examined the reliability and validity of the three-day estimated record provided by parents and caregivers of preschoolers. Subjects included a random sample of 146 preschoolers (24-47 months) in dual-earner families. Parents and caregivers completed a three-day estimated record for each child. Six weeks later they were randomly assigned into either a group completing a second estimated record (Group1) as a test of reliability, or a group completing a weighed record (Group 2) as a test of validity. For Group 1, significant differences (P<0.05) in group mean intakes of energy and four of 10 nutrients were found; however, the magnitude of the differences was considered small. Similar results were found for Group 2. Intra-person variation in energy and nutrient intakes exceeded inter-person variation (60-90% versus 10-40% of the total variation). The three-day estimated record provided by parents and caregivers of preschool children is reliable and valid at the group level, however, intra-person variation affects its use at the individual level. These results have implications for the design of future studies of preschool children with employed parents where food intake must be recorded by multiple caregivers. Researchers and practitioners are challenged to design new, simpler methods to measure food intake that lend themselves to the varied eating situations of many preschool children today.