Rationale, study protocol and the cluster randomization process in a controlled trial including 40,000 women investigating the effects of mindfetalness

Abstract

BackgroundShortening pre-hospital delay may decrease stillbirth rates and rates of babies born with a compromised health. Stillbirth may be preceded by a decrease in fetal movements. Mindfetalness has been developed as a response to the shortcomings of kick-counting for the monitoring of fetal movements by the pregnant woman. We do not know if practicing Mindfetalness may diminish pre-hospital delay. Nor do we know if practicing Mindfetalness may increase or decrease the percentage of women seeking health care for unfounded, from a medical perspective, worry for her fetus' well-being. MethodsThis article describes the rationale, study protocol and the randomization process for a planned study randomly allocating 40,000 pregnant women to receive, or not receive, proactive information about practicing Mindfetalness. The unit of randomization is 63 antenatal clinics in the Stockholm area. Midwives in the antenatal clinics randomized to Mindfetalness will verbally inform about practicing Mindfetalness, hand out brochures (printed in seven languages) and inform about a website giving information about Mindfetalness. Routine care will continue in the control clinics. All information for the analyses, including the main endpoint of an Apgar score below 7 (e.g., 0–6 with stillbirth giving a score of 0), measured five minutes after birth, will be retrieved from population-based registers. ResultsWe have randomized 33 antenatal clinics to Mindfetalness and 30 to routine care. In two clinics a pilot study has been performed. One of the clinics randomly allocated to inform about Mindfetalness will not do so (but will be included in the intention-to-treat analysis). In October 2016 we started to recruit women for the main study. ConclusionThe work up to now follows the outlined time schedule. We expect to present the first results concerning the effects of Mindfetalness during 2018.