Ingela Rådestad1, Anna Akselsson2, Susanne Georgsson3, Helena Lindgren4, Karin Pettersson5, Gunnar Steineck6. 1. Sophiahemmet University, Stockholm, Sweden. Electronic address: ingela.radestad@shh.se. 2. Sophiahemmet University, Stockholm, Sweden; Department of Women and Children's Health, Karolinska Institutet, Stockholm, Sweden. 3. Sophiahemmet University, Stockholm, Sweden; Department of Clinical Science, Intervention and Technology, Karolinska Institutet, Stockholm, Sweden. 4. Department of Women and Children's Health, Karolinska Institutet, Stockholm, Sweden. 5. Department of Clinical Science, Intervention and Technology, Karolinska Institutet, Stockholm, Sweden. 6. Division of Clinical Cancer Epidemiology, Department of Oncology, Institute of Clinical Sciences, Sahlgrenska Academy at the University of Gothenburg, Gothenburg, Sweden; Department of Oncology and Pathology, Division of Clinical Cancer Epidemiology, Karolinska Institutet, Stockholm, Sweden.
Abstract
BACKGROUND: Shortening 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. METHODS: This 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. RESULTS: We 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. CONCLUSION: The work up to now follows the outlined time schedule. We expect to present the first results concerning the effects of Mindfetalness during 2018.
RCT Entities:
BACKGROUND: Shortening 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. METHODS: This 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. RESULTS: We 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. CONCLUSION: The work up to now follows the outlined time schedule. We expect to present the first results concerning the effects of Mindfetalness during 2018.
Authors: Alexander E P Heazell; Christopher J Weir; Sarah J E Stock; Catherine J Calderwood; Sarah Cunningham Burley; J Frederik Froen; Michael Geary; Alyson Hunter; Fionnuala M McAuliffe; Edile Murdoch; Aryelly Rodriguez; Mary Ross-Davie; Janet Scott; Sonia Whyte; Jane E Norman Journal: BMJ Open Date: 2017-08-11 Impact factor: 2.692
Authors: Jane E Norman; Alexander E P Heazell; Aryelly Rodriguez; Christopher J Weir; Sarah J E Stock; Catherine J Calderwood; Sarah Cunningham Burley; J Frederik Frøen; Michael Geary; Fionnuala Breathnach; Alyson Hunter; Fionnuala M McAuliffe; Mary F Higgins; Edile Murdoch; Mary Ross-Davie; Janet Scott; Sonia Whyte Journal: Lancet Date: 2018-09-27 Impact factor: 79.321
Authors: Anna Akselsson; Helena Lindgren; Susanne Georgsson; Karin Pettersson; Viktor Skokic; Ingela Rådestad Journal: Glob Health Action Date: 2020-12-31 Impact factor: 2.640