The National Danish MAMAACT Intervention
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 4,153
- 试验地点
- 38
- 主要终点
- Actively engagement with health care providers
研究概览
简要总结
Inequalities in stillbirth, infant and child mortality as well as other reproductive health outcomes have been reported among ethnic minority groups in Denmark. The MAMAACT study aims to improve the communication between non-Western immigrant women and midwives regarding body symptoms that need prompt reaction, and thus improve perinatal health. 19 of 21 maternity wards in Denmark participate in the study. By simple randomization 10 maternity wards have been selected to the intervention group and 9 maternity wards to the control group. The intervention consist of post graduate training of midwives in intercultural competence and use of health education materials (leaflet and app) on pregnancy warning signs. The intervention will be implemented in the antenatal care from October 2018- September 2019. The training is expected to reach 350 midwives working with antenatal care and 27000 pregnant women, of whom 2700 are expected to be non-Western migrant women. The effect of the MAMAACT intervention will be analyzed by assessing women's ability to actively engage with health care providers (primary outcome), women's knowledge about warning signs of pregnancy complications and health system navigation using survey data. Secondary outcomes are 5-minute Apgar score, umbilical-cord blood gas analysis, transfer to a neonatal intensive care unit, gestational age at birth, fetal birthweight according to gestational age and ICD-10 code for sign of asphyxia.
MAMAACTs overall target group is all pregnant women, and the specific target group is women of non-Western origin. Therefore, the outcomes of the trial will be analysed for both the total population and for the effects among non-Western immigrant women specifically.
Hypothesis: Training of midwives in intercultural competence and increased attention to communication of warning signs of pregnancy during antenatal care will improve the communication and interaction between women and midwives, improve health literacy of the women and enable them to better access the relevant care in case of a pregnancy complication, which will then increase survival and health of newborn children.
详细描述
The intervention is a complex intervention and designed as a cluster randomised trial. 19 maternity wards participate and by simple randomization within thee groups of maternity wards according to the proportion of non-Western migrant women giving birth, 10 clusters are in the intervention group and 9 in the control group.
The effectiveness of the intervention will be analysed in a difference-in-difference design, where the change in outcomes from before to after intervention period at the intervention sites are compared to the change at the control sites. Cross sectional surveys will be conducted before and after the implementation of the intervention.
Participants for the pre-implementation survey will be enrolled from May to July 2018. Participants for the post-implementation survey will be enrolled from May to July 2019. Only participants from the post-implementation survey at the intervention sites will be exposed to the intervention. The start date for the enrollment of participants exposed to the intervention will therefore be May 1st 2019.
The primary trial outcome is studied using telephone surveys with pregnant women recruited through the antenatal care services. The questionnaire will include validated items on the health literacy dimension actively engagement with health care providers (5 items) and health system navigation (5 items). Women are recruited when they attend for the week 20 ultra sound scan and will be interviewed between pregnancy week 30+0 and 38+7. The questionnaires are managed in six languages (Danish, Arabic, English, Turkish, Somali and Urdu, and bilingual and trained interviewers conduct the interviews.
Using unpublished data from pregnant women at Hvidovre Hospital in 2016 (n=407), Danish born women are found to have a mean level of the relevant health literacy dimension on 4.16 and non-Western migrant women have a significantly lower mean at 3.97. The goal is that the MAMAACT intervention will to improve the mean level of the non-Western migrant women to the level of the Danish born women at baseline, thus an effect on 0.2 on the mean of the dimension are to be shown. A recent Danish cluster randomized trial aiming at improved breast feeding by improving the guidance of new mothers at maternity wards has reported intra-cluster correlation coefficients (ICC) under 0.005.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 13 Years 至 50 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Clusters: All maternity wards in Denmark defined as having one midwife heading the unit. Thus, Odense and Svendborg maternity wards are considered one cluster
- •Survey: Women attending the malformation scan in the specified calender weeks at the specific maternity ward, pregnancy week 18+0 to 22+0 during the malformation scan, able to participate in a phone interview in Danish, Arabic, English, Turkish, Somali or Urdu
排除标准
- •Cluster: All maternity wards invited
- •Survey: Women out of the gestational age range specified above, women who could not speak the selected languages
结局指标
主要结局
Actively engagement with health care providers
时间窗: Assessed among women in prenancy week 30+0 to 38+7
Increased mean score of the domain (5 item scale) among non-Western migrant women in Denmark. The Health Literacy domain of Actively engagement with health care providers, validated in the Health Literacy Questionnaire
次要结局
- Knowledge on pregnancy warning signs(Assessed among women in pregnancy week 30+0 to 38+7)
- ICD-10 code for sign of asphyxia(Assessed within the first minute after delivery)
- Apgar score at 5 minutes(Mean Apgar scores at five minutes after birth)
- Ability to navigate the health system(Assessed among women in pregnancy week 30+0 to 38+7)
- Umbilical-cord blood gas analysis(Umbilical-cord blood gas analysis taken after the delivery of the baby, within the 30 minutes)
- Transfer to a neonatal intensive care unit(Transferral at the day of delivery or the day after)
- Maternal pregnancy complications(Assessed from pregnancy week 12 up till one week after delivery)
- A composite score for stillbirth, neonatal death and neonatal near miss(Assessed according to the specific outcomes with the maximum range of 28 days after birth for neonatal death)
研究者
Sarah Fredsted Villadsen
Assistant Professor / Ph.D
University of Copenhagen