The MAMAACT Intervention
Condition: Health Literacy; Stillbirth; Apgar; 0-3 at 1 Minute; Apgar; 4-7 at 1 Minute; Asphyxia
MeSH terms: Stillbirth; Asphyxia
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.

      For the sample size calculation an estimation with 10 cluster in the control group and 10
      clusters in the intervention group were used, however after recruitment and randomization 9
      wards were in the control group and 10 in the intervention group. With an ICC on 0.005 with
      10 clusters in the intervention arm and 10 clusters in the control arm an effect on 0.1 with
      a strength of 80 % can be detected if data from 2580 of the total population before and after
      the intervention (1290 from the intervention before and after and 1290 from the control group
      before and after) is collected.

      With an ICC on 0.005 with 10 clusters in the intervention arm and 10 clusters in the control
      arm an effect on 0.2 with a strength of 80 % can be detected if data is collected from 500
      non-Western women before and after the intervention (250 from the intervention both before
      and after and 250 from the control group both before and after).

      Based on telephone survey data, effects on the skills in health system navigation among the
      women will also be analysed.

      The overall effects of the MAMAACT intervention on stillbirth and neonatal health will be
      analysed by the medical birth registry and obstetric databases. Stillbirth is defined as
      death of a child without any signs of life after 22 completed weeks of gestation. Neonatal
      death is defined as death of a child after live birth before 1 months of age. No significant
      effects on these outcomes are expected due to low numbers in the short intervention period.
      Secondary trial 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, ICD-10 code for sign of asphyxia, and pregnancy complications
      (preeclampsia).

      All effectiveness analysis will be using an intention-to-treat approach and will account for
      the clustering of individuals and potential confounding in a controlled mixed effect
      regression.

      The implementation of the intervention will be analyzed using qualitative data. The resarch
      questions are: How do midwives and non-Western immigrant women react to the MAMAACT
      intervention across Denmark? Which barriers exist in the organisation of antenatal care, and
      how do they affect the national implementation of the MAMAACT intervention? What are
      non-Western immigrant women's everyday life conditions in Denmark, and how do they affect
      women's responses to potential pregnancy complications?
    

Intervention name(s): MAMAACT
Intervention type(s): Behavioral
Intervention description(s): Post graduate training and health education materials
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Clusters (maternity wards) are randomized to either intervention or control (standard ANC). Intervention coverage 27000. Data collection for the primary and secondary trial outcomes includes 1.921 interviewed participants in the pre-intervention survey and 2.232 interviewed participants in the post-intervention survey.
Masking: None (Open Label)
Primary purpose: Prevention