The MAMAACT Intervention

NCT03751774 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 4153

Last updated 2022-05-19

No results posted yet for this study

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.

Conditions

  • Health Literacy
  • Stillbirth
  • Apgar; 0-3 at 1 Minute
  • Apgar; 4-7 at 1 Minute
  • Asphyxia

Interventions

BEHAVIORAL

MAMAACT

Post graduate training and health education materials

Sponsors & Collaborators

  • 19 maternity wards

    collaborator AMBIG
  • Migrant medical clinics (Odense and Hvidovre)

    collaborator UNKNOWN
  • TrygFonden, Denmark

    collaborator INDUSTRY
  • Østifterne

    collaborator UNKNOWN
  • Danske Regioner

    collaborator OTHER
  • Neighbourhood mothers

    collaborator UNKNOWN
  • University College Copenhagen

    collaborator OTHER
  • University of Copenhagen

    lead OTHER

Principal Investigators

  • Sarah F Villadsen, Ph.d. · University of Copenhagen

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
13 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-05-01
Primary Completion
2019-12-01
Completion
2019-12-01

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03751774 on ClinicalTrials.gov