The MAMAACT Intervention

NCT03751774 | Completed

• 1 other identifier: MAMAACT
• Study Type: interventional
• Target: 4,153
• Locations: 1 country
• Sites: 19

Brief 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

Outcome Measures

Primary Outcomes (1)

• Actively engagement with health care providers

  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

  Assessed among women in prenancy week 30+0 to 38+7

Secondary Outcomes (8)

• 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

• Knowledge on pregnancy warning signs

  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

Study Arms (2)

MAMAACT

EXPERIMENTAL

Training of midwives in intercultural communication. A 6 hours course and 2 one hour booster sessions. Distribution of health education materials on warnings signs of pregnancy and health system navigation to pregnant women during antenatal care visits.

Behavioral: MAMAACT

Control

NO INTERVENTION

Care as usual

Interventions

MAMAACT BEHAVIORAL

Post graduate training and health education materials

MAMAACT

Eligibility Criteria

• Age: 13 Years - 50 Years
• Gender Eligibility Details: Pregnant women
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Cluster: All maternity wards invited
• Survey: Women out of the gestational age range specified above, women who could not speak the selected languages

Sponsors & Collaborators

• University of Copenhagen: lead
• 19 maternity wards: collaborator
• Migrant medical clinics (Odense and Hvidovre): collaborator
• TrygFonden, Denmark: collaborator
• Østifterne: collaborator
• Danske Regioner: collaborator
• Neighbourhood mothers: collaborator
• University College Copenhagen: collaborator

Study Sites (19)

The maternity ward in Aabenraa, Sygehus Soenderjylland

Aabenraa, 6200, Denmark

Location

The maternity ward in Aalborg, Aalborg Universitetshospital

Aalborg, 9100, Denmark

Location

The maternity ward in Aarhus, Aarhus Universitetshospital

Aarhus, 8200, Denmark

Location

The maternity ward in Esbjerg, Sydvestjysk Sygehus

Esbjerg, 6700, Denmark

Location

The maternity ward in Herlev, Herlev Hospital

Herlev, 2730, Denmark

Location

The maternity ward in Herning, Hospitalsenheden Vest

Herning, 7400, Denmark

Location

The maternity ward in Hillerød, Nordsjællandshospital Hillerød

Hillerød, 3400, Denmark

Location

The maternity ward in Hjoerring, Regionshospitalet Nord

Hjørring, 9800, Denmark

Location

The maternity ward in Holbaek, Holbaek Sygehus

Holbæk, 4300, Denmark

Location

The maternity ward in Horsens, Regionshospitalet Horsens

Horsens, 8700, Denmark

Location

The maternity ward in Hvidovre, Hvidovre hospital

Hvidovre, 2650, Denmark

Location

The maternity ward in Kolding, Sygehus Lillebaelt

Kolding, 6000, Denmark

Location

The maternity ward in Nykøbing Falster, Nykøbing Falster Sygehus

Nykøbing Falster, 4800, Denmark

Location

The maternity ward in Næstved, Næstved Sygehus

Næstved, 4700, Denmark

Location

The maternity ward in Odense, Odense Universitetshospital

Odense, 5000, Denmark

Location

The maternity ward in Randers, Regionshospitalet Randers

Randers, 8930, Denmark

Location

The maternity ward in Roskilde, Sjaellands Universitetshospital Roskilde

Roskilde, 4000, Denmark

Location

The maternity ward in Bornholm, Bornholms Hospital

Rønne, 3700, Denmark

Location

The maternity ward in Viborg, Regionshospitalet Viborg

Viborg, 8800, Denmark

Location

Related Publications (1)

• Rasmussen TD, Nybo Andersen AM, Ekstrom CT, Jervelund SS, Villadsen SF. Improving health literacy responsiveness to reduce ethnic and social disparity in stillbirth and infant health: A cluster randomized controlled effectiveness trial of the MAMAACT intervention. Int J Nurs Stud. 2023 Aug;144:104505. doi: 10.1016/j.ijnurstu.2023.104505. Epub 2023 May 1.

  PMID: 37267853 DERIVED

MeSH Terms

Conditions

Stillbirth; Asphyxia

Condition Hierarchy (Ancestors)

Fetal Death; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Wounds and Injuries

Study Officials

• Sarah F Villadsen, Ph.d.

  University of Copenhagen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor / Ph.D

Model Details: 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.

Study Record Dates

• First Submitted: November 12, 2018
• First Posted: November 23, 2018
• Study Start: May 1, 2019
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: May 19, 2022

Record last verified: 2022-05

Locations

DK (19)