Early Evaluation of the MAMAACT Trial
Condition: Pregnancy Complications
MeSH terms: Pregnancy Complications
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The MAMAACT#1 project's aim was to reduce ethnic disparity in stillbirth and infant death by
      improving the management of pregnancy complications through timely and appropriate response
      to warning signs of pregnancy. The intervention consisted of a training program for midwives
      and health education materials for pregnant women. The aim of the feasibility trial was to
      analyze the acceptability and feasibility of the MAMAACT intervention using mini-group
      interviews with midwives and to pilot outcome evaluation using surveys.
    

Detailed description: 
      The MAMAACT project's aim was to reduce ethnic disparity in stillbirth and infant death by
      improving the management of pregnancy complications through timely and appropriate response
      to warning signs of pregnancy. The intervention was co-created with midwives at Hvidovre
      Hospital, the largest maternity ward in Denmark. The intervention consisted of a 5-hour
      training session for midwives in intercultural communication followed by three dialogue
      meetings in smaller groups. The first midwife visit was extended with 5 minutes allowing for
      more communication and health education on body symptoms. The women were given a leaflet and
      a mobile application at this first visit that were describing when and how to respond to
      warning signs during pregnancy. Both the leaflet and application were available in Danish,
      Arabic, Persian, English, Somali, Turkish, and Urdu.

      The intervention was a complex intervention, and this phase was a feasibility study preceding
      a national trial. This feasibility trial was tested at one hospital 2014-2015. The national
      trial 2017-2021 is registered with ClinicalTrials.gov Identifier: NCT03751774.

      The hospital had four antenatal clinics and the intervention was implemented at two clinics,
      while two served as control clinics. The MAMAACT leaflet and app were distributed to all
      pregnant women at the two intervention clinics, equivalent n=2000, attending antenatal care
      during the test period.

      The aim of the feasibility trial was to analyze the acceptability and feasibility of the
      trial and to pilot outcome evaluation using surveys in a difference in difference design. The
      acceptability and feasibility of the intervention were evaluated using mini-groups interviews
      with midwives in the intervention arm. The difference in difference study was piloted
      comparing change in outcomes of women from the intervention arm from before the intervention
      to after the intervention relative to the change in the control arm. Survey assessed outcomes
      were women's' knowledge about warning signs of pregnancy complications, health system
      navigation and satisfaction with the midwifery based antenatal care.
    

Intervention name(s): MAMAACT
Intervention type(s): Behavioral
Intervention description(s): Improved communication regarding warning signs of pregnancy complications
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: The intervention package was provided to midwives working at two specific antenatal care facilities and the women attending care at these facilities received the health education material.
Masking: None (Open Label)
Primary purpose: Health Services Research