Early Evaluation of the MAMAACT Trial

Study Overview
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Brief Summary
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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
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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.

Official Title
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MAMAACT Intervention for Improved Reproductive Health - a Feasibility Study

Conditions
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Pregnancy Complications

Intervention / Treatment
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* Behavioral: MAMAACT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pregnant in gestational week 27+0-31+6 , affiliated to Hvidovre hospital, seen for antenatal care during recruitment weeks. Exclusion Criteria: Not speaking Danish, English, Urdu, Turkish, Somali, Persian or Arabic.

Ages Eligible for Study
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Minimum Age: 13 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MAMAACT<br>Post graduate training of midwives in intercultural communication and health education materials for the pregnant women. | Behavioral: MAMAACT<br>* Improved communication regarding warning signs of pregnancy complications<br>|
| No Intervention: Control<br>Care as usual | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Womens satisfaction with midwifery based antenatal care | Changed level of satisfaction with midwifery based antenatal care among pregnant women. Satisfaction was measured by the question: I was satisfied with the conversation that I had with the midwife with four response categories: Strongly agree, Agree, Disagree, or Strongly disagree. This item was an adapted version of the item from the Maternity study in Jimma, Ethiopia (Villadsen, S.F., Negussie, D., GebreMariam, A. et al. Antenatal care strengthening for improved quality of care in Jimma, Ethiopia: an effectiveness study. BMC Public Health 15, 360 (2015). https://doi.org/10.1186/s12889-015-1708-3). | Assessed among women in pregnancy week 27+0 to 31+6 |