Early Evaluation of the MAMAACT Trial
Primary Purpose
Pregnancy Complications
Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
MAMAACT
Sponsored by
About this trial
This is an interventional health services research trial for Pregnancy Complications
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
MAMAACT
Control
Arm Description
Post graduate training of midwives in intercultural communication and health education materials for the pregnant women.
Care as usual
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
Full Information
NCT ID
NCT04261400
First Posted
February 4, 2020
Last Updated
February 6, 2020
Sponsor
University of Copenhagen
Collaborators
Hvidovre University Hospital, The Danish Council for Strategic Research
1. Study Identification
Unique Protocol Identification Number
NCT04261400
Brief Title
Early Evaluation of the MAMAACT Trial
Official Title
MAMAACT Intervention for Improved Reproductive Health - a Feasibility Study
Study Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
January 1, 2014 (Actual)
Primary Completion Date
June 1, 2015 (Actual)
Study Completion Date
June 1, 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Copenhagen
Collaborators
Hvidovre University Hospital, The Danish Council for Strategic Research
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pregnancy Complications
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
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)
Allocation
Non-Randomized
Enrollment
2000 (Actual)
8. Arms, Groups, and Interventions
Arm Title
MAMAACT
Arm Type
Experimental
Arm Description
Post graduate training of midwives in intercultural communication and health education materials for the pregnant women.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Care as usual
Intervention Type
Behavioral
Intervention Name(s)
MAMAACT
Intervention Description
Improved communication regarding warning signs of pregnancy complications
Primary Outcome Measure Information:
Title
Womens satisfaction with midwifery based antenatal care
Description
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).
Time Frame
Assessed among women in pregnancy week 27+0 to 31+6
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
Pregnant women
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
32075593
Citation
Johnsen H, Ghavami Kivi N, Morrison CH, Juhl M, Christensen U, Villadsen SF. Addressing ethnic disparity in antenatal care: a qualitative evaluation of midwives' experiences with the MAMAACT intervention. BMC Pregnancy Childbirth. 2020 Feb 19;20(1):118. doi: 10.1186/s12884-020-2807-4.
Results Reference
derived
Learn more about this trial
Early Evaluation of the MAMAACT Trial
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