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Early Evaluation of the MAMAACT Trial

Primary Purpose

Pregnancy Complications

Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
MAMAACT
Sponsored by
University of Copenhagen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Pregnancy Complications

Eligibility Criteria

13 Years - 50 Years (Child, Adult)FemaleDoes not accept healthy volunteers

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

    First Posted
    February 4, 2020
    Last Updated
    February 6, 2020
    Sponsor
    University of Copenhagen
    Collaborators
    Hvidovre University Hospital, The Danish Council for Strategic Research
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    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

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    Early Evaluation of the MAMAACT Trial

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