Early Evaluation of the MAMAACT Trial

Pregnancy Complications Clinical Trial

Official title:

MAMAACT Intervention for Improved Reproductive Health - a Feasibility Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04261400
• Other study ID #: MAMAACT#1
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: January 1, 2014
• Est. completion date: June 1, 2015

Study information

• Verified date: February 2020
• Source: University of Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2000
• Est. completion date: June 1, 2015
• Est. primary completion date: June 1, 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 13 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pregnancy Complications

Intervention

Behavioral:
• MAMAACT
Improved communication regarding warning signs of pregnancy complications

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
University of Copenhagen	Hvidovre University Hospital, The Danish Council for Strategic Research

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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