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Early Evaluation of the MAMAACT Trial

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University of Copenhagen

Status and phase

Completed
Phase 2
Phase 1

Conditions

Pregnancy Complications

Treatments

Behavioral: MAMAACT

Study type

Interventional

Funder types

Other

Identifiers

NCT04261400
MAMAACT#1

Details and patient eligibility

About

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.

Full 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.

Enrollment

2,000 patients

Sex

Female

Ages

13 to 50 years old

Volunteers

No 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.

Trial design

Primary purpose

Health Services Research

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

2,000 participants in 2 patient groups

MAMAACT
Experimental group
Description:
Post graduate training of midwives in intercultural communication and health education materials for the pregnant women.
Treatment:
Behavioral: MAMAACT
Control
No Intervention group
Description:
Care as usual

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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