Early Evaluation of the MAMAACT Trial

NCT04261400 | Completed Phase 1 DMC

• 1 other identifier: MAMAACT#1
• Study Type: interventional
• Target: 2,000
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Pregnancy Complications

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

MAMAACT

EXPERIMENTAL

Post graduate training of midwives in intercultural communication and health education materials for the pregnant women.

Behavioral: MAMAACT

Control

NO INTERVENTION

Care as usual

Interventions

MAMAACT BEHAVIORAL

Improved communication regarding warning signs of pregnancy complications

MAMAACT

Eligibility Criteria

• Age: 13 Years - 50 Years
• Gender Eligibility Details: Pregnant women
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Pregnant in gestational week 27+0-31+6 , affiliated to Hvidovre hospital, seen for antenatal care during recruitment weeks.

You may not qualify if:

• Not speaking Danish, English, Urdu, Turkish, Somali, Persian or Arabic.

Sponsors & Collaborators

• University of Copenhagen: lead
• Hvidovre University Hospital: collaborator
• The Danish Council for Strategic Research: collaborator

Related Publications (1)

• 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.

  PMID: 32075593 DERIVED

MeSH Terms

Conditions

Pregnancy Complications

Condition Hierarchy (Ancestors)

Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor / Ph.D

Model Details: 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.

Study Record Dates

• First Submitted: February 4, 2020
• First Posted: February 7, 2020
• Study Start: January 1, 2014
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: February 7, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share