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NCT Number: NCT07806942

Evaluation of a Health Mediation Program in the Maternity Ward.

The first months of life are considered a critical period that has a lasting impact on a child's future health.

Breastfeeding is one of the fundamental factors contributing to healthy growth in children. It is reducing infant mortality, and supporting neurocognitive development.

As part of the Nutri Pou Ti'moun program, a study on breastfeeding practices was conducted in French Guiana in 2024 to assess the current state of affairs.

A complementary qualitative study of 15 mothers in situations of multidimensional vulnerability revealed barriers to exclusive breastfeeding, such as the perception of a lack of milk, the newborn's perceived refusal to breastfeed, or a lack of support from family and friends.

The findings of these 2 studies encourage the investigators to support mothers in their choice to breastfeed from the moment they give birth, so that infant feeding practices align more closely with national and international recommendations and are as beneficial as possible for the child's health.

The objective of this study is to compare the rate of exclusive breastfeeding at 1 month between women who received the intervention (exposed group) and those who did not (unexposed group).

The study hypothesis is that the health intervention will improve the rate of exclusive breastfeeding.

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Key information

Sex eligibility

Female

Study type

Observational

Primary location

Centre hospitalier de Cayenne

Cayenne, Guyane, 97300, French Guiana

Location status: Recruiting

Location contact

Célia Célia BASURKO, MD

CONTACT

[email protected]

+594594395050

About this study

The first months of life are considered a critical period that has a lasting impact on a child's future health.

Breastfeeding is one of the fundamental factors contributing to healthy growth in children. Its benefits are well established in the literature in terms of preventing infections, reducing infant mortality, and supporting neurocognitive development.

As part of the Nutri Pou Ti'moun program, a study on breastfeeding practices was conducted in French Guiana in 2024 to assess the current state of affairs. Between March and October 2024, 382 mother-child pairs were included in this study. The results revealed that the majority of mothers had breastfed their children (91.6%) during the first year of life, but only 1 in 2 mothers had breastfed exclusively. Nearly 40% practiced mixed feeding upon discharge from the maternity ward. The study revealed that one in two women had received breastfeeding support from healthcare professionals at the maternity ward. This support tended to have a positive impact on the continuation of breastfeeding beyond 6 months. The use of formula milk supplements during the hospital stay, however, had a negative impact on the continuation of exclusive breastfeeding for at least 4 months.

A complementary qualitative study of 15 mothers in situations of multidimensional vulnerability revealed barriers to exclusive breastfeeding, such as the perception of a lack of milk, the newborn's perceived refusal to breastfeed, or a lack of support from family and friends.

These findings therefore encourage the investigators to support mothers in their choice to breastfeed from the moment they give birth, so that infant feeding practices align more closely with national and international recommendations and are as beneficial as possible for the child's health.

Furthermore, the sociodemographic characteristics of pregnant and breastfeeding women in French Guiana, as revealed by previous studies, highlight numerous vulnerabilities: one in three women experiences food insecurity during pregnancy; 12.5% of pregnancies occur before the age of 20 (compared to 1.3% in mainland France); 26% of pregnancies are not covered by PUMa, and 39% have a high multidimensional vulnerability index (compared to 5.3% in mainland France). Thus, the context of high vulnerability in perinatal care in French Guiana calls for the implementation of measures to combat social health inequalities. Health mediation is one such measure.

The investigators therefore propose the early integration of health mediation around childbirth in maternity wards.

The objective of this study is to compare the rate of exclusive breastfeeding at 1 month between women who received the intervention (exposed group) and those who did not (unexposed group).

The study hypothesis is that the health intervention will improve the rate of exclusive breastfeeding.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Women who gave birth at the French Guiana University Hospital Center

Exclusion criteria

  • Women refusal to participate to the study or lack of opposition collected
  • lack of authorization from legal representatives for underage women or from legal guardians for women under legal protection
  • foetal death, stillbirth, or neonatal death
  • feeding with formula from birth

Treatment and study plan

postpartum breastfeeding support from a health mediator

Other

This pilot mediation program consists of the following activities:

  • Supporting healthcare teams in providing postpartum care for women, particularly those in vulnerable situations.
  • Providing in-room support to women to assist them with breastfeeding in collaboration with the healthcare teams. The content of the support is tailored to the woman's needs and follows national guidelines. This support may be provided multiple times during the hospital stay. This individual in-room support is provided at the request of the woman and/or the healthcare team. The initial request and the content of the intervention are recorded in the woman's electronic medical record.
  • Participate weekly in the childbirth and parenting preparation workshop on breastfeeding, organized by the maternity ward and led by midwives and/or childcare assistants.

routine health care without health mediation

Other

routine health care for postpartum breastfeeding

Primary outcomes

  1. Rate of exclusive breastfeeding at 1 month postpartum in the group of women who received health mediation support (exposed group) and in the group of women who did not receive such support (unexposed group).

    Time frame: 1 month

    Measurement of the rate of exclusive breastfeeding using a questionnaire administred to mothers included in the study

Secondary outcomes

  1. Rate of exclusive breastfeeding

    Time frame: 1 month; 3 months

    Measurement of the rate of exclusive breastfeeding through a questionnaire administred to mothers

  2. Duration of exclusive breasfeeding

    Time frame: 1 month; 3 months

    Measurement of the duration of breastfeeding through a questionnaire administred to mothers

  3. Characteristics of the exposed group, including socioeconomic and medical data and the level of health literacy.

    Time frame: At enrollment

    Description of the socioeconomics data through a questionnaire administred to mothers, and collection of medical data in the electronic medical records

  4. Level of satisfaction within the maternity ward

    Time frame: At enrollment

    Score of satisfaction based on answers to a questionnaire administred to mothers included in the study within the maternity ward

  5. Level of support for breastfeeding

    Time frame: At enrollment

    Score of level of support to encourage breastfeeding obtained through a questionnaire administred to mothers included in the study

  6. Differences in breastfeeding rates measured in the MediMAT study compared to those measured in the ANJE Nutri study

    Time frame: 1 month; 3 months

    Calculation of breastfeeding rate calculated in the MediMAT study and comparison with breastfeeding rate calculated in the ANJE Nutri study

  7. "Self-efficacy" in relation to breastfeeding

    Time frame: 1 month

    Measurement of "self-efficacy" in relation to breastfeeding through a questionnaire administred to mothers

  8. Difference of feasibility of the integration of mediation into their service.

    Time frame: At study start and at the end of enrollment in the study (May 2026 and May 2027)

    Measurement of the difference of feasibility of the integration of mediation into their services through a questionnaire administred to healthcare staff

  9. Changes in patients' breastfeeding practices, in the postpartum period and one year after the integration of mediation in the postpartum period.

    Time frame: 12 months

    Measurement of changes in patients' breastfeeding practices, one year after the integration of mediation in the postpartum period through a questionnaire administred to mothers

  10. Changes in professional practices for supporting patients before the integration of mediation during postpartum period in the service, and one year after the integration of mediation

    Time frame: Before the integration of the mediation in the postpartum in the service and 12 months after the integration

    Measurement of changes in professional practices for supporting patients before the integration of mediation during postpartum period in the service, and one year after the integration of mediation, through a questionnaire administred to healthcare professionals

Study contacts

Contact information is provided by the study sponsor or research team.

Célia BASURKO, MD

CONTACT

[email protected]

+594594395050

Sponsors and collaborators

Lead sponsor

Centre Hospitalier de Cayenne

Other

Registry information

Acronym: MédiMAT

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Sep 8, 2026
Registry last updated
Sep 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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