ClinicalTrials.gg
RecruitingNCT07806942MédiMATUpdated Sep 8, 2026

Evaluation of a Health Mediation Program in the Maternity Ward.

An observational study in Breast Feeding, Exclusive, sponsored by Centre Hospitalier de Cayenne. Recruiting at 1 site in French Guiana. Open to female participants, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-08.

Sponsored by Centre Hospitalier de Cayenne · Observational

From the registry’s dates

  • Started May 2026; still recruiting 5 months later.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
960
Sex
Female
01

Study summary

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.

Read the detailed description

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.

02

Conditions studied

  • Breast Feeding, Exclusive

Keywords

  • mediation
  • breastfeeding
  • post-partum
  • population health intervention research
03

In context

Breast Feeding

1,081 studies on the registry are indexed under Breast Feeding; 217 are open to participants now.

This study's planned enrollment of 960 is above the median of 158 across 207 observational studies indexed under Breast Feeding.

Browse Breast Feeding studies →

Lead sponsor

Centre Hospitalier de Cayenne is the lead sponsor of 47 studies on the registry; 9 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
Female
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Women who gave birth at the French Guiana University Hospital Center

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
960 participants (estimated)
Patient registry
No

Groups and cohorts

  • exposed group

    women who received health mediation services

    Other: postpartum breastfeeding support from a health mediator

  • control group

    women who did not receive health mediation services

    Other: routine health care without health mediation

Interventions

  • Otherpostpartum breastfeeding support from a health mediator

    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.

  • Otherroutine health care without health mediation

    routine health care for postpartum breastfeeding

06

What researchers measure

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).

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

    Time frame: 1 month

Secondary outcomes

  1. Rate of exclusive breastfeeding

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

    Time frame: 1 month; 3 months

  2. Duration of exclusive breasfeeding

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

    Time frame: 1 month; 3 months

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

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

    Time frame: At enrollment

  4. Level of satisfaction within the maternity ward

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

    Time frame: At enrollment

  5. Level of support for breastfeeding

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

    Time frame: At enrollment

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

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

    Time frame: 1 month; 3 months

  7. "Self-efficacy" in relation to breastfeeding

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

    Time frame: 1 month

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

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

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

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

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

    Time frame: 12 months

  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

    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

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

07

Study locations

1 of 1 sites recruiting
08

References and documents

Publications

  • Basu S, Meghani A, Siddiqi A. Evaluating the Health Impact of Large-Scale Public Policy Changes: Classical and Novel Approaches. Annu Rev Public Health. 2017 Mar 20;38:351-370. doi: 10.1146/annurev-publhealth-031816-044208. PubMed 28384086 ↗
  • Dennis CL, McQueen K, Dol J, Brown H, Beck C, Shorey S. Psychometrics of the breastfeeding self-efficacy scale and short form: a systematic review. BMC Public Health. 2024 Feb 29;24(1):637. doi: 10.1186/s12889-024-17805-6. PubMed 38419045 ↗
  • Pugh LC, Serwint JR, Frick KD, Nanda JP, Sharps PW, Spatz DL, Milligan RA. A randomized controlled community-based trial to improve breastfeeding rates among urban low-income mothers. Acad Pediatr. 2010 Jan-Feb;10(1):14-20. doi: 10.1016/j.acap.2009.07.005. Epub 2009 Oct 23. PubMed 19854119 ↗
  • Chapman DJ, Morel K, Anderson AK, Damio G, Perez-Escamilla R. Breastfeeding peer counseling: from efficacy through scale-up. J Hum Lact. 2010 Aug;26(3):314-26. doi: 10.1177/0890334410369481. PubMed 20715336 ↗
  • McLeish J, Redshaw M. Peer support during pregnancy and early parenthood: a qualitative study of models and perceptions. BMC Pregnancy Childbirth. 2015 Oct 12;15:257. doi: 10.1186/s12884-015-0685-y. PubMed 26459281 ↗
  • Basurko C, Lyonnais E, Proquot M, Forsans G, Hcini N, Camara N, Galindo MS, Gatti C, Adenis A; NPTM study team; Nacher M, Savy M. Prevalence and risk factors of food insecurity during pregnancy: a multicenter survey in French Guiana. BMC Public Health. 2025 May 23;25(1):1910. doi: 10.1186/s12889-025-23173-6. PubMed 40410770 ↗
  • Suri S, Verlato G, Ray S. Editorial: The first 1000 days: window of opportunity for child health and development. Front Nutr. 2025 Aug 18;12:1673003. doi: 10.3389/fnut.2025.1673003. eCollection 2025. No abstract available. PubMed 40901286 ↗
  • Duijts L, Jaddoe VW, Hofman A, Moll HA. Prolonged and exclusive breastfeeding reduces the risk of infectious diseases in infancy. Pediatrics. 2010 Jul;126(1):e18-25. doi: 10.1542/peds.2008-3256. Epub 2010 Jun 21. PubMed 20566605 ↗
  • Victora CG, Bahl R, Barros AJ, Franca GV, Horton S, Krasevec J, Murch S, Sankar MJ, Walker N, Rollins NC; Lancet Breastfeeding Series Group. Breastfeeding in the 21st century: epidemiology, mechanisms, and lifelong effect. Lancet. 2016 Jan 30;387(10017):475-90. doi: 10.1016/S0140-6736(15)01024-7. PubMed 26869575 ↗
  • Gavine A, Shinwell SC, Buchanan P, Farre A, Wade A, Lynn F, Marshall J, Cumming SE, Dare S, McFadden A. Support for healthy breastfeeding mothers with healthy term babies. Cochrane Database Syst Rev. 2022 Oct 25;10(10):CD001141. doi: 10.1002/14651858.CD001141.pub6. PubMed 36282618 ↗

Related links

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started May 2026 (actual). Primary completion is estimated for May 2029, 36 months after the start.

Of 86 non-industry observational studies under Breast Feeding, half reached primary completion within 31 months of starting (the median), counting those still running; a quarter within 19 and three quarters within 54. This study's planned 36 months is above that.

Counting every sponsor, half of 96 studies reached it within 33 months; a quarter within 19 and three quarters within 73.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 2, 2026
First posted
Sep 8, 2026
StartActual
May 26, 2026
Primary completionEst.
May 31, 2029
CompletionEst.
May 31, 2029
Last update
Sep 8, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 8, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07806942
Lead sponsor
Centre Hospitalier de Cayenne
Responsible party
Sponsor
First posted
Sep 8, 2026
Start date
May 26, 2026
Primary completion
May 31, 2029 (estimated)
Completion
May 31, 2029 (estimated)
Last update
Sep 8, 2026

Study contacts

Célia BASURKO, MD
Contact
celia.basurko@ch-cayenne.fr
+594594395050
Célia BASURKO, MD
study director · Centre Hospitalier de Cayenne

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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