Postpartum Depression Clinical Trials

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Optimizing Sleep Maternal-Offspring Bonding and Sleep in the Maternity Ward

Status: Recruiting
Location: See location...
Intervention Type: Device, Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The quality of sleep in maternity wards is crucial for the mental and physical health of the mother, as well as for the development of secure mother to infant bonding. The introduction of co-dodo cribs, although scarcely studied, may influence sleep quality in both the mother and the newborn infant. Objective : This study aims at evaluating the impact of a co-dodo crib on the sleep quality of the newborn infant, her mother and the mother-infant bonding, compared to a control group with mother using a standard crib. This observational, randomized, controlled, multicenter study will include adult mother, breastfeeding and hospitalized in maternity wards after full-term delivery (≥ 37 weeks of gestation). Participant will be randomly assigned in a 1:1 ratio to receive either a co-dodo crib or a standard crib for their newborn infant during their maternity STAI-Y. Actigraphic data will be used for non-invasive sleep assessment in both the newborn infant and the mother. Validated self-reported questionnaires will evaluate maternal stress, sleep quality, post-partum depression risk and mother-infant bonding. • Hypothesis : We hypothesize that using a co-dodo crib compared to a standard crib may improve the newborn and mother sleep quality, decrease the mother stress and enhance the mother to infant bonding.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• Maternal inclusion criteria:

• Mother over 18 years of age;

• Mother for whom vaginal delivery is planned

• Mother who has chosen to breastfeed exclusively;

• Mother who has a single pregnancy;

• Mother with no history of sleep disorders.

• Mother able to understand, read and speak French or, failing that, who has someone in her immediate circle who can understand, read and speak French;

• Mother affiliated to the social security system;

• Having signed the consent to participate in the study

• Newborn inclusion criteria:

• Newborns born at term, i.e. ≥ 37+0 weeks of amenorrhea (SA).

Locations
Other Locations
France
CHU Amiens Picardie
RECRUITING
Amiens
Contact Information
Primary
Pierre TOURNEUX, Pr
Tourneux.pierre@chu-amiens.fr
33+322088051
Time Frame
Start Date: 2026-02-16
Estimated Completion Date: 2027-08
Participants
Target number of participants: 132
Treatments
Active_comparator: standard cradle
Experimental: co-sleeping cradle
Related Therapeutic Areas
Sponsors
Leads: Centre Hospitalier Universitaire, Amiens

This content was sourced from clinicaltrials.gov