NCT07525830

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 132 (estimated)
• Sponsor: Centre Hospitalier Universitaire, Amiens · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Co-spleeping
• Spleeping Quality
• Newborn
• Breastfeeding Mothers
• Bonding

Interventions

Type	Name	Description
DEVICE	actimeters	Patients and their newborns will be randomized into two groups: standard cradle or co-sleeping cradle. Once the cradle has been allocated, they will be given two actimeters: one for the mother (a bracelet worn on the wrist) and a second for the newborn (a bracelet worn on the ankle above the pyjamas). Recording of sleep quality data will begin as soon as the actimeters are worn. At the end of their stay in the maternity ward (3 days ± 2 days), the actimeters will be returned to us and the data downloaded into the dedicated software.
OTHER	questionnaires	During their stay in the maternity unit, the mothers will complete questionnaires used in routine care to assess anxiety and parenting skills

Timeline

• Start date: 2026-02-16
• Primary completion: 2027-02-01
• Completion: 2027-08-01
• First posted: 2026-04-13
• Last updated: 2026-04-13

Locations

1 site across 1 country: France