Optimizing Sleep Maternal-Offspring Bonding and Sleep in the Maternity Ward
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 132
- Locations
- 1
- Primary Endpoint
- total sleep time in both groups
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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).
Exclusion Criteria
- •Non-inclusion criterion relating to the mother:
- •Mother for whom a cesarean section is scheduled
- •Mother under legal protection ;
- •Mother presenting with an acute or chronic non-stabilized condition;
- •Mother with a history of sleep disorders;
- •Mother exposed to substances that can alter sleep (alcohol, sedative drugs).
- •Secondary exclusion criteria:
- •Mother who gave birth by emergency cesarean section
- •Mother with a major post-partum medical complication requiring follow-up in a unit other than the maternity unit;
- •Newborn with a major medical complication requiring follow-up in a unit other than the maternity unit.
Arms & Interventions
standard cradle
Intervention: actimeters (Device)
standard cradle
Intervention: questionnaires (Other)
co-sleeping cradle
Intervention: actimeters (Device)
co-sleeping cradle
Intervention: questionnaires (Other)
Outcomes
Primary Outcomes
total sleep time in both groups
Time Frame: 4 months
impact of co-sleeping on the total sleep time of breastfeeding mothers, compared with a control group in which the breastfeeding mothers use a standard cradle.
Secondary Outcomes
- total sleep time of newborn in co-sleeping group(4 months)
- sleep quality of newborn(4 months)
- correlation between temperature and sleep quality(4 months)
- effect of co-sleeping on parental anxiety(4 months)
- correlation between sleeping arrangements and continued breastfeeding duration(4 months)
- Number of newborns with sleeping pattern modifications(4 months)
- Number of mothers with modified quality of sleep(4 months)
- complications related to breastfeeding(4 months)
- sleep quality of breastfeeding mother(4 months)