Actively Recruiting
Optimizing Sleep, Maternal-Offspring Bonding, and Sleep in the Maternity Ward
Led by Centre Hospitalier Universitaire, Amiens · Updated on 2026-04-13
132
Participants Needed
1
Research Sites
25 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating how using a co-sleeping crib compared to a standard crib affects sleep quality and bonding between mothers and their newborns in maternity wards. This observational, randomized, controlled study includes adult mothers who are breastfeeding and hospitalized after full-term delivery. The aim is to understand if co-sleeping improves sleep for both mother and infant and enhances their bonding while reducing maternal stress. Participants are randomly assigned to either a co-sleeping crib group or a standard crib group during their stay in the maternity ward. Mothers and newborns will wear actimeters, which are wrist and ankle bracelets respectively, to non-invasively record sleep data from the start of use until discharge (around 3 days). Mothers will also complete questionnaires assessing anxiety, stress, sleep quality, postpartum depression risk, and bonding with their infant. During the study, researchers will collect sleep measurements, maternal stress levels, and bonding evaluations using both the actimeters and validated questionnaires. The main outcome is the total sleep time over 4 months. Additional outcomes include newborn sleep quality, correlations between temperature and sleep, effects on breastfeeding duration, and any sleep pattern changes or breastfeeding complications. The study runs through August 2027, with close monitoring during the maternity stay and follow-up assessments over 4 months.
CONDITIONS
Brief Title
Optimizing Sleep Maternal-Offspring Bonding and Sleep in the Maternity Ward
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Mother over 18 years of age
- Planned vaginal delivery
- Exclusive breastfeeding chosen by the mother
- Single pregnancy
- No history of sleep disorders
- Mother able to understand, read, and speak French or has immediate support who can
- Mother affiliated to the social security system
- Signed consent to participate
- Newborn born at term (≥ 37 weeks of gestation)
You will not qualify if you...
- Scheduled cesarean section for the mother
- Mother under legal protection
- Acute or chronic unstable medical condition in the mother
- History of sleep disorders in the mother
- Mother exposed to substances that can alter sleep (alcohol, sedative drugs)
- Emergency cesarean section delivery
- Major post-partum medical complication requiring care outside maternity unit
- Newborn with major medical complication requiring care outside maternity unit
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 3 days ± 2 days
Participants are randomized to use either a standard cradle or a co-sleeping cradle. Mothers and their newborns wear actimeters to record sleep quality during their stay in the maternity ward.
1 stay in the maternity ward
Duration - 3 days ± 2 days
During their stay, mothers complete questionnaires assessing anxiety and parenting skills as part of routine care.
Questionnaires completed during the maternity ward stay
Duration - 4 months
Participants’ sleep outcomes and related measures are observed and analyzed for up to 4 months after discharge.
No specific visits; data collected remotely via actimeters and questionnaires
Trial Site Locations
Total: 1 location
1
CHU Amiens Picardie
Amiens, Picardie, France, 80054
Actively Recruiting
Research Team
P
Pierre TOURNEUX, Pr
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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