Optimizing Sleep Maternal-Offspring Bonding and Sleep in the Maternity Ward
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorCentre Hospitalier Universitaire, Amiens
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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;
Disqualifiers
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;
Trial design
Design model
Parallel
Treatments tested in this trial
actimeters
DevicePatients 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.
questionnaires
Other interventionDuring their stay in the maternity unit, the mothers will complete questionnaires used in routine care to assess anxiety and parenting skills
Treatment groups
132 Participants
are divided into 2 treatment groupsGroup A: standard cradleActive comparator 2 interventions
Group B: co-sleeping cradleExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
total sleep time in both groups
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.
Time frame
4 monthsSecondary outcomes
1
total sleep time of newborn in co-sleeping group
Evaluate the effect of co-sleeping on total sleep time of newborn
Time frame
4 months2
sleep quality of newborn
sleep quality of newborn is evaluated by total sleep time
Time frame
4 months3
correlation between temperature and sleep quality
Sleep quality is evaluated with total sleep time
Time frame
4 months4
effect of co-sleeping on parental anxiety
During their stay in the maternity unit, the mothers will complete questionnaires used in routine care to assess anxiety and parenting skills.
Time frame
4 monthsSponsors and contacts
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Source ClinicalTrials.gov