Optimizing Sleep Maternal-Offspring Bonding and Sleep in the Maternity Ward (NCT07525830) | Clinical Trial Compass
RecruitingNot Applicable
Optimizing Sleep Maternal-Offspring Bonding and Sleep in the Maternity Ward
France132 participantsStarted 2026-02-16
Plain-language 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.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.