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New treatment option for Co-spleeping
Official title Optimizing Sleep Maternal-Offspring Bonding and Sleep in the Maternity Ward
ClinicalTrials.gov ID: NCT07525830
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- Maternal
- 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;
You likely can't join if
- 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:
See the full eligibility criteria
- Maternal
- 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
- Newborns born at term, i.e. ≥ 37+0 weeks of amenorrhea (SA).
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Amiens, Picardie, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Amiens, Picardie, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.