Actively Recruiting

Phase Not Applicable
Age: 18Years +
FEMALE
NCT07525830

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

75 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Optimizing Sleep Maternal-Offspring Bonding and Sleep in the Maternity Ward

Who Can Participate

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

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
  • Ability to understand, read, and speak French or having someone close who can
  • Affiliated with the social security system
  • Signed consent to participate
  • Newborn born at term (at least 37 weeks of gestation)
Not Eligible

You will not qualify if you...

  • Scheduled cesarean section for the mother
  • Mother under legal protection
  • Mother with acute or chronic non-stabilized condition
  • History of sleep disorders in the mother
  • Mother exposed to substances affecting sleep (alcohol, sedative drugs)
  • Emergency cesarean section delivery
  • Major postpartum medical complications requiring care outside the maternity unit
  • Newborn with major medical complications requiring care outside the maternity unit

AI-Screening

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Trial Site Locations

Total: 1 location

1

CHU Amiens Picardie

Amiens, Picardie, France, 80054

Actively Recruiting

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Research Team

P

Pierre TOURNEUX, Pr

CONTACT

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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