Clinical trial NCT05185323: Painful Breastfeeding and Osteopathic Treatment on the Mother-newborn Dyad
Official title: Evaluation of the Effectiveness of Osteopathic Treatment on the Mother-newborn Dyad in the Event of Painful Breastfeeding in the Maternity Hospital Despite the Application of All Usual Aids: Randomized Interventional Study in Clusters in Two Parallel Arms Without Blinding. AMATOSTEO
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Painful Breastfeeding
Keywords: Osteopathic manipulative treatment
pain
breastfeeding
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
First posted: 2022-01-11
Enrollment: 92
Sex: FEMALE
Minimum age (years): 3
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Pain during lactation is the first reason to stop breastfeeding. When usual known aids are ineffective, osteopathic treatment is a possible way to decrease the pain and improve the quality and the duration of lactation. The aim of this study is to compare usual known aids alone and usual known aids added to osteopathic treatment of the baby and the mother. The primary outcome is the lactation rate (exclusive or partial) at 1 month after birth

Detailed description: Breastfeeding is recognized to be essential for childhood health and public health. The first reason to stop breastfeeding before the second month after birth is pain during lactation. The second reason to stop breastfeeding is back-to-work, generally two months after birth. Few years ago, osteopathic treatment has been introduced at maternity hospital of Bordeaux when usual known aids are ineffective. The osteopathic treatment is completely integrated in the maternity hospital of Bordeaux but no strong evaluation is available in literature. A pilot evaluation on 27 patients showed a good effectiveness of osteopathic treatment on breastfeeding at 1 months ½ after birth (85% of patients) Breast pain decreased or disappeared after the osteopathic treatment. Another evaluation showed a small rate of lactation (15% of patients) in a non treated group at 1 month ½. In the present study, osteopathic treatment will be added to usual known aids for 40 mother-newborn dyads when pain during lactation is greater than 7 (0 to 10 scale). The experimental group will be compared with 40 "non treated" mother-newborn dyads (only usual known aids in routine care). Among other, breastfeeding and pain during lactation will be evaluated at the maternity hospital discharge and will be repeated at 1 month after birth.

Eligibility criteria: Inclusion Criteria:

* Mother 18 yrs and older who chose to breast-feed (exclusive or not)
* Singleton newborn after 37 weeks of gestation, weighing at least 2500 g at birth, after 36 hours of life
* Pain during lactation greater than 7 (scale 0 to 10) in one or both breasts
* Usual known aids ineffective to reduce pain during lactation
* Mother speaking and understanding French
* Mother affiliated or beneficiary to a health system
* Signed informed consent.

Exclusion Criteria:

* Medical contraindication to osteopathic treatment (non stabilized infection, acute neurological pathology, tumor or cancer process, maternal psychiatric disorders)
* Severe congenitale malformation, especially not allowing normal lactation
* Patient under legal protection
* Persons deprived of their liberty by judicial or administrative decision

Primary outcomes:
measure: Proportion of women still breastfeeding
timeFrame: 1 month after birth
Secondary outcomes:
measure: Pain during lactation
timeFrame: 7 days, 1 month
measure: breastfeeding
timeFrame: 7 days, 1 month
measure: Proportion of women still exclusive breastfeeding
timeFrame: 1 month
measure: Amount of artificial milk given per day
timeFrame: 1 month
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: CHU de Bordeaux
Study officials:
References: