Painful Breastfeeding and Osteopathic Treatment on the Mother-newborn Dyad (AMATOSTEO)

University Hospital of Bordeaux

Status: Completed

Conditions: Painful Breastfeeding

Treatments: Other: Breastfeeding usual known aids; Other: Breastfeeding usual known aids and osteopathic treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT05185323

CHUBX 2018/38

Details and patient eligibility

About

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

Full 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.

Enrollment: 92 patients

Sex: Female

Ages: 3+ days old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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92 participants in 2 patient groups

Breastfeeding usual known aids and osteopathic treatment

Experimental group

Description:

The osteopathic treatment consists of manual listening without intention, without thrust. The hands follow the spontaneous movements of the patients. The end of the treatment is perceived by an overall relief and a feeling of balance for the baby and his mother

Treatment:

Other: Breastfeeding usual known aids and osteopathic treatment

Breastfeeding usual known aids

Active Comparator group

Description:

Breastfeeding usual known aids in usual care

Treatment:

Other: Breastfeeding usual known aids