Skip to content

Painful Breastfeeding and Osteopathic Treatment on the Mother-newborn Dyad

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05185323
Acronym
AMATOSTEO
Enrollment
92
Registered
2022-01-11
Start date
2022-03-23
Completion date
2024-04-12
Last updated
2024-05-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Painful Breastfeeding

Keywords

Osteopathic manipulative treatment, pain, breastfeeding

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.

Interventions

OTHERBreastfeeding usual known aids and osteopathic treatment

Breastfeeding usual known aids and osteopathic treatment

OTHERBreastfeeding usual known aids

Breastfeeding usual known aids

Sponsors

University Hospital, Bordeaux
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
3 Days to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Proportion of women still breastfeeding1 month after birthProportion of women still breastfeeding even if not exclusive

Secondary

MeasureTime frameDescription
Pain during lactation7 days, 1 monthPain at each breast during lactation after osteopathic treatment (analogic visual evaluation from 0-no pain to 10-extreme pain)
breastfeeding7 days, 1 monthProportion of women still breastfeeding even if not exclusive
Proportion of women still exclusive breastfeeding1 monthProportion of women still exclusive breastfeeding
Amount of artificial milk given per day1 monthAmount of artificial milk given per day

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026