Painful Breastfeeding and Osteopathic Treatment on the Mother-newborn Dyad

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Painful Breastfeeding

Intervention / Treatment
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* Other: Breastfeeding usual known aids and osteopathic treatment
* Other: Breastfeeding usual known aids


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 3 Days

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Breastfeeding usual known aids and osteopathic treatment<br>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 | Other: Breastfeeding usual known aids and osteopathic treatment<br>* Breastfeeding usual known aids and osteopathic treatment<br>|
| Active Comparator: Breastfeeding usual known aids<br>Breastfeeding usual known aids in usual care | Other: Breastfeeding usual known aids<br>* Breastfeeding usual known aids<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of women still breastfeeding | Proportion of women still breastfeeding even if not exclusive | 1 month after birth | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain during lactation | Pain at each breast during lactation after osteopathic treatment (analogic visual evaluation from 0-no pain to 10-extreme pain) | 7 days, 1 month | 
| breastfeeding | Proportion of women still breastfeeding even if not exclusive | 7 days, 1 month | 
| Proportion of women still exclusive breastfeeding | Proportion of women still exclusive breastfeeding | 1 month | 
| Amount of artificial milk given per day | Amount of artificial milk given per day | 1 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Osteopathic manipulative treatment, pain, breastfeeding