Painful Breastfeeding and Osteopathic Treatment on the Mother-newborn Dyad

Not Applicable

Completed

• Conditions: Painful Breastfeeding

• Registration Number: NCT05185323
• Lead Sponsor: University Hospital, Bordeaux

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.

Study Timeline

• Study First Submitted: 2021-12-01
• Study First Submitted QC: 2022-01-07
• Study First Posted: 2022-01-11
• Study Start: 2022-03-23
• Primary Completion: 2024-04-12
• Study Completion: 2024-04-12
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-16
• Last Update Posted: 2024-05-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 92

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Proportion of women still breastfeeding	1 month after birth	Proportion of women still breastfeeding even if not exclusive

Secondary Outcome Measures

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

Trial Locations

Locations (1)

CHU de Bordeaux; 🇫🇷 Bordeaux, France