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

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

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

Study Overview

• Status: Recruiting
• Conditions: Painful Breastfeeding
• Intervention / Treatment: Other: Breastfeeding usual known aids and osteopathic treatment; Other: Breastfeeding usual known aids

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 Type: Interventional
• Enrollment (Anticipated): 168
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Christophe Elleau, MD; Phone Number: +335 57 82 05 48; Email: christophe.elleau@chu-bordeaux.fr

Study Locations

• France
  • Bordeaux, France
    • Recruiting
    • CHU de Bordeaux
    • Contact: Christophe Ealleau, MD; Email: christophe.elleau@chu-bordeaux.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 days and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Breastfeeding usual known aids and osteopathic treatment; 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; Breastfeeding usual known aids and osteopathic treatment
Active Comparator: Breastfeeding usual known aids; Breastfeeding usual known aids in usual care	Other: Breastfeeding usual known aids; Breastfeeding usual known aids

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University Hospital, Bordeaux

Study record dates

Study Major Dates

• Study Start (Actual): March 23, 2022
• Primary Completion (Anticipated): February 15, 2024
• Study Completion (Anticipated): February 15, 2024

Study Registration Dates

• First Submitted: December 1, 2021
• First Submitted That Met QC Criteria: January 7, 2022
• First Posted (Actual): January 11, 2022

Study Record Updates

• Last Update Posted (Actual): April 28, 2023
• Last Update Submitted That Met QC Criteria: April 27, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: pain; breastfeeding; Osteopathic manipulative treatment
• Additional Relevant MeSH Terms: Neurologic Manifestations; Pain
• Other Study ID Numbers: CHUBX 2018/38

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No