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

Primary Purpose

Painful Breastfeeding

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Breastfeeding usual known aids and osteopathic treatment
Breastfeeding usual known aids
Sponsored by
University Hospital, Bordeaux
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Painful Breastfeeding focused on measuring Osteopathic manipulative treatment, pain, breastfeeding

Eligibility Criteria

3 Days - undefined (Child, Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

  • CHU de BordeauxRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Breastfeeding usual known aids and osteopathic treatment

Breastfeeding usual known aids

Arm 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

Breastfeeding usual known aids in usual care

Outcomes

Primary Outcome Measures

Proportion of women still breastfeeding
Proportion of women still breastfeeding even if not exclusive

Secondary Outcome Measures

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

Full Information

First Posted
December 1, 2021
Last Updated
April 27, 2023
Sponsor
University Hospital, Bordeaux
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1. Study Identification

Unique Protocol Identification Number
NCT05185323
Brief Title
Painful Breastfeeding and Osteopathic Treatment on the Mother-newborn Dyad
Acronym
AMATOSTEO
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 23, 2022 (Actual)
Primary Completion Date
February 15, 2024 (Anticipated)
Study Completion Date
February 15, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Bordeaux

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Painful Breastfeeding
Keywords
Osteopathic manipulative treatment, pain, breastfeeding

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
168 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Breastfeeding usual known aids and osteopathic treatment
Arm Type
Experimental
Arm 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
Arm Title
Breastfeeding usual known aids
Arm Type
Active Comparator
Arm Description
Breastfeeding usual known aids in usual care
Intervention Type
Other
Intervention Name(s)
Breastfeeding usual known aids and osteopathic treatment
Intervention Description
Breastfeeding usual known aids and osteopathic treatment
Intervention Type
Other
Intervention Name(s)
Breastfeeding usual known aids
Intervention Description
Breastfeeding usual known aids
Primary Outcome Measure Information:
Title
Proportion of women still breastfeeding
Description
Proportion of women still breastfeeding even if not exclusive
Time Frame
1 month after birth
Secondary Outcome Measure Information:
Title
Pain during lactation
Description
Pain at each breast during lactation after osteopathic treatment (analogic visual evaluation from 0-no pain to 10-extreme pain)
Time Frame
7 days, 1 month
Title
breastfeeding
Description
Proportion of women still breastfeeding even if not exclusive
Time Frame
7 days, 1 month
Title
Proportion of women still exclusive breastfeeding
Description
Proportion of women still exclusive breastfeeding
Time Frame
1 month
Title
Amount of artificial milk given per day
Description
Amount of artificial milk given per day
Time Frame
1 month

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
3 Days
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Christophe Elleau, MD
Phone
+335 57 82 05 48
Email
christophe.elleau@chu-bordeaux.fr
Facility Information:
Facility Name
CHU de Bordeaux
City
Bordeaux
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christophe Ealleau, MD
Email
christophe.elleau@chu-bordeaux.fr

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Painful Breastfeeding and Osteopathic Treatment on the Mother-newborn Dyad

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