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Completed

NCT Number: NCT05185323

Painful Breastfeeding and Osteopathic Treatment on the Mother-newborn Dyad

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

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Key information

Age range

3 day and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Bordeaux

Bordeaux, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Breastfeeding usual known aids and osteopathic treatment

Other

Breastfeeding usual known aids and osteopathic treatment

Breastfeeding usual known aids

Other

Breastfeeding usual known aids

Primary outcomes

  1. Proportion of women still breastfeeding

    Time frame: 1 month after birth

    Proportion of women still breastfeeding even if not exclusive

Secondary outcomes

  1. Pain during lactation

    Time frame: 7 days, 1 month

    Pain at each breast during lactation after osteopathic treatment (analogic visual evaluation from 0-no pain to 10-extreme pain)

  2. breastfeeding

    Time frame: 7 days, 1 month

    Proportion of women still breastfeeding even if not exclusive

  3. Proportion of women still exclusive breastfeeding

    Time frame: 1 month

    Proportion of women still exclusive breastfeeding

  4. Amount of artificial milk given per day

    Time frame: 1 month

    Amount of artificial milk given per day

Sponsors and collaborators

Lead sponsor

University Hospital, Bordeaux

Other

Registry information

Official study 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

Acronym: AMATOSTEO

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Jan 11, 2022
Registry last updated
May 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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