Clinical Trials Directory

Trials / Completed

CompletedNCT05185323

Painful Breastfeeding and Osteopathic Treatment on the Mother-newborn Dyad

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
92 (actual)
Sponsor
University Hospital, Bordeaux · Academic / Other
Sex
Female
Age
3 Days
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
OTHERBreastfeeding usual known aids and osteopathic treatmentBreastfeeding usual known aids and osteopathic treatment
OTHERBreastfeeding usual known aidsBreastfeeding usual known aids

Timeline

Start date
2022-03-23
Primary completion
2024-04-12
Completion
2024-04-12
First posted
2022-01-11
Last updated
2024-05-17

Locations

1 site across 1 country: France

Source: ClinicalTrials.gov record NCT05185323. Inclusion in this directory is not an endorsement.