NCT05207241

The Effect of Gravity on the Occurrence of Lactational Mastitis

Status unknown Last updated 26 January 2022

What this trial tests

trial testing provides guidance on gravitationally assisted breastfeeding in Lactation Mastitis in 2,000 participants. Status unknown.

Timeline

1 January 2022

Primary endpoint
31 January 2023

31 January 2024

Quick facts

Lead sponsor	Shengjing Hospital
Status	Status unknown
Study type	OBSERVATIONAL
Enrollment	2,000
Start date	1 January 2022
Primary completion	31 January 2023
Estimated completion	31 January 2024
Sites	1 location across China

Drugs / interventions tested

• provides guidance on gravitationally assisted breastfeeding

Conditions studied

• Lactation Mastitis — all drugs for Lactation Mastitis →

Sponsor

Shengjing Hospital

Who can join

Adults 18 to 50, female only, with Lactation Mastitis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Lactation is the instinct of almost all mammals, including human beings. With the development of human society, the function of lactation has gradually deviated from nature instinct. Breastfeeding related industries, such as milk bottles, formula and breast pumps, have formed a vast consumer market, leading to a transition from breastfeeding mothers' individual instinct to the social division of labor. Previous studies found that the incidence of lactational mastitis remains largely unchanged post World War II with some reporting an increase, suggesting the hazards of lactational mastitis still exist under the background of social division of labor. Breast milk contains ingredients that improve the immunity of newborns. By affecting mothers' breastfeeding, lactational mastitis pose a hazard for newborns, increasing the chances of developing respiratory and gastrointestinal diseases. For breastfeeding mothers, severe mastitis may develop into breast abscess due to improper treatment in the early stage. In addition to antibiotic treatment, incision, drainage and even surgery may be required. These potentially increase the risk of developing postpartum depression, type II diabetes, breast cancer and ovarian cancer. Compared with other mammals, humans and cows have a higher incidence of lactational mastitis, indicating that human intervention in breastfeeding may be the cause of the high incidence. On the other hand, as a result of walking upright, humans' hands are liberated, forming complex and diverse breastfeeding position. According to the Sakra World Hospital, these positions are classified into eight types: cradle, cross cradle, supine, football, Australian hold, inverted lateral, lateral cradle, and lateral. The pilot study demonstrated that different breastfeeding positions are closed related to the occurrence of lactational mastitis, and to the location of mastitis. Assuming that the baby's sucking factors remain the same, there must be differences in the milk drainage in different breastfeeding positions under the influence of gravity. Researchist speculate that breastfeeding women who opt to a position that cause an anti-gravitational expulsion of milk are more likely to develop lactational mastitis. Therefore, this study aims to investigate how the scientific guidance on the gravitationally assisted breastfeeding positions will reduce the occurrence of mastitis.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.