The Effect of Gravity on the Occurrence of Lactational Mastitis

NCT05207241 | Unknown DMC

• 1 other identifier: Shengjing-LJY05
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Lactation Mastitis

Keywords

Lactation breastfeeding position; mastitis; gravity; breastfeeding position

Outcome Measures

Primary Outcomes (1)

• The occurrence of lactational mastitis during breastfeeding

  The incidence of lactational mastitis is defined as the proportion of breastfeeding mastitis that occurs during the period between the first breastfeeding and 6 months post-partum.

  Six months

Secondary Outcomes (1)

• Breast swelling and pain

  Six months

Study Arms (1)

Control group

Under the professional guidance of doctors, participating women (1) breastfeed individually without using a breast pump; (2) massage their breasts 4 times a day for 15 minutes each time; (3) breastfeeding time is scientifically matched with infant's schedule; (4) alternative breastfeed, ensuring emptying one breast within 24 hours. Doctors follow up once a month via WeChat. Participants complete the questionnaires. A breast ultrasound will be performed every three months. The infant weight will be measured and recorded 6 months after breastfeeding

Other: provides guidance on gravitationally assisted breastfeeding

Interventions

provides guidance on gravitationally assisted breastfeeding OTHER

Prior to the first breastfeeding after delivery, the guidance of gravitationally assisted breastfeeding will be provided. The primary breastfeeding position is advised to be the sitting position, supplemented by the lateral position with a time ratio of 4:1. The following guidance will also be given: (1) participating women breastfeed individually without using a breast pump; (2) massage their breasts 4 times a day for 15 minutes each time; (3) breastfeeding time is scientifically matched with infant's schedule; (4) alternative breastfeed, ensuring emptying one breast within 24 hours. Doctors follow up once a month via WeChat. Participants complete the questionnaires. A breast ultrasound will be performed every three months. The infant weight will be measured and recorded 6 months after breastfeeding.

Control group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

* primparious women; * full-term delivery; * age ≤35; * breastfeeding within 7 days after delivery; * with autonomous behavior ability; * provide voluntary informed consent; * ability to breastfeed individually; * prenatal breast ultrasound shows no breast lesions.

You may qualify if:

• primparious women;
• full-term delivery;
• age ≤35;
• breastfeeding within 7 days after delivery;
• with autonomous behavior ability;
• provide voluntary informed consent; • ability to breastfeed individually;
• prenatal breast ultrasound shows no breast lesions.

You may not qualify if:

• abnormal breast or nipple development (Poland syndrome or degree II and above inverted nipple);
• istory of breast surgery;
• history of chest radiotherapy;
• history of malignant tumors;
• history of mastitis;
• severe cardiovascular and cerebrovascular diseases, chronic diseases (Ecog score \>3, long-term medication affects breastfeeding);
• skin diseases or connective tissue diseases;
• Hepatitis, syphilis, gonorrhea, AIDS and other infectious diseases.

Sponsors & Collaborators

• Shengjing Hospital: lead

Study Sites (1)

Cancer Hospital of China Medical University, Liaoning Cancer Hospital and Institute

Shenyang, Liaoning, 110042, China

RECRUITING

MeSH Terms

Conditions

Mastitis

Condition Hierarchy (Ancestors)

Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Jianyi Li, Master

  Cancer Hospital of China Medical University, Liaoning Cancer Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jianyi Li, Master

CONTACT

8618940257177; sjbreast@yeah.net

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 21, 2021
• First Posted: January 26, 2022
• Study Start: January 1, 2022
• Primary Completion: January 31, 2023
• Study Completion: January 31, 2024
• Last Updated: January 26, 2022

Record last verified: 2022-01

Locations

CN (1)