An observational study in Lactation Mastitis, sponsored by Shengjing Hospital. Status unknown at 1 site in China. Open to female participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-01-26.
Sponsored by Shengjing Hospital · Observational
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.
Time of recruitment: 1 December 2021 - 30 April 2022. Two thousand women who meet the following criteria are to be recruited:(1) primparious women; (2) full-term delivery;(3) age ≤35 (4) breastfeeding within 7 days after delivery; (5) with autonomous behavior ability; (6) provide voluntary informed consent; (7) ability to breastfeed individually(8) prenatal breast ultrasound shows no breast lesions.. Exclusive criteria: (1) abnormal breast or nipple development (Poland syndrome or degree II and above inverted nipple); (2) history of breast surgery; (3) history of chest radiotherapy; (4) history of malignant tumors; (5) History of mastitis; (6) severe cardiovascular and cerebrovascular diseases, chronic diseases (Ecog score >3, long-term medication affects breastfeeding); (7) skin diseases or connective tissue diseases; (8) Hepatitis, syphilis, gonorrhea, AIDS and other infectious diseases. Criteria of elimination after recruitment: (1) failure to follow the breastfeeding instruction; (2) painless breast mass.
Participants are to be randomly divided into the interventional group which provides guidance on gravitationally assisted breastfeeding, and into the control group which provides general breastfeeding guidance. Through the social media network WeChat, each participant receives breastfeeding guidance before their first breastfeeding, and once a month until 6 months after childbirth. Additionally, at 3 and 6 postpartum, the breasts will be examined by a breast surgeon at Shenyang Women and Infants Hospital. Infant's height and weight will be measured and recorded at 6 months. The incidence of breastfeeding mastitis and the rate of baby weight gain are compared between the groups. This clinical cohort study aims to investigate effects of scientific guidance on the gravitationally assisted breastfeeding positions on the occurrence of breast mastitis.
31 studies on the registry are indexed under Mastitis; 7 are open to participants now.
This study's planned enrollment of 2,000 is above the median of 211 across 14 observational studies indexed under Mastitis.
Browse Mastitis studies →Shengjing Hospital is the lead sponsor of 127 studies on the registry; 59 are open to participants now.
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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.
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.
Time frame: Six months
Breast swelling and pain
Mastitis is caused by the failure of milk to discharge in time, resulting in milk accumulation.Milk accumulation is a prodrome of lactational mastitis.
Time frame: Six months
This study is status unknown, as verified in Jan 2022. You cannot join it, but the record below documents what was studied.
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