Lactation MastitisNCT05207241
The Effect of Gravity on the Occurrence of Lactational Mastitis
An observational study of Lactation Mastitis, run by Shengjing Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Lactation Mastitis
- What is being tested?
- provides guidance on gravitationally assisted breastfeeding
- How many people
- 2,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2022to 31 Jan 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Cancer Hospital of China Medical University, Liaoning Cancer Hospital and Institute
Shenyang, Liaoning, 110042
Jianyi Li, Dr., 13390127607, sjbreast@yeah.net
About this study
Official title: The Guidance on the Gravitationally Assisted Lactation Influences the Occurrence of Lactational Mastitis: a Clinical Cohort Study
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.
Read the detailed description
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.
- Conditions
- Lactation Mastitis
- Being tested
- provides guidance on gravitationally assisted breastfeeding
- Keywords
- Lactation breastfeeding position, mastitis, gravity, breastfeeding position
- Medical subject headings
- Mastitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
provides guidance on gravitationally assisted breastfeedingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: provides guidance on gravitationally assisted breastfeeding |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Six months
Secondary outcomes (1)
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.
Measured: Six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2022
- Study start1 Jan 2022
- Primary completion31 Jan 2023 (estimated)
- Study completion31 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lactation MastitisStudies of the same condition, open and under way.
- More trials run by Shengjing HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shengjing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jianyi Li, Shengjing Hospital
- Investigators
- Jianyi Li, Master, Principal investigator, Cancer Hospital of China Medical University, Liaoning Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05207241
- Sponsor's protocol ID
- Shengjing-LJY05
- Status last verified
- Jan 2022
- First submitted
- 21 Dec 2021
- Last updated
- 26 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Guidance on the Gravitationally Assisted Lactation Influences the Occurrence of Lactational Mastitis: a Clinical Cohort Study
- ClinicalTrials.gov ID
- NCT05207241
- Acronym / sponsor ID
- Shengjing-LJY05
- Conditions
- Lactation Mastitis
- Keywords
- Lactation breastfeeding position, mastitis, gravity, breastfeeding position
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Shengjing HospitalUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 31 Jan 2023 (estimated)
- Study completion
- 31 Jan 2024 (estimated)
- First posted
- 26 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Control group | – | Other: provides guidance on gravitationally assisted breastfeedingUnder 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 |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (7 listed)
- primparious women;
- full-term delivery;
- age ≤35;
- breastfeeding within 7 days after delivery;
- with autonomous behavior ability;
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| provides guidance on gravitationally assisted breastfeedingPrior 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. | Other | Control group |
Primary outcome
The occurrence of lactational mastitis during breastfeeding
Time frame: Six months
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.
1 secondary outcome
Breast swelling and pain
Time frame: Six months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jianyi Li, Master principal investigator
Cancer Hospital of China Medical University, Liaoning Cancer Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lactation Mastitis, run by Shengjing Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jianyi Li, Master (8618940257177, sjbreast@yeah.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The occurrence of lactational mastitis during breastfeeding (time frame: Six months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2022.