nipple fissure and nipple pain in breastfeeding women
Conditions
Interventions
experimental group:mupirocin plus aFGF
control group:mupirocin plus aFGF placebo
Sponsors
Tianjin Central Hospital of Gynecology Obstetrics
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Lactating women aged 18 and beyond; 2. Giving birth to their first baby; 3. Two weeks and longer postpartum; 4. Presenting macroscopically detectable nipple trauma or complaining of perceived nipple pain; 5. Full-term pregnancy; 6. Exclusive breastfeeding; 7. No current use of soother and milk bottle for the baby, and nipple protectors for the mother; 8. Voluntarily giving informed consent.
Exclusion criteria
Exclusion criteria: 1. Women with diagnosed chronic diseases including diabetes, mental disorders, autoimmune diseases and severe anemia; 2. Women suffering from diseases or conditions affecting breastfeeding, including infectious mastitis, ductal infections, flat or depressed nipples, nipple or subareolar abscess, and fungal infection on breast; 3. Previous use of pharmacotherapy for nipple fissure and pain; 4. Allergy to aFGF or mupirocin (At screening, an investigator will perform a skin allergy test by applying the investigational drugs on the forearm of the patient and ask her to observe and report any response within the following 24 hours. Allergy to the investigational drugs will be detected in the presence of allergic reactions); 5. Infants suffering from tongue or tooth disorders.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| visual analogue scale; | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to complete nipple pain relief;Changes in the Nipple Trauma Score;Time to complete healing of nipple trauma;MAPP-QOL; | — |
Countries
China
Contacts
Public ContactXiaofang Lv
Tianjin Central Hospital of Gynecology Obstetrics
Outcome results
None listed