Two parallel trials to compare the effectiveness, and potential adverse side-effects, of four routinely used topical therapies to prolong breastfeeding, by either (1) preventing or (2) treating nipple pain and trauma. - Topical treatment of nipple pain in breastfeeding
Phase 1
- Conditions
- ipple pain in breastfeeding women
- Registration Number
- EUCTR2005-002325-31-GB
- Lead Sponsor
- Taunton & Somerset NHS Trust
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 200
Inclusion Criteria
provide informed written consent; attempt at least one breastfeed; no artificial feeding prior to recruitment; aged 16+.
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
Multiple birth, baby admitted to SCBU, serious congenital abnormalities affecting ability to suckle, preterm delivery; serious maternal illness or drug treatment that may affect pain perception or wound healing.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method