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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

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

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2005-002325-31-GB
Enrollment
200
Registered
2005-06-30
Start date
2005-11-04
Completion date
Unknown
Last updated
2020-07-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nipple pain in breastfeeding women

Interventions

Trade Name: Nystan cream Product Name: Nystan cream Pharmaceutical Form: Cream INN or Proposed INN: nystatin Other descriptive name: aluminiumhydroxide, benzyl alcohol, macrogol ether, propylene glyco

Sponsors

Taunton & Somerset NHS Trust
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
Main Objective: Main aim: To establish in the first 14 days after birth, which of three topical treatments is most clinically and cost-effective compared to the standard of expressed breast milk at prolonging breastfeeding by preventing or treating nipple pain and trauma. Objectives : (1) to prolong breastfeeding to 42 days (POM) (2) to prevent/treat nipple pain up to 14 days (SOM) ;Secondary Objective: ;Primary end point(s): Any breastfeeding at six weeks of age (ascertained by telephone)—

Countries

United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026