Breastfeeding Success With the Use of the WHO Syringe Technique for Management of Inverted Nipples in Lactating Women
Condition: Breastfeeding; Inverted Nipple
Study type: Interventional

Summary: 
      Breastfeeding is the ideal infant nutrition recommended by governmental and medical
      professional organizations. Yet, women with inverted nipples often face difficulties in
      breastfeeding that ultimately force them to prematurely terminate breastfeeding. This
      open-label randomized clinical trial aims to investigate the effectiveness of the use of the
      inverted syringe technique on exclusive breastfeeding success in women with inverted nipples,
      as compared to standard of care.
    

Detailed description: 
      Breastfeeding is the ideal infant nutrition recommended by governmental and medical
      professional organizations. Its benefits to infants and their mothers are many including
      protection from infections, certain malignancies and chronic diseases, as well as improved
      growth, development, cognition and intelligence for children. Yet, women with inverted
      nipples often face difficulties in breastfeeding that ultimately force them to prematurely
      terminate breastfeeding. The main treatment of severely inverted nipples is surgical
      sectioning of the lactiferous ducts at the expense of breast's function. Several conservative
      measures have also been used for the less severe (grades 1 and 2) inverted nipples such as
      application of Hoffman Exercises and Woolwich Breast Shields, which have failed to prove
      their worth. The modified syringe technique is a conservative means for the correction of
      inverted nipples that was reported in a single case series of 8 women, with high success
      rates in infant latching (7/8) and exclusive breastfeeding (6/8). It is a simple,
      inexpensive, portable, safe, and easily learned method that can be performed by mothers as
      often as required.

      This open-label randomized clinical trial aims to investigate the effectiveness of the use of
      inverted syringe on the 1-month exclusive breastfeeding rate in women with inverted nipples.
      We hypothesize that in women with grades 1 and 2 inverted nipples, the use of the modified
      syringe technique soon after delivery, as opposed to the standard of care, will significantly
      improve breastfeeding rates at 1 month postpartum. We will recruit 100 healthy women at ≥37
      weeks of gestation with grades 1 or 2 inverted nipples from the Women's Health Center and the
      obstetrics outpatient department at AUBMC. They will be randomly allocated to a control group
      (standard of care) or to the intervention group (inverted syringe). Data will be collected at
      baseline (socio-demographic variables, inverted nipple grading) and at 1, 3, and 7 days
      postpartum about infant feeding method, and adverse events. Mothers will be contacted at 1, 3
      and 6 months regarding infant feeding method, maternal satisfaction, infant's weight gain and
      adverse events. The association between breastfeeding success at 1 month and the use of the
      inverted syringe will be investigated using multivariate regression models. Findings from
      this study, if positive, will provide much needed evidence for a safe, affordable, readily
      available and simple intervention to treat inverted nipples and improve breastfeeding
      practice among affected women.
    

Intervention name(s): Inverted syringe
Intervention type(s): Other
Intervention description(s): Application of mild suction over the mother's inverted nipple using an inverted syringe before each breastfeeding.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment