Clinical trial NCT03529630: Breastfeeding Success With the Use of the WHO Syringe Technique for Management of Inverted Nipples in Lactating Women
Official title: Breastfeeding Success With the Use of the WHO Syringe Technique for Management of Inverted Nipples in Lactating Women: a Study Protocol for a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breastfeeding
Inverted Nipple
Lead sponsor: American University of Beirut Medical Center
Sponsor class: OTHER
First posted: 2018-05-18
Enrollment: 54
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

1. Healthy pregnant women in their 37th week of gestation or more with grade 1 or 2 inverted nipples
2. Able to read and write
3. Singleton or twin pregnancy An inverted nipple is defined as a condition in which the nipple is pulled inward into the breast instead of pointing outward, classified according to Han and Hong \[11\].

Exclusion Criteria:

1. Women with grade 3 inverted nipples
2. Previous breast surgery affecting the breast anatomy
3. High risk pregnancies
4. Medical conditions that could interfere with breastfeeding such as critical maternal condition
5. Newborns with congenital malformations that may interfere with breastfeeding such as esophageal atresia, cleft lip \&/or palate
6. Women choosing artificial milk as their preferred infant nutrition.

Primary outcomes:
measure: One month exclusive breastfeeding rate
timeFrame: 1 month postpartum
Secondary outcomes:
measure: 3-month exclusive breastfeeding rate
timeFrame: 3 months postpartum
measure: 6-month exclusive breastfeeding rate
timeFrame: 6 months postpartum
measure: Nipple eversion rate
timeFrame: 1 month postpartum
measure: Successful latching
timeFrame: 1 month postpartum
measure: 1-month mixed feeding rate
timeFrame: 1 month postpartum
measure: 3-month mixed feeding rate
timeFrame: 3 months postpartum
measure: 6-month mixed feeding rate
timeFrame: 6 months postpartum
measure: Breastfeeding-associated complications
timeFrame: 1 week postpartum
measure: Breastfeeding-associated complications
timeFrame: 1 month postpartum
measure: Breastfeeding-associated complications
timeFrame: 3 months postpartum
measure: Breastfeeding-associated complications
timeFrame: 6 months postpartum
measure: Maternal satisfaction with breastfeeding
timeFrame: 1 week postpartum
measure: Maternal quality of life
timeFrame: 1 month postpartum
Other outcomes:
Locations:
city: Beirut
country: Lebanon
facility: American University of Beirut Medical Center
Study officials:
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