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Breastfeeding Success With the Use of the WHO Syringe Technique for Management of Inverted Nipples in Lactating Women

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03529630
Enrollment
54
Registered
2018-05-18
Start date
2018-06-01
Completion date
2020-07-15
Last updated
2022-03-02

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

Conditions

Breastfeeding, Inverted Nipple

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.

Interventions

OTHERInverted syringe

Application of mild suction over the mother's inverted nipple using an inverted syringe before each breastfeeding.

Sponsors

American University of Beirut Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
One month exclusive breastfeeding rate1 month postpartumProportion of mothers who are exclusively breastfeeding

Secondary

MeasureTime frameDescription
Breastfeeding-associated complications1 week postpartumRate of breastfeeding-associated complications such as sore nipple, mastitis, pain, bleeding, breast engorgement
3-month exclusive breastfeeding rate3 months postpartumProportion of mothers who are exclusively breastfeeding
6-month exclusive breastfeeding rate6 months postpartumProportion of mothers who are exclusively breastfeeding
Nipple eversion rate1 month postpartumProportion of mothers with everted nipples
6-month mixed feeding rate6 months postpartumProportion of infants on mixed feeding
1-month mixed feeding rate1 month postpartumProportion of infants on mixed feeding
3-month mixed feeding rate3 months postpartumProportion of infants on mixed feeding
Maternal satisfaction with breastfeeding1 week postpartumMaternal satisfaction with breastfeeding assessed with the validated Maternal Breastfeeding Evaluation Scale (MBFES). The scale measures the overall maternal perceived quality with the breastfeeding experience. The scale has a Cronbach's alpha of 0.93. It is composed of 3 subscales: maternal enjoyment/role attainment, infant satisfaction/growth and lifestyle/body image. The corresponding Cronbach's alphas of the subscales are 0.93, 0.88 and 0.80 respectively. The overall score may range from 30 (least satisfied) to 150 (most satisfied).
Maternal quality of life1 month postpartumMaternal quality of life assessed with the validated Postpartum Quality of Life instrument
Successful latching1 month postpartumProportion of infants with successful latching while breastfeeding

Countries

Lebanon

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 1, 2026