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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Breastfeeding, Inverted Nipple

Intervention / Treatment
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* Other: Inverted syringe


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy pregnant women in their 37th week of gestation or more with grade 1 or 2 inverted nipples Able to read and write 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: Women with grade 3 inverted nipples Previous breast surgery affecting the breast anatomy High risk pregnancies Medical conditions that could interfere with breastfeeding such as critical maternal condition Newborns with congenital malformations that may interfere with breastfeeding such as esophageal atresia, cleft lip &/or palate Women choosing artificial milk as their preferred infant nutrition.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Inverted syringe<br>Participants in this arm will use of the inverted syringe before each breastfeeding starting from the first feed after delivery and continued as long as needed by the mother. | Other: Inverted syringe<br>* Application of mild suction over the mother's inverted nipple using an inverted syringe before each breastfeeding.<br>|
| No Intervention: Standard of care<br>Participants in the control group will receive standard medical care as dictated by their obstetricians. Any advice regarding infant nutrition or treatment of inverted nipples will be left to the primary physician, including possible use of the inverted syringe technique. . | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| One month exclusive breastfeeding rate | Proportion of mothers who are exclusively breastfeeding | 1 month postpartum | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 3-month exclusive breastfeeding rate | Proportion of mothers who are exclusively breastfeeding | 3 months postpartum | 
| 6-month exclusive breastfeeding rate | Proportion of mothers who are exclusively breastfeeding | 6 months postpartum | 
| Nipple eversion rate | Proportion of mothers with everted nipples | 1 month postpartum | 
| Successful latching | Proportion of infants with successful latching while breastfeeding | 1 month postpartum | 
| 1-month mixed feeding rate | Proportion of infants on mixed feeding | 1 month postpartum | 
| 3-month mixed feeding rate | Proportion of infants on mixed feeding | 3 months postpartum | 
| 6-month mixed feeding rate | Proportion of infants on mixed feeding | 6 months postpartum | 
| Breastfeeding-associated complications | Rate of breastfeeding-associated complications such as sore nipple, mastitis, pain, bleeding, breast engorgement | 1 week postpartum | 
| Breastfeeding-associated complications | Rate of breastfeeding-associated complications such as sore nipple, mastitis, pain, bleeding, breast engorgement | 1 month postpartum | 
| Breastfeeding-associated complications | Rate of breastfeeding-associated complications such as sore nipple, mastitis, pain, bleeding, breast engorgement | 3 months postpartum | 
| Breastfeeding-associated complications | Rate of breastfeeding-associated complications such as sore nipple, mastitis, pain, bleeding, breast engorgement | 6 months postpartum | 
| Maternal satisfaction with breastfeeding | Maternal 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). | 1 week postpartum | 
| Maternal quality of life | Maternal quality of life assessed with the validated Postpartum Quality of Life instrument | 1 month postpartum |