Breastfeeding Success With the Use of the WHO Syringe Technique for Management of Inverted Nipples in Lactating Women
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|ClinicalTrials.gov Identifier: NCT03529630|
Recruitment Status : Recruiting
First Posted : May 18, 2018
Last Update Posted : June 28, 2018
|Condition or disease||Intervention/treatment||Phase|
|Breastfeeding Inverted Nipple||Other: Inverted syringe||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||June 1, 2018|
|Estimated Primary Completion Date :||May 31, 2020|
|Estimated Study Completion Date :||September 30, 2020|
Experimental: Inverted syringe
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
Application of mild suction over the mother's inverted nipple using an inverted syringe before each breastfeeding.
No Intervention: Standard of care
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. .
- One month exclusive breastfeeding rate [ Time Frame: 1 month postpartum ]Proportion of mothers who are exclusively breastfeeding
- 3-month exclusive breastfeeding rate [ Time Frame: 3 months postpartum ]Proportion of mothers who are exclusively breastfeeding
- 6-month exclusive breastfeeding rate [ Time Frame: 6 months postpartum ]Proportion of mothers who are exclusively breastfeeding
- Nipple eversion rate [ Time Frame: 1 month postpartum ]Proportion of mothers with everted nipples
- Successful latching [ Time Frame: 1 month postpartum ]Proportion of infants with successful latching while breastfeeding
- 1-month mixed feeding rate [ Time Frame: 1 month postpartum ]Proportion of infants on mixed feeding
- 3-month mixed feeding rate [ Time Frame: 3 months postpartum ]Proportion of infants on mixed feeding
- 6-month mixed feeding rate [ Time Frame: 6 months postpartum ]Proportion of infants on mixed feeding
- Breastfeeding-associated complications [ Time Frame: 1 week postpartum ]Rate of breastfeeding-associated complications such as sore nipple, mastitis, pain, bleeding, breast engorgement
- Breastfeeding-associated complications [ Time Frame: 1 month postpartum ]Rate of breastfeeding-associated complications such as sore nipple, mastitis, pain, bleeding, breast engorgement
- Breastfeeding-associated complications [ Time Frame: 3 months postpartum ]Rate of breastfeeding-associated complications such as sore nipple, mastitis, pain, bleeding, breast engorgement
- Breastfeeding-associated complications [ Time Frame: 6 months postpartum ]
- Maternal satisfaction with breastfeeding [ Time Frame: 1 week postpartum ]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).
- Maternal quality of life [ Time Frame: 1 month postpartum ]Maternal quality of life assessed with the validated Postpartum Quality of Life instrument
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03529630
|American University of Beirut Medical Center||Recruiting|
|Contact: Mona Nabulsi, MD, MS 9611350000 ext 5523 email@example.com|