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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
Sponsor:
Information provided by (Responsible Party):
Mona Nabulsi, American University of Beirut Medical Center

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.

Condition or disease Intervention/treatment Phase
Breastfeeding Inverted Nipple Other: Inverted syringe Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breastfeeding

Arm Intervention/treatment
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. .



Primary Outcome Measures :
  1. One month exclusive breastfeeding rate [ Time Frame: 1 month postpartum ]
    Proportion of mothers who are exclusively breastfeeding


Secondary Outcome Measures :
  1. 3-month exclusive breastfeeding rate [ Time Frame: 3 months postpartum ]
    Proportion of mothers who are exclusively breastfeeding

  2. 6-month exclusive breastfeeding rate [ Time Frame: 6 months postpartum ]
    Proportion of mothers who are exclusively breastfeeding

  3. Nipple eversion rate [ Time Frame: 1 month postpartum ]
    Proportion of mothers with everted nipples

  4. Successful latching [ Time Frame: 1 month postpartum ]
    Proportion of infants with successful latching while breastfeeding

  5. 1-month mixed feeding rate [ Time Frame: 1 month postpartum ]
    Proportion of infants on mixed feeding

  6. 3-month mixed feeding rate [ Time Frame: 3 months postpartum ]
    Proportion of infants on mixed feeding

  7. 6-month mixed feeding rate [ Time Frame: 6 months postpartum ]
    Proportion of infants on mixed feeding

  8. Breastfeeding-associated complications [ Time Frame: 1 week postpartum ]
    Rate of breastfeeding-associated complications such as sore nipple, mastitis, pain, bleeding, breast engorgement

  9. Breastfeeding-associated complications [ Time Frame: 1 month postpartum ]
    Rate of breastfeeding-associated complications such as sore nipple, mastitis, pain, bleeding, breast engorgement

  10. Breastfeeding-associated complications [ Time Frame: 3 months postpartum ]
    Rate of breastfeeding-associated complications such as sore nipple, mastitis, pain, bleeding, breast engorgement

  11. Breastfeeding-associated complications [ Time Frame: 6 months postpartum ]
    Rate of breastfeeding-associated complications such as sore nipple, mastitis, pain, bleeding, breast engorgement

  12. 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).

  13. Maternal quality of life [ Time Frame: 1 month postpartum ]
    Maternal quality of life assessed with the validated Postpartum Quality of Life instrument



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

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


Locations
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Lebanon
American University of Beirut Medical Center Recruiting
Beirut, Lebanon
Contact: Mona Nabulsi, MD, MS    9611350000 ext 5523    mn04@aub.edu.lb   
Sponsors and Collaborators
American University of Beirut Medical Center

Additional Information:
Publications:

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Responsible Party: Mona Nabulsi, Professor of Clinical Pediatrics, American University of Beirut Medical Center
ClinicalTrials.gov Identifier: NCT03529630     History of Changes
Other Study ID Numbers: PED.MN.15
First Posted: May 18, 2018    Key Record Dates
Last Update Posted: June 28, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Sharing of anonymized IPD is possible upon request from the principal investigator after 1 year from publication of the study.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: After December 2021.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No