Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03529630
Recruitment Status : Recruiting
First Posted : May 18, 2018
Last Update Posted : July 23, 2020
Sponsor:
Information provided by (Responsible Party):
Mona Nabulsi, American University of Beirut Medical Center

Tracking Information
First Submitted Date  ICMJE May 8, 2018
First Posted Date  ICMJE May 18, 2018
Last Update Posted Date July 23, 2020
Actual Study Start Date  ICMJE June 1, 2018
Estimated Primary Completion Date May 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 8, 2018)
One month exclusive breastfeeding rate [ Time Frame: 1 month postpartum ]
Proportion of mothers who are exclusively breastfeeding
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 18, 2018)
  • 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 ]
    Rate of breastfeeding-associated complications such as sore nipple, mastitis, pain, bleeding, breast engorgement
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: May 8, 2018)
  • 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 ]
    Rate of breastfeeding-associated complications such as sore nipple, mastitis, pain, bleeding, breast engorgement
  • Maternal satisfaction with breastfeeding [ Time Frame: 1 week postpartum ]
    Maternal satisfaction with breastfeeding assessed with the validated Maternal Breastfeeding Evaluation Scale
  • Maternal quality of life [ Time Frame: 1 month postpartum ]
    Maternal quality of life assessed with the validated Postpartum Quality of Life instrument
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Breastfeeding Success With the Use of the WHO Syringe Technique for Management of Inverted Nipples in Lactating Women
Official Title  ICMJE 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
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Breastfeeding
  • Inverted Nipple
Intervention  ICMJE Other: Inverted syringe
Application of mild suction over the mother's inverted nipple using an inverted syringe before each breastfeeding.
Study Arms  ICMJE
  • 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.
    Intervention: Other: Inverted syringe
  • 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. .
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 8, 2018)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 30, 2021
Estimated Primary Completion Date May 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Listed Location Countries  ICMJE Lebanon
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03529630
Other Study ID Numbers  ICMJE PED.MN.15
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
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
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Informed Consent Form (ICF)
Supporting Materials: Clinical Study Report (CSR)
Supporting Materials: Analytic Code
Time Frame: After December 2021.
Access Criteria: Request data sharing from the principal investigator.
Responsible Party Mona Nabulsi, American University of Beirut Medical Center
Study Sponsor  ICMJE American University of Beirut Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account American University of Beirut Medical Center
Verification Date July 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP