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Completed

NCT Number: NCT03529630

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

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.

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Key information

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

American University of Beirut Medical Center

Beirut, Lebanon

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Inverted syringe

Other

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

Primary outcomes

  1. One month exclusive breastfeeding rate

    Time frame: 1 month postpartum

    Proportion of mothers who are exclusively breastfeeding

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

American University of Beirut Medical Center

Other

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
May 18, 2018
Registry last updated
Mar 2, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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