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

Breastfeeding Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03529630
• Other study ID #: PED.MN.15
• Status: Completed
• Phase: N/A
• Start date: June 1, 2018
• Est. completion date: July 15, 2020

Study information

• Verified date: February 2022
• Source: American University of Beirut Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: July 15, 2020
• Est. primary completion date: February 25, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Breastfeeding
• Inverted Nipple

Intervention

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

Locations

Country	Name	City	State
Lebanon	American University of Beirut Medical Center	Beirut

Sponsors (1)

Lead Sponsor	Collaborator
American University of Beirut Medical Center

Country where clinical trial is conducted

Lebanon, 

References & Publications (19)

Alexander JM, Grant AM, Campbell MJ. Randomised controlled trial of breast shells and Hoffman's exercises for inverted and non-protractile nipples. BMJ. 1992 Apr 18;304(6833):1030-2. — View Citation

Belfort MB, Rifas-Shiman SL, Kleinman KP, Guthrie LB, Bellinger DC, Taveras EM, Gillman MW, Oken E. Infant feeding and childhood cognition at ages 3 and 7 years: Effects of breastfeeding duration and exclusivity. JAMA Pediatr. 2013 Sep;167(9):836-44. — View Citation

Binns C, Lee M, Low WY. The Long-Term Public Health Benefits of Breastfeeding. Asia Pac J Public Health. 2016 Jan;28(1):7-14. doi: 10.1177/1010539515624964. Review. — View Citation

Chakrabarti K, Basu S. Management of flat or inverted nipples with simple rubber bands. Breastfeed Med. 2011 Aug;6(4):215-9. doi: 10.1089/bfm.2010.0028. Epub 2011 Jan 8. — View Citation

Chan AW, Tetzlaff JM, Altman DG, Laupacis A, Gøtzsche PC, Krleža-Jeric K, Hróbjartsson A, Mann H, Dickersin K, Berlin JA, Doré CJ, Parulekar WR, Summerskill WS, Groves T, Schulz KF, Sox HC, Rockhold FW, Rennie D, Moher D. SPIRIT 2013 statement: defining standard protocol items for clinical trials. Ann Intern Med. 2013 Feb 5;158(3):200-7. doi: 10.7326/0003-4819-158-3-201302050-00583. — View Citation

Han S, Hong YG. The inverted nipple: its grading and surgical correction. Plast Reconstr Surg. 1999 Aug;104(2):389-95; discussion 396-7. — View Citation

Hill PD, Aldag JC, Hekel B, Riner G, Bloomfield P. Maternal Postpartum Quality of Life Questionnaire. J Nurs Meas. 2006 Winter;14(3):205-20. — View Citation

Kesaree N, Banapurmath CR, Banapurmath S, Shamanur K. Treatment of inverted nipples using a disposable syringe. J Hum Lact. 1993 Mar;9(1):27-9. — View Citation

Kramer MS, Kakuma R. Optimal duration of exclusive breastfeeding. Cochrane Database Syst Rev. 2012 Aug 15;(8):CD003517. doi: 10.1002/14651858.CD003517.pub2. Review. — View Citation

Leff EW, Jefferis SC, Gagne MP. The development of the Maternal Breastfeeding Evaluation Scale. J Hum Lact. 1994 Jun;10(2):105-11. — View Citation

McGeorge DD. The "Niplette": an instrument for the non-surgical correction of inverted nipples. Br J Plast Surg. 1994 Jan;47(1):46-9. — View Citation

Nabulsi M, Hamadeh H, Tamim H, Kabakian T, Charafeddine L, Yehya N, Sinno D, Sidani S. A complex breastfeeding promotion and support intervention in a developing country: study protocol for a randomized clinical trial. BMC Public Health. 2014 Jan 15;14:36. doi: 10.1186/1471-2458-14-36. — View Citation

Riordan JM, Woodley G, Heaton K. Testing validity and reliability of an instrument which measures maternal evaluation of breastfeeding. J Hum Lact. 1994 Dec;10(4):231-5. — View Citation

Section on Breastfeeding. Breastfeeding and the use of human milk. Pediatrics. 2012 Mar;129(3):e827-41. doi: 10.1542/peds.2011-3552. Epub 2012 Feb 27. Review. — View Citation

SKOOG T. An operation for inverted nipples. Br J Plast Surg. 1952 Apr;5(1):65-9. — View Citation

Terrill PJ, Stapleton MJ. The inverted nipple: to cut the ducts or not? Br J Plast Surg. 1991 Jul;44(5):372-7. — View Citation

Victora CG, Bahl R, Barros AJ, França GV, Horton S, Krasevec J, Murch S, Sankar MJ, Walker N, Rollins NC; Lancet Breastfeeding Series Group. Breastfeeding in the 21st century: epidemiology, mechanisms, and lifelong effect. Lancet. 2016 Jan 30;387(10017):475-90. doi: 10.1016/S0140-6736(15)01024-7. Review. — View Citation

Victora CG, Horta BL, Loret de Mola C, Quevedo L, Pinheiro RT, Gigante DP, Gonçalves H, Barros FC. Association between breastfeeding and intelligence, educational attainment, and income at 30 years of age: a prospective birth cohort study from Brazil. Lancet Glob Health. 2015 Apr;3(4):e199-205. doi: 10.1016/S2214-109X(15)70002-1. — View Citation

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* Note: There are 19 references in all — Click here to view all references

Outcome

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