Clinical Research Details

Descriptive Information
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

Mona Nabulsi
mn04@aub.edu.lb

PED.MN.15
Completed

Clinical Research - Clinical Trials (phase 0, 1,2 3 & 4)  

Phase 3  

No
Collaborators
  • Dr. Ali Khalil
  • Dr. Rayan Ghanem
  • Marlie Abou Jawdeh
Sponsors
  • Medical Practice Plan
Conditions and Keywords
Breastfeeding success in mothers with inverted nipples.
Breastfeeding, Inverted nipples, Clinical trial
Study Design
Treatment
Safety and/or Efficacy Study
Prospective
Open Label
Parallel-Group
Randomized
N/A: Not Applicable
Eligibility and IRB
Female
Min: 18
Max: 50
In Progress
No

 This is an open-label randomized clinical trial designed to investigate the effectiveness of the use of inverted syringe on the 1-month exclusive breastfeeding rate in women with inverted nipples.


 Healthy pregnant women (at or more than 37 weeks of gestation), with grades 1 and 2 inverted nipples, intending to give breastfeeding a try.


  100 women will be recruited on consecutive basis.



 Healthy pregnant women in their 37th week of gestation or more who have inverted nipples of grades 1 or 2, visiting the Women’s Health Center (WHC), the obstetric Out Patient Department (OPD), clinic of Dr. Ali Khalil, or the Delivery Suite (DS) of the American University of Beirut Medical Center (AUBMC). 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. Women should also be able to read and write.


  We will exclude 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, and women choosing artificial milk as their preferred infant nutrition. Women with term twin gestation will not be excluded.