Prenatal Diagnosis and Treatment of Flat, Inverted and Retracted Nipples to Improve Postpartum Breastfeeding Rates
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- Mayo Clinic
- 试验地点
- 2
- 主要终点
- Percent of women with change in nipple elongation following use of Supple Cups in the prenatal period
研究概览
简要总结
The objectives of this study are to determine the population occurrence rate of flat, inverted, or retracted nipples (FIRN) in pregnant women in our obstetrical practice through prenatal evaluation at the NOB visit and re-evaluation at the 28th-30th week of gestation, to determine the benefit of using Supple Cups as treatment for FIRN for 6-8 weeks in the third trimester to evert the nipples prior to delivery, and to evaluate the effect of prenatal diagnosis and treatment of FIRN on establishment of latch and breastfeeding rates in the postpartum period.
详细描述
It is well established that breastfeeding is the most clinically optimal method of feeding for infants through the first year of life, however exclusive breastfeeding rates in the United States remain low. Many women have difficulty establishing breastfeeding in the first few weeks after birth which leads to the use of formula supplementation. For approximately 10% of women this difficulty is caused by flat, inverted or retracted nipples (FIRN) which make it very difficult to latch when attempting to breastfeed. Many women are not diagnosed with FIRN until after the baby is born.
Supple Cups are promising as a prenatal and postnatal intervention to elongate nipples in cases of FIRN, allowing women with these biological variations to successfully breastfeed. If women are diagnosed in the early prenatal period with FIRN, Supple Cup use can be initiated to elongate and prepare the nipples for breastfeeding postpartum. Pre-natal diagnosis of FIRN is critical to enable breastfeeding immediately postpartum.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women ≥ 18 years of age
- •Pregnant at time of enrollment
- •Plan to breastfeed their infant following birth
- •Plan delivery at Mayo Clinic Hospital
- •One or more flat, inverted or retracted nipple diagnosed by a healthcare professional
排除标准
- •History of breast surgery or nipple piercings
- •History of significant low milk supply requiring discontinuation of breastfeeding prior to six weeks postpartum
- •History of preterm labor and/or birth
- •History of high-risk medical condition that increases patient risk for preterm labor and/or birth
- •History of Raynaud's syndrome and/or hypersensitivity to palpation of breasts
- •Current multiple gestation pregnancy
- •Active rash, infection, or lesions on the nipple at time of initiation of Supple Cups
结局指标
主要结局
Percent of women with change in nipple elongation following use of Supple Cups in the prenatal period
时间窗: At completion of 6 weeks of Supple Cups use during the prenatal period
Visual assessment and documented description of change in elongation of nipple after using Supple Cups prior to birth
次要结局
- Percent of women with established breastfeeding with adequate infant latch(One week postpartum)
研究者
Miriam (Miri) E. Levi
Principal Investigator
Mayo Clinic