Effect of an Immediate-postpartum Support by IBCLC to Women With Obesity, on Breastfeeding Performance: A Randomized Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 261
- 试验地点
- 2
- 主要终点
- Predominant breastfeeding prevalence
研究概览
简要总结
Investigators propose this study in order to answer the following research question: An educational intervention and breastfeeding support at postpartum will increase the frequency and total breastfeeding duration in the intervention group? This is a randomized (with control and intervention groups) study, open and parallel (1: 1 ratio between study groups) with 200 pregnant women in the second or third trimester, according to their body mass index (BMI, kg / m2) with excess weight (BMI> 29 pre-pregnancy weight) and that will address their pregnancy in the public health services and hospitals belonging to the Health Ministry of 5 districts: Coyoacán, Magdalena Contreras, Tlalpan, Xochimilco and Alvaro Obregón in Mexico City.
The intervention group and the control group will have the same characteristics for eligibility.
The main phases to develop the study are PHASE 1. INTERVENTION DESIGN PHASE 2. IMPLEMENTATION OF THE INTERVENTION. PHASE 3. FOLLOW-UP The intervention will be offered at 3 times: 1) Educational intervention (a workshop) to pregnant obese women. The workshop will be held by an International Board Certified Lactation Consultant (IBCLC) to promote exclusive breastfeeding and to encourage a better breastfeeding performance in accordance with the WHO recommendations. The workshop will be held at convenient times and will be conducted for groups of 8 to 10 participants; 2) Immediate breastfeeding support at hospital by an IBCLC and; 3) The women will be exposed to early telephonic follow-up during the first week of their children´s lives and each month until six months of life. Then, if the breastfeeding continues, every two months until the first year of their children´s life.
At the first month postpartum, investigators will visit participants at home, both the control group and the intervention group, for collecting information on breastfeeding practices, for taking a breast milk sample to estimate its fatty acids content, and a blood sample (serum) to obtain the C-Reactive Protein. Also, the investigators will take anthropometric measurements of the children to evaluate their growth (weight, length, and skinfold thickness). Investigators will ask for breastfeeding practices and diet of the participants through a 24 hours recall.
The results of this intervention group will be compared with the control group: pregnant obese women without educational intervention or telephonic follow-up.
详细描述
BACKGROUND Maternal obesity alters the composition of the breast milk beyond the influence of diet on it. Obesity delays copious production of breast milk (Lactogenesis stage II) and it concurs with the synthesis of prolactin (PRL), in response to the decreased sucking of the child.
Besides that, obese mothers have a higher risk of complications in the delivery; where it is common to experience great physiological stress and having a high probability of cesarean, which metabolically does not interfere with breastfeeding but delays its establishment. The excess of subcutaneous fat in the area of the areola of mothers with obesity cause discomfort and stress in the mother and crying in the infant, hindering the correct latch of the infant to the nipple, weakening the neurological stimulus that triggers Prolactin production.
Also, obese mothers have reported an increased feeling of insufficient milk, compared with non-obese mothers and, women with obesity report lower self-efficacy than their pairs without obesity.
Despite the implementation of educational interventions to promote the establishment of breastfeeding in obese women, the results have not been favorable to increase the prevalence of breastfeeding.
To help to improve this practice in women with obesity, it raises the following research question:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 15 Years 至 —（Child, Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pregnant Women <18 years old with a BMI >=28, and women <18 years old with a BMI >=27, utilizing their pre-pregnancy weight.
- •Pregnant women within the second or early third trimester (week 20 through week 34 of gestation).
排除标准
- •Pregnant women under 15 years old.
- •Pregnant women diagnosed with HIV or AIDS, Hepatitis B and C, or the Human T lymphotropic virus. In the presence of these, women have the contraindication to feed their children with breast milk.
- •Pregnant women with medical conditions that could interfere with breastfeeding, as severe infections transmitted through breast milk.
- •Pregnant women with previous breast surgery (as breast reduction) because the lactiferous ducts end up damaged and may lead to poor or no milk production at all.
- •Pregnant women that are taking medications that prevent carrying out breastfeeding.
- •Pregnant women with a multiple pregnancy (in case of twins, the first born should be taken for the study).
- •Exit criteria:
- •Newborns with less than 35 weeks of gestational age.
- •Newborns dispatched to the neonatal intensive care unit (NICU) from the first day of life.
- •Newborns who present major congenital malformations, severe enough to prevent the breastfeeding.
- •Elimination criteria:
- •Newborns with hypertrophy (large for gestational age), because they may present hypoglycemia and therefore some should require to remain in fast even after starting oral feeding and especially on the first day of life.
- •Newborns that enter to the Intermediate Care Unit for a neonatal or maternal adverse event even if the breastfeeding was already initiated.
结局指标
主要结局
Predominant breastfeeding prevalence
时间窗: Within the first month of the child´s life
Percentage of 1 month old (+- 1 week) infants who consume breastmilk as the principal source of nourishment; this includes expressed human milk from own mother. Predominantly breastfed means that it is possible that the infant had received the day prior to the interview, other source of feeding (water and water-based drinks, fruit juice) ritual fluids or ORS, drops or syrups (vitamins, minerals and medicines), and it excludes the consumption of infant formula.
次要结局
- WHO Child Growth Standards(At the first month and at the 12 months of infant´s life)
- Exclusive breastfeeding prevalence(Within the first month of the child´s life)
- Total duration of breastfeeding(During the 12 months of the child´s life)
研究者
Sonia L. Hernandez Cordero
Professor
Universidad Iberoamericana A.C., Mexico