EXPRESSMOM2 in Pregnant Women at High Risk of Preterm Birth. Aspects of Antenatal Breastmilk Expression and Safety From Gestational Week 28-34 and Potential Nutritional Benefits for the Newborn Infant.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 250
- 主要终点
- Number of days from randomization to birth
研究概览
简要总结
In this randomized controlled study, the investigators aim to examine if antenatal breastmilk expression (aBME) from week 28 in high-risk pregnancies is a safe and effective method to ensure early access to mother's own milk.
In addition, this study will analyze and compare colostrum from pregnancy with colostrum after birth, investigates women's confidence in breastfeeding and breastfeeding establishment as well as measures oxytocin levels during aBME and active labour with no aBME.
详细描述
In this study 250 pregnant women at high risk of preterm birth (Diagnosed with either preeclampsia or PPROM or previously delivered preterm before week 34) from the Region of Southern Denmark, will be randomized into an intervention or a control group.
Women in the intervention group will be instructed to perform antenatal breastmilk expression twice daily for 5 minutes on each breast from inclusion at week 28-34 until birth. Women will be advised to collect any expressed milk and bring to the delivery ward for use after birth.
A total of 40 minutes of Cardio Toco Graphy (CTG) will be performed before, during and after they perform aBME for the first time, to detect any uterine contractions or foetal compromise due to stimulation. If the CTG is normal the women can begin aBME at home.
Furthermore, the women will be asked to answer a questionnaire about breastfeeding self-efficacy at inclusion and 2 weeks after aBME starts. Small amounts of the colostrum expressed before and after birth will be analysed for specific proteins, bioactive components and amount and types of Lactobacillus strains.
Women admitted to Odense University Hospital will be asked for a single blood sample to measure oxytocin. Samples will be drawn during the first aBME and at birth.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- •Pregnant women with a GA between 28 weeks and 0 days and 34 weeks and 0 days who are either diagnosed with preeclampsia or PPROM or have previously given birth before 34 weeks of gestation
- •Resident in the Region of Southern Denmark
- •Women speaking and understanding Danish or English
- •Planning to breastfeed their infants
排除标准
- •HELLP or severe preeclampsia indicating expected induction of labour/caesarean section within a few days (According to national guidelines)
- •Chorioamnionitis indicating induction of labour/caesarean section within a few days
- •Women with a vaginal cerclage and PPROM
- •Women taking medications contraindicating breastfeeding
- •Women with prior breast reductive surgery or mastectomy
- •Below 18 years of age
- •Contractions to a certain extend expecting delivery within a few days
- •Included in other trials, where breastfeeding is among outcomes
结局指标
主要结局
Number of days from randomization to birth
时间窗: From date of randomization at 28 weeks to 34 weeks of pregnancy until the date of birth. Up to 100 days.
To investigate the safety of antenatal breastmilk expression in pregnant women at high risk of preterm birth included from week 28 to 34 of pregnancy
次要结局
- Amount of available mothers own milk at birth(At birth)
- Oxytocin levels(At two time points. Baseline at randomization for the control group and during the first time with handstimulation of the breast in the intervention group. Second time point in both groups: During active labour.)
- Colostrum analysis(From pregnancy to one week after birth)
- Postnatal outcomes in infants (Height in cm, weight in kg, hospital treatments, admittance to NICU, duration of admittance, occurence of infections, nutrition, early feeding, hypoglyceamia)(From date of birth to six months post partum.)
- Maternal breastfeeding self-efficacy changes in questionnaires.(From date of randomization to 3 weeks post-partum)
- Breastfeeding establishment after antental breastmilk expression in obese women(At 4-6 weeks post-partum)
- Observations regarding number of tools/strategies from antenatal breastmilk expression(Within the first 3 weeks of post-partum)
- Number of women exclusively breastfeeding.(From date of birth to 3 weeks post partum.)