Antenatal Breastmilk Expression From Week 34 of Gestation Safety in Pregnancy and Benefits for the Newborn Infant: A Pilot Randomized Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Gestational age at birth in the two groups
研究概览
简要总结
In this pilot study, the investigators aim to examine if antenatal breastmilk expression from week 34 of pregnancy is a safe and feasible procedure for the mother and fetus. Furthermore, the investigators want to evaluate breastfeeding rates.
详细描述
In a randomized pilot study, 60 healthy pregnant women will be randomized either to antenatal breastmilk expression from week 34+0 until delivery or no antenatal breastmilk expression. Furthermore, all participants will have an individual breastfeeding consultation with a trained midwife in week 33 of pregnancy. At the consultation, the intervention group will also be taught how to perform antenatal expression by hand and store any expressed breastmilk correctly. All women included in this study will receive standard care.
To detect signs of uterine contractions or fetal reaction in relation to stimulation of the breast, a cardiotocography (CTG) will be performed before, during and after the first expression in the intervention group. If the CTG is normal the women can perform breastmilk expression by hand 5 minutes at each breast two times per day until birth, and collect and store any expressed milk.
During the intervention and 8 weeks after birth the participating women will receive weekly push-messages through an application on their smartphone. The messages include short questions about the handexpression of milk in pregnancy as well as regarding feeding of the infant after birth. At the end of the study the mothers will be invited for an interview to investigate their experience with the procedure, but this is an independent study and therefore not a part of this protocol.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Healthy nulliparous women with no major chronic or pregnancy related diseases
- •Danish speaking
- •Singleton pregnancies
- •Planning to exclusively breastfeed their infants and deliver at Odense University Hospital (Odense and Svendborg)
排除标准
- •Suspected fetal intrauterine growth restriction or known major fetal anomaly
- •Women at risk of preterm birth with one of the following diagnoses: Placenta previa, premature preterm rupture of membranes (PPROM) or previous cervical conization
- •Women taking medications where breastfeeding is contraindicated
- •Women with prior breast surgery: Breast reductive surgery or breast implants
结局指标
主要结局
Gestational age at birth in the two groups
时间窗: Through study completion, an avarage of 1 year.
Gestational age of infant at birth. Information will be found through medical records. In the weekly push-messages the women have to answer if they have been giving birth. If they click yes, investigators get a notification and find gestational age and baseline infant characteristics through medical records.
次要结局
- Amount of breastmilk expressed(Through out the study, an average of 1 year. Assesment when all women included have been giving birth.)
- Number of exclusively breastfeeding versus partially breastfeeding women in each group at 1, 2, 4 and 8 weeks after birth(1, 2, 4 and 8 weeks after birth)
- Adverse reactions from mother or fetus during first breastmilk expression(Through study completion, an avarage of 1 year.)
- Number of weekly breastmilk expressions before birth(Through study completion, an avarage of 1 year.)
- Breastfeeding rates 1, 2, 4 and 8 weeks after birth(Through study completion, an avarage of 1 year.)
研究者
Marie Bendix Simonsen, M.D.
Principal Investigator
Odense University Hospital