Breastfeeding, Breastmilk Expression, Collection, Breastmilk, Healthy
Conditions
Keywords
Infant nutrition, Lactation, Breastmilk, Breastfeeding
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALAntenatal breastmilk expression
Stimulation of the breast by hand/handexpression of breastmilk during pregnancy from week 34
BEHAVIORALBreastfeeding consultation
60 min standardized breastfeeding consultation with a trained midwife, with focus on practical breastfeeding skills
Sponsors
University of Southern Denmark
Odense University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Intervention model description
Parallel Assignment
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
1. Healthy nulliparous women with no major chronic or pregnancy related diseases 2. BMI \<27 3. Danish speaking 4. Singleton pregnancies 5. Planning to exclusively breastfeed their infants and deliver at Odense University Hospital (Odense and Svendborg)
Exclusion criteria
1. Suspected fetal intrauterine growth restriction or known major fetal anomaly 2. Women at risk of preterm birth with one of the following diagnoses: Placenta previa, premature preterm rupture of membranes (PPROM) or previous cervical conization 3. Women taking medications where breastfeeding is contraindicated 4. Women with prior breast surgery: Breast reductive surgery or breast implants
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Gestational age at birth in the two groups | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of weekly breastmilk expressions before birth | Through study completion, an avarage of 1 year. | Number of weekly expressions in interventiongroup. Measured through the weekly push-messages. |
| Amount of breastmilk expressed | Through out the study, an average of 1 year. Assesment when all women included have been giving birth. | How many women will be capable of expressing any milk before birth in intervention group, and how many ml. Volume is measured by each women using a container with a mL scale and reported through weekly self reported push-messages. |
| Breastfeeding rates 1, 2, 4 and 8 weeks after birth | Through study completion, an avarage of 1 year. | Measured through weekly self-reported push-messages in both groups |
| 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 | Measured through the weekly self-reported push-messages in both groups |
| Adverse reactions from mother or fetus during first breastmilk expression | Through study completion, an avarage of 1 year. | Contractions and/or fetal stimulation during the first breastmilk expression during pregnancy, assessed with CTG |
Countries
Denmark
Outcome results
None listed