Clinical trial NCT05516199: Antenatal Breastmilk Expression From Week 34 of Gestation
Official title: Antenatal Breastmilk Expression From Week 34 of Gestation Safety in Pregnancy and Benefits for the Newborn Infant: A Pilot Randomized Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breastmilk Expression
Collection, Breastmilk
Breastfeeding
Healthy
Keywords: Infant nutrition
Lactation
Breastmilk
Breastfeeding
Lead sponsor: Odense University Hospital
Sponsor class: OTHER
Collaborators: name: University of Southern Denmark
First posted: 2022-08-25
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel Assignment
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Gestational age at birth in the two groups
timeFrame: Through study completion, an avarage of 1 year.
Secondary outcomes:
measure: Number of weekly breastmilk expressions before birth
timeFrame: Through study completion, an avarage of 1 year.
measure: Amount of breastmilk expressed
timeFrame: Through out the study, an average of 1 year. Assesment when all women included have been giving birth.
measure: Breastfeeding rates 1, 2, 4 and 8 weeks after birth
timeFrame: Through study completion, an avarage of 1 year.
measure: Number of exclusively breastfeeding versus partially breastfeeding women in each group at 1, 2, 4 and 8 weeks after birth
timeFrame: 1, 2, 4 and 8 weeks after birth
measure: Adverse reactions from mother or fetus during first breastmilk expression
timeFrame: Through study completion, an avarage of 1 year.
Other outcomes:
Locations:
city: Odense
country: Denmark
facility: Odense University Hospital
Study officials:
affiliation: OUH & SDU
name: Marie B Simonsen, M.D
role: PRINCIPAL_INVESTIGATOR
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