MedPath

Antenatal Breastmilk Expression From Week 34 of Gestation

Not Applicable
Completed
Conditions
Breastfeeding
Healthy
Breastmilk Expression
Collection, Breastmilk
Interventions
Behavioral: Antenatal breastmilk expression
Behavioral: Breastfeeding consultation
Registration Number
NCT05516199
Lead Sponsor
Odense University Hospital
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
Female
Target Recruitment
60
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)
Read More
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
Read More

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Antenatal breastmilk expressionAntenatal breastmilk expressionBreastfeeding consultation with trained midwife in week 33 + antenatal breastmilk expression from week 34
Antenatal breastmilk expressionBreastfeeding consultationBreastfeeding consultation with trained midwife in week 33 + antenatal breastmilk expression from week 34
ControlBreastfeeding consultationBreastfeeding consultation with trained midwife in week 33
Primary Outcome Measures
NameTimeMethod
Gestational age at birth in the two groupsThrough 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 Outcome Measures
NameTimeMethod
Number of weekly breastmilk expressions before birthThrough study completion, an avarage of 1 year.

Number of weekly expressions in interventiongroup. Measured through the weekly push-messages.

Breastfeeding rates 1, 2, 4 and 8 weeks after birthThrough study completion, an avarage of 1 year.

Measured through weekly self-reported push-messages in both groups

Amount of breastmilk expressedThrough 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.

Number of exclusively breastfeeding versus partially breastfeeding women in each group at 1, 2, 4 and 8 weeks after birth1, 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 expressionThrough study completion, an avarage of 1 year.

Contractions and/or fetal stimulation during the first breastmilk expression during pregnancy, assessed with CTG

Trial Locations

Locations (1)

Odense University Hospital

🇩🇰

Odense, Denmark

© Copyright 2025. All Rights Reserved by MedPath