Antenatal Breastmilk Expression From Week 34 of Gestation (EXPRESS-MOM)

Odense University Hospital

Status: Completed

Conditions: Healthy; Collection, Breastmilk; Breastfeeding; Breastmilk Expression

Treatments: Behavioral: Antenatal breastmilk expression; Behavioral: Breastfeeding consultation

Study type: Interventional

Funder types: Other

Identifiers

NCT05516199

OUH-HCA005

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Antenatal breastmilk expression

Experimental group

Description:

Breastfeeding consultation with trained midwife in week 33 + antenatal breastmilk expression from week 34

Treatment:

Behavioral: Breastfeeding consultation

Behavioral: Antenatal breastmilk expression

Control

Other group

Description:

Breastfeeding consultation with trained midwife in week 33

Treatment:

Behavioral: Breastfeeding consultation