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Completed

NCT Number: NCT05516199

Antenatal Breastmilk Expression From Week 34 of Gestation

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.

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Key information

Conditions

Breastmilk Expression Behavior Breast Feeding Breast Milk Expression Breastfeeding Collection, Breastmilk Feeding Behavior Healthy

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Odense University Hospital

Odense, 5000, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy nulliparous women with no major chronic or pregnancy related diseases
  • BMI <27
  • Danish speaking
  • Singleton pregnancies
  • Planning to exclusively breastfeed their infants and deliver at Odense University Hospital (Odense and Svendborg)

Exclusion criteria

  • 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

Treatment and study plan

Antenatal breastmilk expression

Behavioral

Stimulation of the breast by hand/handexpression of breastmilk during pregnancy from week 34

Breastfeeding consultation

Behavioral

60 min standardized breastfeeding consultation with a trained midwife, with focus on practical breastfeeding skills

Primary outcomes

  1. Gestational age at birth in the two groups

    Time frame: 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 outcomes

  1. Number of weekly breastmilk expressions before birth

    Time frame: Through study completion, an avarage of 1 year.

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

  2. Amount of breastmilk expressed

    Time frame: 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.

  3. Breastfeeding rates 1, 2, 4 and 8 weeks after birth

    Time frame: Through study completion, an avarage of 1 year.

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

  4. Number of exclusively breastfeeding versus partially breastfeeding women in each group at 1, 2, 4 and 8 weeks after birth

    Time frame: 1, 2, 4 and 8 weeks after birth

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

  5. Adverse reactions from mother or fetus during first breastmilk expression

    Time frame: Through study completion, an avarage of 1 year.

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

Sponsors and collaborators

Lead sponsor

Odense University Hospital

Other

Collaborators

  • University of Southern Denmark

Registry information

Official study title

Antenatal Breastmilk Expression From Week 34 of Gestation Safety in Pregnancy and Benefits for the Newborn Infant: A Pilot Randomized Study

Acronym: EXPRESS-MOM

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Aug 25, 2022
Registry last updated
Jan 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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