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Antenatal Breastmilk Expression in Pregnant Women at High Risk of Preterm Birth

NCT07191366 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 250

Last updated 2025-09-24

No results posted yet for this study

Summary

In this randomized controlled study, the investigators aim to examine if antenatal breastmilk expression (aBME) from week 28 in high-risk pregnancies is a safe and effective method to ensure early access to mother's own milk.

In addition, this study will analyze and compare colostrum from pregnancy with colostrum after birth, investigates women's confidence in breastfeeding and breastfeeding establishment as well as measures oxytocin levels during aBME and active labour with no aBME.

Conditions

Interventions

PROCEDURE

Handstimulation of breast

Hand stimulation of the breast

Sponsors & Collaborators

  • Aabenraa Hospital

    collaborator OTHER

  • Esbjerg Hospital - University Hospital of Southern Denmark

    collaborator OTHER

  • Kolding Sygehus

    collaborator OTHER

  • University of Aarhus

    collaborator OTHER

  • Odense University Hospital

    lead OTHER

Principal Investigators

  • Gitte Zachariassen, MD, phd · The Hans Christian Andersen Children's Hospital, Odense University Hospital

  • Christina A Vinter, MD, phd · The Department of Gynaecology and Obstetrics, Odense University Hospital

  • Leonora S Borum, MD · The Hans Christian Andersen Children's Hospital, Odense University Hospital

  • Sarah B Bentzen, Midwife · The Hans Christian Andersen Children's Hospital, Odense University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-09-30
Primary Completion
2029-01-31
Completion
2029-07-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07191366 on ClinicalTrials.gov