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

Sponsor
Odense University Hospital
Study ID
NCT07191366
Status
Not Yet Recruiting

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Conditions

  • PPROM
  • Preeclampsia
  • Preterm Birth
  • Previous Preterm Birth

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Handstimulation of breast — PROCEDURE
    Hand stimulation of the breast

Study Details

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.

Key Dates

First listed
Sep 24, 2025
Start date
Sep 30, 2026
Status verified
Aug 2025
Primary completion
Jan 31, 2029
Completion
Jul 31, 2029

Study Design

Enrollment
250 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Handstimulation of the breasts
    Antenatal breastmilk expression and colostrum collection
  • No Intervention: Control

Primary Outcome Measure

Number of days from randomization to birth [ Time Frame: From date of randomization at 28 weeks to 34 weeks of pregnancy until the date of birth. Up to 100 days. ]

Central Contacts

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