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

NCT07191366 | Not Yet Recruiting DMC

• 1 other identifier: OUH-HCA042
• Study Type: interventional
• Target: 250
• Locations: 0 countries
• Sites: N/A

Brief 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

Preterm Birth; PPROM; Preeclampsia; Previous Preterm Birth

Keywords

Antenatal breastmilk expression; ABME; Preterm birth; PPROM; Preeclampsia; Previous preterm birth; Colostrum; Colostrum analysis; Safety; self-efficacy

Outcome Measures

Primary Outcomes (1)

• Number of days from randomization to birth

  To investigate the safety of antenatal breastmilk expression in pregnant women at high risk of preterm birth included from week 28 to 34 of pregnancy

  From date of randomization at 28 weeks to 34 weeks of pregnancy until the date of birth. Up to 100 days.

Secondary Outcomes (8)

• Amount of available mothers own milk at birth

  At birth

• Oxytocin levels

  At two time points. Baseline at randomization for the control group and during the first time with handstimulation of the breast in the intervention group. Second time point in both groups: During active labour.

• Colostrum analysis

  From pregnancy to one week after birth

• Postnatal outcomes in infants (Height in cm, weight in kg, hospital treatments, admittance to NICU, duration of admittance, occurence of infections, nutrition, early feeding, hypoglyceamia)

  From date of birth to six months post partum.

• Maternal breastfeeding self-efficacy changes in questionnaires.

  From date of randomization to 3 weeks post-partum

Study Arms (2)

Handstimulation of the breasts

EXPERIMENTAL

Antenatal breastmilk expression and colostrum collection

Procedure: Handstimulation of breast

Control

NO INTERVENTION

Interventions

Handstimulation of breast PROCEDURE

Hand stimulation of the breast

Also known as: aBME, Breastmilk expression

Handstimulation of the breasts

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pregnant women with a GA between 28 weeks and 0 days and 34 weeks and 0 days who are either diagnosed with preeclampsia or PPROM or have previously given birth before 34 weeks of gestation
• Resident in the Region of Southern Denmark
• Women speaking and understanding Danish or English
• Planning to breastfeed their infants

You may not qualify if:

• HELLP or severe preeclampsia indicating expected induction of labour/caesarean section within a few days (According to national guidelines)
• Chorioamnionitis indicating induction of labour/caesarean section within a few days
• Women with a vaginal cerclage and PPROM
• Women taking medications contraindicating breastfeeding
• Women with prior breast reductive surgery or mastectomy
• Below 18 years of age
• Contractions to a certain extend expecting delivery within a few days
• Included in other trials, where breastfeeding is among outcomes

Sponsors & Collaborators

• Odense University Hospital: lead
• Aabenraa Hospital: collaborator
• Esbjerg Hospital - University Hospital of Southern Denmark: collaborator
• Kolding Sygehus: collaborator
• University of Aarhus: collaborator

MeSH Terms

Conditions

Premature Birth; Preterm Premature Rupture of the Membranes; Pre-Eclampsia

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Hypertension, Pregnancy-Induced

Study Officials

• Gitte Zachariassen, MD, phd

  The Hans Christian Andersen Children's Hospital, Odense University Hospital

  STUDY CHAIR

• Christina A Vinter, MD, phd

  The Department of Gynaecology and Obstetrics, Odense University Hospital

  STUDY CHAIR

• Leonora S Borum, MD

  The Hans Christian Andersen Children's Hospital, Odense University Hospital

  PRINCIPAL INVESTIGATOR

• Sarah B Bentzen, Midwife

  The Hans Christian Andersen Children's Hospital, Odense University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gitte Zachariassen, Professor, MD, ph.d.

CONTACT

+4522402549; gitte.zachariassen@rsyd.dk

Leonora S Borum, MD

CONTACT

+4550541738; leonora.semine.borum@rsyd.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 1, 2025
• First Posted: September 24, 2025
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): January 1, 2029
• Study Completion (Estimated): July 1, 2029
• Last Updated: September 24, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share