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

NCT ID: NCT07191366

Last Updated: 2025-09-24

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 250 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-09-30
• Study Completion Date: 2029-07-31

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.

Detailed Description

In this study 250 pregnant women at high risk of preterm birth (Diagnosed with either preeclampsia or PPROM or previously delivered preterm before week 34) from the Region of Southern Denmark, will be randomized into an intervention or a control group.

Women in the intervention group will be instructed to perform antenatal breastmilk expression twice daily for 5 minutes on each breast from inclusion at week 28-34 until birth. Women will be advised to collect any expressed milk and bring to the delivery ward for use after birth.

A total of 40 minutes of Cardio Toco Graphy (CTG) will be performed before, during and after they perform aBME for the first time, to detect any uterine contractions or foetal compromise due to stimulation. If the CTG is normal the women can begin aBME at home.

Furthermore, the women will be asked to answer a questionnaire about breastfeeding self-efficacy at inclusion and 2 weeks after aBME starts. Small amounts of the colostrum expressed before and after birth will be analysed for specific proteins, bioactive components and amount and types of Lactobacillus strains.

Women admitted to Odense University Hospital will be asked for a single blood sample to measure oxytocin. Samples will be drawn during the first aBME and at birth.

8 women/parents will be asked to participate in an observational study. Observations will follow breastfeeding practices within the first two days and afterward, weekly, during the first three weeks postpartum.

A subgroup of 12 mothers with a pre-pregnancy BMI above ≥30kg/m2 who give birth at term will be asked to participate in an in-depth face-to-face interview. The interviews will be conducted in the participant´s home 4-6 weeks postpartum to explore experiences with breastfeeding establishment after performing aBME.

The women in the control group will follow standard care and be asked to answer a questionnaire about breastfeeding self-efficacy at inclusion. Furthermore, women admitted to Odense University Hospital will be asked for a single blood sample to measure oxytocin. The sample will be drawn during randomization and at birth.

After birth, 8 women/parents will be asked to participate in an observational study. Observations will follow breastfeeding practices within the first two days and, afterward, weekly during the first three weeks.

The women from both groups will be followed until 6 months postpartum to monitor outcomes related to breastfeeding, nutrition, growth, and infections. Until four weeks after the infant's corrected age, all women in both groups receive weekly push messages through the smartphone application, including questions on feeding postpartum. If admitted, the feeding will be registered at the hospital through electronic health records. The following five months, all women in both groups will receive monthly push messages through the smartphone application, including post-partum feeding questions.

Furthermore, all women will be asked to answer a questionnaire related to breastfeeding self-efficacy 3 weeks after birth.

Conditions

Preterm Birth; PPROM; Preeclampsia; Previous Preterm Birth

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Handstimulation of the breasts

Antenatal breastmilk expression and colostrum collection

Group Type: EXPERIMENTAL

Handstimulation of breast

Intervention Type: PROCEDURE

Hand stimulation of the breast

Control

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Handstimulation of breast

Hand stimulation of the breast

Intervention Type: PROCEDURE

Other Intervention Names

aBME; Breastmilk expression

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Aabenraa Hospital

OTHER

Sponsor Role: collaborator

Esbjerg Hospital - University Hospital of Southern Denmark

OTHER

Sponsor Role: collaborator

Kolding Sygehus

OTHER

Sponsor Role: collaborator

University of Aarhus

OTHER

Sponsor Role: collaborator

Odense University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gitte Zachariassen, MD, phd

Role: STUDY_CHAIR

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

Christina A Vinter, MD, phd

Role: STUDY_CHAIR

The Department of Gynaecology and Obstetrics, Odense University Hospital

Leonora S Borum, MD

Role: PRINCIPAL_INVESTIGATOR

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

Sarah B Bentzen, Midwife

Role: PRINCIPAL_INVESTIGATOR

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

Central Contacts

Gitte Zachariassen, Professor, MD, ph.d.

Role: CONTACT

gitte.zachariassen@rsyd.dk

+4522402549

Leonora S Borum, MD

Role: CONTACT

leonora.semine.borum@rsyd.dk

+4550541738

Other Identifiers

OUH-HCA042

Identifier Type: -

Identifier Source: org_study_id