Preterm BirthEXPRESSMOM2NCT07191366
Antenatal Breastmilk Expression in Pregnant Women at High Risk of Preterm Birth
A study testing Handstimulation of breast in people with Preterm Birth and PPROM, run by Odense University Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Preterm Birth, PPROM, Preeclampsia
- What is being tested?
- Handstimulation of breast
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- No sites listed yet
- Study dates
- Sep 2026to Jul 2029
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: EXPRESSMOM2 in Pregnant Women at High Risk of Preterm Birth. Aspects of Antenatal Breastmilk Expression and Safety From Gestational Week 28-34 and Potential Nutritional Benefits for the Newborn Infant.
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.
Read the 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
- Being tested
- Handstimulation of breast
- Keywords
- Antenatal breastmilk expression, ABME, Preterm birth, PPROM, Preeclampsia, Previous preterm birth, Colostrum, Colostrum analysis, Safety, self-efficacy
- Medical subject headings
- Premature Birth, Preterm Premature Rupture of the Membranes, Pre-Eclampsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Handstimulation of breastProcedure or surgery
Also called aBME, Breastmilk expression
Hand stimulation of the breast
| Study group | Role | What they receive |
|---|---|---|
| Handstimulation of the breasts | Experimental | Antenatal breastmilk expression and colostrum collection Receives: Procedure: Handstimulation of breast |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Availability of mothers own milk for the newborn infant after antenatal breastmilk expression in pregnancy
Measured: At birth
Oxytocin levels
To compare oxytocin levels from performing antenatal breastmilk expression or not
Measured: 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
To characterize macronutrients, microbial and bioactive composition in colostrum expressed before and after birth
Measured: 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)
To compare feeding intolerance, risk of infection and NEC in infants fed only mothers own milk compared to mothers own milk and/or donor human milk
Measured: From date of birth to six months post partum.
Maternal breastfeeding self-efficacy changes in questionnaires.
To investigate if antenatal breastmilk expression affects maternal breastfeeding self-efficacy.
Measured: From date of randomization to 3 weeks post-partum
Breastfeeding establishment after antental breastmilk expression in obese women
To examine experiences with breastfeeding establishment in women with obesity performing antenatal breastmilk expression or not
Measured: At 4-6 weeks post-partum
Observations regarding number of tools/strategies from antenatal breastmilk expression
Number of tools and strategies in breastfeeding establishment after performing antenatal breastmilk expression in pregnancy
Measured: Within the first 3 weeks of post-partum
Number of women exclusively breastfeeding.
To investigate if antenatal breastmilk expression affects rates of exclusive breastfeeding
Measured: From date of birth to 3 weeks post partum.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2025
- Study startSep 2026 (estimated)
- Primary completionJan 2029 (estimated)
- Study completionJul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preterm BirthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Odense University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Aabenraa Hospital, Esbjerg Hospital - University Hospital of Southern Denmark, Kolding Sygehus, University of Aarhus
- Responsible party
- Sponsor
- Investigators
- Gitte Zachariassen, MD, phd, Study chair, The Hans Christian Andersen Children's Hospital, Odense University HospitalChristina A Vinter, MD, phd, Study chair, The Department of Gynaecology and Obstetrics, Odense University HospitalLeonora S Borum, MD, Principal investigator, The Hans Christian Andersen Children's Hospital, Odense University HospitalSarah B Bentzen, Midwife, Principal investigator, The Hans Christian Andersen Children's Hospital, Odense University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07191366
- Sponsor's protocol ID
- OUH-HCA042
- Acronym
- EXPRESSMOM2
- Status last verified
- Aug 2025
- First submitted
- 1 Sep 2025
- Last updated
- 24 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No