Antenatal Breastmilk Expression in Pregnant Women at High Risk of Preterm Birth (NCT07191366) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Antenatal Breastmilk Expression in Pregnant Women at High Risk of Preterm Birth
250 participantsStarted 2026-09
Plain-language 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.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of days from randomization to birth
Timeframe: From date of randomization at 28 weeks to 34 weeks of pregnancy until the date of birth. Up to 100 days.