Status:
NOT_YET_RECRUITING
Antenatal Breastmilk Expression in Pregnant Women at High Risk of Preterm Birth
Lead Sponsor:
Odense University Hospital
Collaborating Sponsors:
Aabenraa Hospital
Esbjerg Hospital - University Hospital of Southern Denmark
Conditions:
Preterm Birth
PPROM
Eligibility:
FEMALE
18+ years
Phase:
NA
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 acc...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2029
Estimated Enrollment :
250 Patients enrolled
Trial Details
Trial ID
NCT07191366
Start Date
September 1 2026
End Date
July 1 2029
Last Update
September 24 2025
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