An interventional study of Handstimulation of breast in Preterm Birth, PPROM and Preeclampsia, sponsored by Odense University Hospital. Not yet recruiting. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-09-24.
Sponsored by Odense University Hospital · Not applicable, Interventional, and Prevention
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.
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.
Exclusion Criteria:
Antenatal breastmilk expression and colostrum collection
Procedure: Handstimulation of breast
Hand stimulation of the breast
Also known as: aBME, Breastmilk expression
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
Time frame: From date of randomization at 28 weeks to 34 weeks of pregnancy until the date of birth. Up to 100 days.
Amount of available mothers own milk at birth
Availability of mothers own milk for the newborn infant after antenatal breastmilk expression in pregnancy
Time frame: At birth
Oxytocin levels
To compare oxytocin levels from performing antenatal breastmilk expression or not
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: Within the first 3 weeks of post-partum
Number of women exclusively breastfeeding.
To investigate if antenatal breastmilk expression affects rates of exclusive breastfeeding
Time frame: From date of birth to 3 weeks post partum.
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
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Odense University Hospital