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

ConditionsPreterm BirthPPROMPreeclampsiaPrevious Preterm Birth
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorOdense University Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Handstimulation of breast

    Procedure/Surgery

    Hand stimulation of the breast

Treatment groups

250 Participants
are divided into 2 treatment groups
Group A: Handstimulation of the breastsExperimental treatment 1 intervention
Group B: ControlNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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.

Secondary outcomes

1

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
2

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.
3

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
4

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.

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Odense University Hospital

Lead sponsor

Aabenraa Hospital

Collaborator

Esbjerg Hospital - University Hospital of Southern Denmark

Collaborator

Kolding Sygehus

Collaborator

University of Aarhus

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: