Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 4:15 PM
Ignite Modification Date:
2025-12-24 @ 4:15 PM
NCT ID:
NCT07191366
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 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.
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.
Study:
NCT07191366
Study Brief:
Protocol Section:
NCT07191366