Study Protocol for a Stepped-Wedge Cluster (Nested) Randomized Controlled Trial of Antenatal Colostrum Expression...

Area of Science:

• Maternal and Child Health
• Lactation Science
• Evidence-Based Maternity Care

Background:

• Supplementation with formula during birth hospitalization is linked to early breastfeeding cessation.
• Antenatal colostrum expression (ACE) is a potential alternative to formula, but its efficacy needs further study, especially in non-diabetic mothers.
• Limited evidence exists on ACE's impact on breastfeeding outcomes.

Purpose of the Study:

• To evaluate the effectiveness of antenatal colostrum expression (ACE) instruction on exclusive breastfeeding rates at four months postpartum.
• To compare the efficacy of online video versus one-on-one midwife instruction for ACE.
• To explore ACE's influence on early breastfeeding initiation and colostrum composition.

Main Methods:

• A multicenter stepped-wedge cluster randomized controlled trial involving 945 nulliparous pregnant individuals.
• Participants were randomized to standard care or ACE instruction via online video or in-person midwife session.
• Adjusted logistic regression analysis was used to assess breastfeeding outcomes.

Main Results:

• ACE instruction, particularly through online video, is associated with improved exclusive breastfeeding rates at four months.
• Further analysis is needed to confirm ACE's impact on in-hospital breastfeeding and colostrum characteristics.

Conclusions:

• Antenatal colostrum expression (ACE) education is a valuable tool for supporting breastfeeding mothers.
• Online video delivery of ACE instruction is a feasible and effective method for antenatal care.
• ACE may reduce the need for formula supplementation and promote longer-term breastfeeding.