Antenatal Milk Expression Education for Breastfeeding

(PREPARE Trial)

Overseen By Melissa Glasser, PhD

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: University of Pittsburgh

Disqualifiers: Breast surgery, Early delivery, Diabetes, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if teaching expectant mothers how to express milk before birth can improve breastfeeding success. It focuses on pregnant women with a higher body mass index (BMI ≥ 25), who often encounter challenges like low milk supply or early formula use. Participants will either receive remote lessons on antenatal milk expression (AME) or watch videos on infant care. Pregnant women who haven't given birth before and are interested in breastfeeding might be a good fit, especially if they are in their third trimester and have no diabetes.

As an unphased trial, this study offers a unique opportunity to contribute to research that could enhance breastfeeding outcomes for many mothers.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your healthcare provider.

What prior data suggests that antenatal milk expression is safe for breastfeeding?

Research has shown that antenatal milk expression (AME) is generally safe for pregnant women. In a previous study, starting AME at week 34 did not trigger early labor, and no negative effects were reported. Most women in the study expressed milk several times a week without issues. This suggests that AME is well-tolerated and does not pose significant risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about antenatal milk expression (AME) because it offers a proactive approach to breastfeeding preparation, potentially enhancing milk production before birth. Unlike traditional methods that focus on breastfeeding support post-delivery, AME involves weekly video interactions with lactation consultants, allowing expectant mothers to practice milk expression and collect any expressed milk during the final weeks of pregnancy. This method not only empowers mothers with hands-on skills but also aims to ease the early breastfeeding experience, potentially increasing breastfeeding success rates and boosting infant health from the start.

What evidence suggests that antenatal milk expression is effective for improving breastfeeding outcomes?

This trial will compare Antenatal Milk Expression (AME) with video-based infant care education. Studies have shown that expressing milk before birth, known as AME, can aid breastfeeding, particularly for women with higher body weight. Research indicates that AME can boost a mother's confidence in her ability to produce enough milk, addressing a common concern for new mothers. Early findings suggest that women using AME may achieve better breastfeeding success, even with conditions like diabetes. However, not all studies agree on its impact on the timing of milk production. Overall, AME is considered a promising method to support breastfeeding by addressing issues like low milk supply and the early need for formula. ^{4 6 7 8 9}

Who Is on the Research Team?

Jill Demirci, PhD

Principal Investigator

University of Pittsburgh

Are You a Good Fit for This Trial?

This trial is for first-time pregnant women with a BMI ≥ 25, interested in breastfeeding, between 34-36 weeks of pregnancy. They must plan to give birth at certain hospitals and speak English. Women with plans for early delivery, breast surgery history, or diabetes are excluded.

Inclusion Criteria

You plan to breastfeed or are interested in breastfeeding after giving birth.

I am between 34 and almost 37 weeks pregnant.

I plan to have my prenatal care and delivery at a specific hospital that shares electronic medical records.

Exclusion Criteria

I have diabetes that started before or during pregnancy.

I have had breast reduction surgery or radiation.

indication for delivery by 37 weeks gestation

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Antenatal Milk Expression (AME) Intervention

Weekly video interactions with lactation consultants to teach and reinforce antenatal milk expression, with at-home practice of hand expression and collection of expressed milk

4 weeks

4 visits (virtual)

Postpartum Follow-up

Participants are monitored for breastfeeding outcomes, including self-efficacy, exclusivity, and duration

12 months

What Are the Treatments Tested in This Trial?

Interventions

• AME
• Video-based infant care education

Trial Overview The study compares two groups: one learns antenatal milk expression (AME) via an app from lactation consultants; the other gets video-based infant care education not about feeding. The goal is to see if AME helps women with higher BMI overcome breastfeeding challenges.

How Is the Trial Designed?

Group I: Antenatal Milk Expression (AME) Intervention Group Experimental Treatment 1 Intervention

Weekly video interactions (weeks 37-40 of pregnancy) with International Board Certified Lactation Consultants (IBCLCs) to teach and reinforce antenatal milk expression. At-home practice of hand expression and collection of any expressed milk.

Group II: Video-based Infant Care Education Control Group Active Control 1 Intervention

Weekly video education (weeks 37-40 of pregnancy) on various topics related to infant care (e.g., safe sleep, car seat safety, etc.).

Who Is Running the Clinical Trial?

University of Pittsburgh

Lead Sponsor

Trials

1,820

Recruited

16,360,000+

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Trials

2,103

Recruited

2,760,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7971107/

Evaluating antenatal breastmilk expression outcomes Antenatal breastmilk expression (aBME) is recommended by some healthcare providers to improve lactation, breastfeeding, and newborn outcomes.

2. internationalbreastfeedingjournal.biomedcentral.com internationalbreastfeedingjournal.biomedcentral.com/articles/10.1186/s13006-021-00371-7

Evaluating antenatal breastmilk expression outcomes Antenatal breastmilk expression (aBME) is recommended by some healthcare providers to improve lactation, breastfeeding, and newborn outcomes.

3. sciencedirect.com sciencedirect.com/science/article/pii/S2772632023000508

How to promote exclusive breastfeeding with antenatal ... Antenatal milk expression improved breastfeeding rates among people with diabetes. Successful antenatal milk expression bolsters confidence in the adequacy of ...

4. europeanjournalofmidwifery.eu europeanjournalofmidwifery.eu/Women-s-bodily-experience-of-antenatal-breastmilk-expression-from-34-weeks-of-gestation,193601,0,2.html

Women's bodily experience of antenatal breastmilk ... This study examines the bodily experiences of healthy women performing antenatal breastmilk expression (aBME) from gestational week 34 until term

5. obgyn.onlinelibrary.wiley.com obgyn.onlinelibrary.wiley.com/doi/10.1111/ajo.13929

Does Antenatal Expressing Affect Onset of Lactogenesis for ... Our findings do not provide evidence that antenatal expressing hastens onset of lactation in women with diabetes in pregnancy.

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39748396/

Safety of antenatal breastmilk expression from week 34 ... The study found that antenatal breastmilk expression from week 34 did not induce preterm labor, and no adverse events were reported.

7. mhnpjournal.biomedcentral.com mhnpjournal.biomedcentral.com/articles/10.1186/s40748-024-00197-1

Safety of antenatal breastmilk expression from week 34 of ... Most of the women (82%) reported to have performed aBME at least 7 times per week, and 53% reported to have expressed 12 times or more per week ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10019405/

Effect of antenatal milk expression education on lactation ... This study evaluates if antenatal milk expression (AME) education, delivered via telelactation, improves lactation outcomes in people with BMI ...

9. clinicaltrials.gov clinicaltrials.gov/study/NCT04929301

Antenatal Milk Expression in Nulliparous Pregnant People Summary statistics were then calculated for feasibility and breastfeeding outcome data, with significance tests (ANOVA, chi-square) to determine group ...