← Back to Search

Antenatal Milk Expression Education for Breastfeeding (PREPARE Trial)

N/A

Waitlist Available

Led By Jill Demirci, PhD

Research Sponsored by University of Pittsburgh

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

are ≥ 18 years

are 34 0/7-36 6/7 gestational weeks

Must not have

gestational or pre-existing diabetes

history of breast reduction surgery or radiation

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 weeks, 12 weeks, 6 months postpartum

Awards & highlights

No Placebo-Only Group

Summary

This trial will examine the impact of a remotely-delivered antenatal milk expression intervention on breastfeeding outcomes among a sample of 280 nulliparous, non-diabetic women with pre-pregnancy body mass indices ≥ 25.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

There may be no direct side effects from the educational interventions themselves. However, AME could potentially lead to early labor or discomfort due to milk expression before birth.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am 18 years old or older.

Select...

I am between 34 and almost 37 weeks pregnant.

Select...

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

Select...

I speak English.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have diabetes that started before or during pregnancy.

Select...

I have had breast reduction surgery or radiation.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 weeks, 12 weeks, 6 months postpartum

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 weeks, 12 weeks, 6 months postpartum

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 weeks, 12 weeks, 6 months postpartum for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Breastfeeding exclusivity

Secondary study objectives

Breastfeeding duration

Breastfeeding exclusivity (categorical)

Breastfeeding exclusivity (dichotomous)

+5 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Antenatal Milk Expression (AME) Intervention GroupExperimental Treatment1 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 GroupActive Control1 Intervention

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

0 / 6Eligibility criteria met