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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 weeks, 12 weeks, 6 months postpartum

Awards & highlights

PREPARE Trial 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.Check my eligibility

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.See study design

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.

PREPARE Trial Eligibility Criteria

Inclusion Criteria

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

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I am 18 years old or older.

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I am between 34 and almost 37 weeks pregnant.

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

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I speak English.

PREPARE Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Breastfeeding exclusivity

Secondary outcome measures

Breastfeeding duration

Breastfeeding exclusivity (categorical)

Breastfeeding exclusivity (dichotomous)

+5 more

PREPARE 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 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of PittsburghLead Sponsor

1,722 Previous Clinical Trials

16,342,656 Total Patients Enrolled

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

1,964 Previous Clinical Trials

2,674,450 Total Patients Enrolled

Jill Demirci, PhDPrincipal InvestigatorUniversity of Pittsburgh

1 Previous Clinical Trials

250 Total Patients Enrolled

Media Library

AME Clinical Trial Eligibility Overview. Trial Name: NCT04258709 — N/A

Breastfeeding Research Study Groups: Antenatal Milk Expression (AME) Intervention Group, Video-based Infant Care Education Control Group

Breastfeeding Clinical Trial 2023: AME Highlights & Side Effects. Trial Name: NCT04258709 — N/A

AME 2023 Treatment Timeline for Medical Study. Trial Name: NCT04258709 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any vacancies for prospective participants in this clinical trial?

"Confirmed. Data from clinicaltrials.gov states that this medical trial, which was first published on August 31st 2020, is actively seeking participants to enrol. The total number needed for the study stands at 280 and it will be conducted in a single site."

Answered by AI

Are there specific qualifications needed to participate in this research project?

"This investigation is actively recruiting 280 participants aged 18 to 45 who are currently breastfeeding. Eligibility criteria also requires them to be ≥ 18 years old, 34 0/7-36 6/7 weeks pregnant, nulliparous, carrying a singleton pregnancy, and with a pre-pregnancy BMI of at least 25."

Answered by AI

Are elderly individuals eligible for this clinical study?

"This medical trial is limited to applicants aged 18-45. For those younger than 18, 17 alternative studies are available while 26 exist for seniors over 65 years of age."

Answered by AI

How many individuals have registered for this medical experiment?

"Affirmative. According to the information housed on clinicaltrials.gov, this research project is currently enrolling volunteers; the trial was initially posted on August 31st 2020 and most recently updated on May 13th 2022. 280 participants are required at a single medical site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

PRenatal Video-Based Education and PostPARtum Effects

Jill R. Demirci, PhD, RN, IBCLC 2020. "PRenatal Video-Based Education and PostPARtum Effects". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04258709.