- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04258709
PRenatal Video-Based Education and PostPARtum Effects (PREPARE)
Effect of Antenatal Milk Expression on Breastfeeding Outcomes Among Overweight and Obese Women
The purpose of this randomized controlled trial is to examine the impact of a remotely-delivered antenatal milk expression (AME) intervention versus an attention control condition on breastfeeding outcomes among a sample of 280 nulliparous, non-diabetic women with pre-pregnancy body mass indices ≥ 25. AME involves milk expression and collection in the third pregnancy trimester and is theorized to address multiple barriers to breastfeeding among women with higher BMI, including impaired breastfeeding self-efficacy, insufficient milk supply (critical period endocrine modulation of milk volume), and early formula supplementation in the context of a medically complex birth (availability of banked antenatal milk).
Participants will be enrolled in their third trimester of pregnancy and allocated into one of two study arms: 1) AME instruction delivered by remote, live International Board Certified Lactation Consultants via an innovative app-based telelactation platform; or 2) an attention control condition (video-based infant care education unrelated to infant feeding). Video-based education for both groups will occur in weekly study visits from 37 to 40 weeks gestation, with women in the intervention group continuing AME 1-2 times per day at home.
Measured outcomes of interest will include short and long-term breastfeeding practices (e.g., breastfeeding duration, exclusivity) and participants' experiences with and perceptions of AME.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The purpose of the PREPARE Trial is to examine the impact of an antenatal milk expression (AME) intervention among women with pre-pregnancy BMI 25 or more on breastfeeding outcomes, including breastfeeding self-efficacy, breastfeeding duration and exclusivity, and perception of insufficient milk supply. Specifically, the investigators will:
- Determine the effect of the AME intervention on short-term breastfeeding outcomes, including breastfeeding self-efficacy and exclusivity, to two weeks postpartum.
- Explore the sustained effect of the AME intervention on longer-term breastfeeding duration and exclusivity over the first year postpartum.
- Examine participants' experiences with and perceptions of AME.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Melissa Glasser, PhD
- Phone Number: 412-624-6997
- Email: mlg130@pitt.edu
Study Contact Backup
- Name: Jill Demirci, PhD
- Phone Number: 412-648-9236
- Email: jvr5@pitt.edu
Study Locations
-
-
Pennsylvania
-
Pittsburgh, Pennsylvania, United States, 15213
- University of Pittsburgh
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Pregnant women who:
- have a pre-pregnancy BMI ≥ 25
- are ≥ 18 years
- are English-speaking
- are 34 0/7-36 6/7 gestational weeks
- are nulliparous
- intend to/have interest in breastfeeding after birth
- are having a singleton pregnancy
- plan to receive prenatal care and deliver at select hospital/birth facility systems (access to EMR data)
Exclusion Criteria:
- contraindications to breastfeeding as specified by the American Academy of Pediatrics
- history of breast reduction surgery or radiation
- indication for delivery by 37 weeks gestation
- gestational or pre-existing diabetes
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Antenatal Milk Expression (AME) Intervention Group
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.
|
Participants receive education on AME and feedback on technique with a remotely-based IBCLC via live streaming video.
|
Active Comparator: Video-based Infant Care Education Control Group
Weekly video education (weeks 37-40 of pregnancy) on various topics related to infant care (e.g., safe sleep, car seat safety, etc.).
|
Participants view a standard set of web-based streamed videos addressing evidence-based infant care, unrelated to feeding/breastfeeding.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Breastfeeding exclusivity
Time Frame: 2 weeks postpartum
|
current provision of only breast milk feeds
|
2 weeks postpartum
|
Breastfeeding self-efficacy
Time Frame: 2 weeks postpartum
|
Score on Breastfeeding Self-Efficacy Scale-SF (score range 14-70, with higher score represents better outcome)
|
2 weeks postpartum
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Breastfeeding exclusivity (dichotomous)
Time Frame: Postpartum hospitalization (0-4 days postpartum), 2 weeks, 6 weeks, 12 weeks, 6 months postpartum
|
Dichotomous outcome of current provision of only breast milk feeds
|
Postpartum hospitalization (0-4 days postpartum), 2 weeks, 6 weeks, 12 weeks, 6 months postpartum
|
Breastfeeding exclusivity (categorical)
Time Frame: 2 weeks
|
Categorical outcome indicating proportional range of breast milk feeds since infant was born
|
2 weeks
|
Breastfeeding exclusivity (categorical)
Time Frame: 0-4 days postpartum
|
Categorical outcome indicating proportional range of breast milk feeds during postpartum/birth hospitalization (0-4 days postpartum)
|
0-4 days postpartum
|
Breastfeeding exclusivity (categorical)
Time Frame: 6 weeks, 12 weeks, 6 months postpartum
|
Categorical outcome indicating proportional range of breast milk feeds in past week
|
6 weeks, 12 weeks, 6 months postpartum
|
Breastfeeding duration
Time Frame: Postpartum hospitalization (0-4 days postpartum), postpartum weeks 2, 6, 12; 6 and 12 months postpartum
|
Current provision of any breast milk
|
Postpartum hospitalization (0-4 days postpartum), postpartum weeks 2, 6, 12; 6 and 12 months postpartum
|
Breastfeeding self-efficacy
Time Frame: Postpartum weeks 6 and 12
|
Scores on Breastfeeding Self-Efficacy Scale-SF(score range 14-70, with higher score represents better outcome)
|
Postpartum weeks 6 and 12
|
Onset of lactogenesis II
Time Frame: 2 weeks postpartum
|
Recall of lactogenesis II in post-birth days
|
2 weeks postpartum
|
Perceived milk supply (continuous)
Time Frame: 2, 6, and 12 weeks postpartum
|
Score on PIBBS subscale of H & H Lactation Scale measuring perceived infant satisfaction with breast milk received (score range: 5-35, higher score is better outcome)
|
2, 6, and 12 weeks postpartum
|
Perceived milk supply (dichotomous)
Time Frame: 2, 6, and 12 weeks postpartum
|
Endorsement of insufficient milk supply via investigator created item (dichotomous outcome)
|
2, 6, and 12 weeks postpartum
|
Experiences with and perceptions of AME
Time Frame: 6 weeks postpartum
|
Qualitative assessment via interviews with a subset of participants
|
6 weeks postpartum
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Jill Demirci, PhD, University of Pittsburgh
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- STUDY19030116
- R01HD098186 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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