Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

PRenatal Video-Based Education and PostPARtum Effects (PREPARE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04258709
Recruitment Status : Recruiting
First Posted : February 6, 2020
Last Update Posted : April 27, 2021
Sponsor:
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
Jill R. Demirci, PhD, RN, IBCLC, University of Pittsburgh

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Breastfeeding Behavioral: AME Behavioral: Video-based infant care education Not Applicable

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:

  1. Determine the effect of the AME intervention on short-term breastfeeding outcomes, including breastfeeding self-efficacy and exclusivity, to two weeks postpartum.
  2. Explore the sustained effect of the AME intervention on longer-term breastfeeding duration and exclusivity over the first year postpartum.
  3. Examine participants' experiences with and perceptions of AME.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 280 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Masking Description:

Statistician completing final analysis of data will be blinded to group assignment. An unbiased, third party will conduct qualitative interviews.

Participants, obstetric providers in recruitment clinics, and lactation consultant interventionists will be blinded to outcomes of interest.

Primary Purpose: Supportive Care
Official Title: Effect of Antenatal Milk Expression on Breastfeeding Outcomes Among Overweight and Obese Women
Actual Study Start Date : August 31, 2020
Estimated Primary Completion Date : January 1, 2024
Estimated Study Completion Date : January 1, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breastfeeding

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.
Behavioral: AME
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.).
Behavioral: Video-based infant care education
Participants view a standard set of web-based streamed videos addressing evidence-based infant care, unrelated to feeding/breastfeeding.




Primary Outcome Measures :
  1. Breastfeeding exclusivity [ Time Frame: 2 weeks postpartum ]
    current provision of only breast milk feeds

  2. 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)


Secondary Outcome Measures :
  1. 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

  2. Breastfeeding exclusivity (categorical) [ Time Frame: 2 weeks ]
    Categorical outcome indicating proportional range of breast milk feeds since infant was born

  3. 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)

  4. Breastfeeding exclusivity (categorical) [ Time Frame: 6 weeks, 12 weeks, 6 months postpartum ]
    Categorical outcome indicating proportional range of breast milk feeds in past week

  5. 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

  6. 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)

  7. Onset of lactogenesis II [ Time Frame: 2 weeks postpartum ]
    Recall of lactogenesis II in post-birth days

  8. 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)

  9. Perceived milk supply (dichotomous) [ Time Frame: 2, 6, and 12 weeks postpartum ]
    Endorsement of insufficient milk supply via investigator created item (dichotomous outcome)

  10. Experiences with and perceptions of AME [ Time Frame: 6 weeks postpartum ]
    Qualitative assessment via interviews with a subset of participants



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Pregnant women who:

    1. have a pre-pregnancy BMI ≥ 25
    2. are ≥ 18 years
    3. are English-speaking
    4. are 34 0/7-36 6/7 gestational weeks
    5. are nulliparous
    6. intend to/have interest in breastfeeding after birth
    7. are having a singleton pregnancy
    8. plan to receive prenatal care and deliver at select hospital/birth facility systems (access to EMR data)

Exclusion Criteria:

  1. contraindications to breastfeeding as specified by the American Academy of Pediatrics
  2. history of breast reduction surgery or radiation
  3. indication for delivery by 37 weeks gestation
  4. gestational or pre-existing diabetes

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04258709


Contacts
Layout table for location contacts
Contact: Melissa Glasser, PhD 412-624-6997 mlg130@pitt.edu
Contact: Jill Demirci, PhD 412-648-9236 jvr5@pitt.edu

Locations
Layout table for location information
United States, Pennsylvania
University of Pittsburgh Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Melissa Glasser, PhD    412-624-6997    mlg130@pitt.edu   
Contact: Jill Demirci, PhD    412-648-9236    jvr5@pitt.edu   
Principal Investigator: Jill Demirci, PhD         
Sponsors and Collaborators
University of Pittsburgh
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
Layout table for investigator information
Principal Investigator: Jill Demirci, PhD University of Pittsburgh
Layout table for additonal information
Responsible Party: Jill R. Demirci, PhD, RN, IBCLC, Assistant Professor, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT04258709    
Other Study ID Numbers: STUDY19030116
R01HD098186 ( U.S. NIH Grant/Contract )
First Posted: February 6, 2020    Key Record Dates
Last Update Posted: April 27, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Raw (subject level) and/or aggregate data will be shared with other investigators as requested after: 1) publication of main findings; 2) removal of identifiers that would permit linkages to individual research participants; and 3) removal of variables that could lead to deductive disclosure of the identity of individuals. Any individual requests for data sharing will be executed in collaboration with the University of Pittsburgh Institutional Review Board to ensure strict adherence to policies for protections of human subjects. In addition, at the conclusion of the study, de-identified data will be submitted to the National Institute of Child Health and Development (NICHD) Data Repository to ensure public availability.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Time Frame: At the conclusion of the study, after publication of main findings.
Access Criteria: Contact study investigator or NICHD for access to data repository.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jill R. Demirci, PhD, RN, IBCLC, University of Pittsburgh:
antenatal milk expression
antenatal colostrum