PRenatal Video-Based Education and PostPARtum Effects

Breastfeeding Clinical Trial

— PREPARE  

Official title:

Effect of Antenatal Milk Expression on Breastfeeding Outcomes Among Overweight and Obese Women

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04258709
• Other study ID #: STUDY19030116
• Secondary ID: R01HD098186
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 31, 2020
• Est. completion date: March 1, 2025

Study information

• Verified date: April 2024
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 280
• Est. completion date: March 1, 2025
• Est. primary completion date: December 13, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Breastfeeding

Intervention

Behavioral:
• AME
Participants receive education on AME and feedback on technique with a remotely-based IBCLC via live streaming video.
• Video-based infant care education
Participants view a standard set of web-based streamed videos addressing evidence-based infant care, unrelated to feeding/breastfeeding.

Locations

Country	Name	City	State
United States	University of Pittsburgh	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pittsburgh	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Breastfeeding exclusivity	current provision of only breast milk feeds	2 weeks postpartum
Primary	Breastfeeding self-efficacy	Score on Breastfeeding Self-Efficacy Scale-SF (score range 14-70, with higher score represents better outcome)	2 weeks postpartum
Secondary	Breastfeeding exclusivity (dichotomous)	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
Secondary	Breastfeeding exclusivity (categorical)	Categorical outcome indicating proportional range of breast milk feeds since infant was born	2 weeks
Secondary	Breastfeeding exclusivity (categorical)	Categorical outcome indicating proportional range of breast milk feeds during postpartum/birth hospitalization (0-4 days postpartum)	0-4 days postpartum
Secondary	Breastfeeding exclusivity (categorical)	Categorical outcome indicating proportional range of breast milk feeds in past week	6 weeks, 12 weeks, 6 months postpartum
Secondary	Breastfeeding duration	Current provision of any breast milk	Postpartum hospitalization (0-4 days postpartum), postpartum weeks 2, 6, 12; 6 and 12 months postpartum
Secondary	Breastfeeding self-efficacy	Scores on Breastfeeding Self-Efficacy Scale-SF(score range 14-70, with higher score represents better outcome)	Postpartum weeks 6 and 12
Secondary	Onset of lactogenesis II	Recall of lactogenesis II in post-birth days	2 weeks postpartum
Secondary	Perceived milk supply (continuous)	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
Secondary	Perceived milk supply (dichotomous)	Endorsement of insufficient milk supply via investigator created item (dichotomous outcome)	2, 6, and 12 weeks postpartum
Secondary	Experiences with and perceptions of AME	Qualitative assessment via interviews with a subset of participants	6 weeks postpartum