Ignite Creation Date:
2024-05-06 @ 2:14 PM
Last Modification Date:
2024-10-26 @ 1:27 PM
Study NCT ID:
NCT04258709
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-04-10
First Post:
2020-02-03
Brief Title:
PRenatal Video-Based Education and PostPARtum Effects
Sponsor:
University of Pittsburgh
Organization:
University of Pittsburgh
Study Overview
Official Title:
Effect of Antenatal Milk Expression on Breastfeeding Outcomes Among Overweight and Obese Women
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PREPARE
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 eg breastfeeding duration exclusivity and participants experiences with and perceptions of AME
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 eg breastfeeding duration exclusivity and participants experiences with and perceptions of AME
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01HD098186 | NIH | None | httpsreporternihgovquickSearchR01HD098186 |