Ignite Creation Date:
2024-05-06 @ 4:14 PM
Last Modification Date:
2024-10-26 @ 2:07 PM
Study NCT ID:
NCT04929301
Status:
COMPLETED
Last Update Posted:
2021-06-18
First Post:
2021-05-11
Brief Title:
Antenatal Milk Expression in Nulliparous Pregnant People
Sponsor:
University of Pittsburgh
Organization:
University of Pittsburgh
Study Overview
Official Title:
Feasibility and Acceptability of Antenatal Breast Milk Expression-a Pilot Randomized Trial in Nulliparous Pregnant People
Status:
COMPLETED
Status Verified Date:
2021-06
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:
None
Brief Summary:
This was a pilot randomized trial to examine the feasibility and preliminary effectiveness of a structured antenatal milk expression AME educational intervention on breastfeeding outcomes within a sample of low-risk pregnant individuals without other children A convenience sample of 45 participants were enrolled and randomized to either the AME intervention or a control group receiving breastfeeding educational handouts Both groups met with study staff at 37 38 39 and 40 weeks gestation to receive assigned intervention AME participants practiced AME 1-2 timesday and recorded this in a diary Data were collected from surveys interviews and electronic health record to 3-4 months postpartum
Detailed Description:
Antenatal milk expression AME has emerged as a simple inexpensive novel method to increase maternal breastfeeding confidence avoid early formula use and increase proportion of mothers own milk MOM feeds-potentially leading to greater breastfeeding satisfaction increased breastfeeding duration and exclusivity and improved maternal-infant health outcomes AME capitalizes on the production and sometimes leaking of milk-commencing during the second trimester of pregnancy by allowing women to collect and store milk for later use if needed and gain confidence in breastfeeding and their milk-making capabilities AME may also prime the hormonal milk production process to create a larger postpartum milk supply Pilot studies conducted with diabetic women demonstrate AMEs safety feasibility and preliminary effectiveness in improving breastfeeding rates AME has yet to be investigated in non-diabetic populations
In the current study investigators trialed our study procedures and milk collection and analysis methods and examined the preliminary effectiveness of AME on breastfeeding outcomes among pregnant people without other biological children Forty-five healthy nulliparous women were enrolled and randomized to either a structured AME educational intervention or usual carecontrol group at Magee-Womens Hospital midwife practice at their 34-36 week prenatal appointment The Principal Investigator PI or an research assistant RA met with all participants weekly from 37 weeks until delivery during postpartum hospitalization and at 1-2 weeks and 3-4 months postpartum During visits the PIRA collected questionnaire data on maternal health and delivery stress depression as well as outcomes of perceived milk supply and breastfeeding attitude satisfaction confidence continuation and exclusivity Those randomized to AME were taught the technique at the 37 week visit by a lactation consultant with instructions to continue 1-2 timesday at home AME was practiced and reinforced with the lactation consultant at each subsequent visit Those in the control group received breastfeeding handouts at each prenatal visit For those in the AME group the PIRA also collected a small milk sample at each prenatal visit along with a written diary documenting AME at home The PIRA collected a milk sample from all participants at postpartum visits samples are stored at University of Pittsburgh School of Nursing lab for subsequent analyses TBD The PIRA conducted semi-structured interviews at 1-2 weeks postpartum with AME participants about their experiences with the intervention Summary statistics were then calculated for feasibility and breastfeeding outcome data with significance tests ANOVA chi-square to determine group differences breastfeeding outcomes as applicable Interview data were analyzed for major themes to refine the intervention for a larger trial
Data collected in this study were used to revise our AME clinical teaching protocol AME diaries and establish standard operating procedures for milk collection and storage for an ongoing larger randomized trial examining AMEs effect on breastfeeding outcomes
In the current study investigators trialed our study procedures and milk collection and analysis methods and examined the preliminary effectiveness of AME on breastfeeding outcomes among pregnant people without other biological children Forty-five healthy nulliparous women were enrolled and randomized to either a structured AME educational intervention or usual carecontrol group at Magee-Womens Hospital midwife practice at their 34-36 week prenatal appointment The Principal Investigator PI or an research assistant RA met with all participants weekly from 37 weeks until delivery during postpartum hospitalization and at 1-2 weeks and 3-4 months postpartum During visits the PIRA collected questionnaire data on maternal health and delivery stress depression as well as outcomes of perceived milk supply and breastfeeding attitude satisfaction confidence continuation and exclusivity Those randomized to AME were taught the technique at the 37 week visit by a lactation consultant with instructions to continue 1-2 timesday at home AME was practiced and reinforced with the lactation consultant at each subsequent visit Those in the control group received breastfeeding handouts at each prenatal visit For those in the AME group the PIRA also collected a small milk sample at each prenatal visit along with a written diary documenting AME at home The PIRA collected a milk sample from all participants at postpartum visits samples are stored at University of Pittsburgh School of Nursing lab for subsequent analyses TBD The PIRA conducted semi-structured interviews at 1-2 weeks postpartum with AME participants about their experiences with the intervention Summary statistics were then calculated for feasibility and breastfeeding outcome data with significance tests ANOVA chi-square to determine group differences breastfeeding outcomes as applicable Interview data were analyzed for major themes to refine the intervention for a larger trial
Data collected in this study were used to revise our AME clinical teaching protocol AME diaries and establish standard operating procedures for milk collection and storage for an ongoing larger randomized trial examining AMEs effect on breastfeeding outcomes
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