UPMC Magee Women's Hospital
Pittsburgh, Pennsylvania, 15213, United States
NCT Number: NCT04929301
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 times/day and recorded this in a diary. Data were collected from surveys, interviews, and electronic health record to 3-4 months postpartum.
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Notify Me18 year and older
Female
Interventional
Not applicable
Pittsburgh, Pennsylvania, 15213, United States
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 mother's 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 AME's 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 care/control 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 PI/RA 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 times/day 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 PI/RA also collected a small milk sample at each prenatal visit, along with a written diary documenting AME at home. The PI/RA 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 PI/RA 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 AME's effect on breastfeeding outcomes.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Hand-expression of breast milk in pregnancy
Educational breastfeeding handouts
Time frame: End date for study recruitment (approximately one year after beginning enrollment)
Number of individuals randomized divided by number of individuals screened
Time frame: End date for study data collection (approximately one year after beginning enrollment)
Number of participants completing final study survey divided by number enrolled
Time frame: Enrollment, postpartum hospitalization: an average of 1-3 days postpartum, 1-2 weeks postpartum, 3-4 months postpartum
between group differences in Breastfeeding Self-Efficacy Scale-SF (short form) scores (score range 14-70 with higher scores indicative of higher self-efficacy)
Time frame: During postpartum hospitalization: an average of 1-3 days postpartum, 1-2 weeks postpartum, 3-4 months postpartum
Between group differences in perceived postpartum milk supply assessed as a single investigator-created item asking "Do you feel you make enough breast milk to satisfy your baby?" with answer options of "yes," "no," or "unsure" (no and unsure dichotomized to yes="no PIM" and no/unsure= "PIM")
Time frame: During postpartum hospitalization: an average of 1-3 days postpartum, 1-2 weeks postpartum, 3-4 months postpartum
Between group differences in perceived postpartum milk supply assessed as a combined score on both the Perceived Infant Breastfeeding Satiety and Maternal-Infant Breastfeeding Satisfaction subscales (10 items total) within the H&H Lactation Scale; possible scores range from 0-70, wherein lower scores represented lower breastfeeding satisfaction and lower confidence that one was making enough milk.
Time frame: Discharge from birth hospital: an average of 1-3 days postpartum
Between group differences in any formula feeds during birth hospitalization (yes/no) extracted from electronic health record
Time frame: 1-2 weeks postpartum, 3-4 months postpartum
Between group differences in any breastmilk feeds (yes/no)
Time frame: 1-2 weeks postpartum, 3-4 months postpartum
Between group differences in only breast milk feeds (100% breast milk-yes/no)
Time frame: 1-2 weeks postpartum
Qualitative interviews assessing participant perceptions related to collecting and storing antenatal milk
Time frame: Study visits at 37, 38, 39, and 40 weeks of pregnancy
Number of participants completing each study visit divided by number enrolled
Time frame: End date for participant's pregnancy: an average of 40 gestational weeks with upper range to 42 gestational weeks
Number of participants engaging in AME during study visits and/or independently as documented in AME diary, divided by number of participants assigned to AME
University of Pittsburgh
Other
Feasibility and Acceptability of Antenatal Breast Milk Expression-a Pilot Randomized Trial in Nulliparous Pregnant People
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