Clinical trial NCT04929301: Antenatal Milk Expression in Nulliparous Pregnant People
Official title: Feasibility and Acceptability of Antenatal Breast Milk Expression-a Pilot Randomized Trial in Nulliparous Pregnant People
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy Related
Breast Feeding
Milk Expression, Breast
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: American Nurses Foundation
First posted: 2021-06-18
Enrollment: 45
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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 times/day 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 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.

Eligibility criteria: Inclusion Criteria:

1. Pregnant with a single fetus
2. 34-36 6/7 weeks pregnant (calculated from anticipated due date)
3. No other living children and no prior breastfeeding experience
4. Plan to breastfeed exclusively for at least 4 months
5. At least 18 years old
6. Plan to deliver baby at Magee-Womens Hospital of UPMC
7. Healthy (no major medical or pregnancy condition which would constitute a high-risk pregnancy)

Exclusion Criteria:

1. Women with contraindications to breastfeeding, as specified by American Academy of Pediatrics, including HIV+ status, human T-cell lymphotrophic virus, etc. HIV status will be assessed by history (maternal self-report of diagnosis).
2. Conditions known to significantly adversely impact maternal milk supply (e.g., breast hypoplasia, history of breast reduction surgery, as assessed on screening form)
3. Conditions which predispose to preterm labor or otherwise constitute a high-risk pregnancy as outlined by the National Institute of Child Health and Human Development including: breech presentation, vaginal bleeding during second or third pregnancy trimester (more than one episode, not related to possible cervical mechanical trauma from sexual intercourse or cervical exam), diagnosed or suspected developmental abnormalities in the fetus, less than 6 months between last birth and the beginning of current pregnancy, placenta previa, diabetes type I or II or gestational diabetes, preeclampsia (or hypertension with proteinuria), smoking, alcohol use, or illicit drug use during pregnancy, oligohydramnios/polyhydramnios, any previous second or third trimester pregnancy loss/miscarriage

Primary outcomes:
measure: Proportion of individuals randomized
timeFrame: End date for study recruitment (approximately one year after beginning enrollment)
measure: Proportion of participants completing study
timeFrame: End date for study data collection (approximately one year after beginning enrollment)
Secondary outcomes:
measure: Breastfeeding confidence
timeFrame: Enrollment, postpartum hospitalization: an average of 1-3 days postpartum, 1-2 weeks postpartum, 3-4 months postpartum
measure: Perceived milk supply (single item)
timeFrame: During postpartum hospitalization: an average of 1-3 days postpartum, 1-2 weeks postpartum, 3-4 months postpartum
measure: Perceived milk supply (scale score)
timeFrame: During postpartum hospitalization: an average of 1-3 days postpartum, 1-2 weeks postpartum, 3-4 months postpartum
measure: In-hospital formula use
timeFrame: Discharge from birth hospital: an average of 1-3 days postpartum
measure: Breastfeeding continuation
timeFrame: 1-2 weeks postpartum, 3-4 months postpartum
measure: Breastfeeding exclusivity
timeFrame: 1-2 weeks postpartum, 3-4 months postpartum
measure: Promoters and barriers to antenatal milk collection and storage
timeFrame: 1-2 weeks postpartum
measure: Proportion of participants completing study visits
timeFrame: Study visits at 37, 38, 39, and 40 weeks of pregnancy
measure: Proportion of participants engaging in AME
timeFrame: End date for participant's pregnancy: an average of 40 gestational weeks with upper range to 42 gestational weeks
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: UPMC Magee Women's Hospital
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Jill R Demirci, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Demirci JR, Glasser M, Himes KP, Sereika SM. Structured antenatal milk expression education for nulliparous pregnant people: results of a pilot, randomized controlled trial in the United States. Int Breastfeed J. 2022 Jul 7;17(1):50. doi: 10.1186/s13006-022-00491-8.