Antenatal Milk Expression in Nulliparous Pregnant People

NCT04929301 | Completed

• 1 other identifier: STUDY20040354
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Pregnancy Related; Breast Feeding; Milk Expression, Breast

Outcome Measures

Primary Outcomes (2)

• Proportion of individuals randomized

  Number of individuals randomized divided by number of individuals screened

  End date for study recruitment (approximately one year after beginning enrollment)

• Proportion of participants completing study

  Number of participants completing final study survey divided by number enrolled

  End date for study data collection (approximately one year after beginning enrollment)

Secondary Outcomes (9)

• Breastfeeding confidence

  Enrollment, postpartum hospitalization: an average of 1-3 days postpartum, 1-2 weeks postpartum, 3-4 months postpartum

• Perceived milk supply (single item)

  During postpartum hospitalization: an average of 1-3 days postpartum, 1-2 weeks postpartum, 3-4 months postpartum

• Perceived milk supply (scale score)

  During postpartum hospitalization: an average of 1-3 days postpartum, 1-2 weeks postpartum, 3-4 months postpartum

• In-hospital formula use

  Discharge from birth hospital: an average of 1-3 days postpartum

• Breastfeeding continuation

  1-2 weeks postpartum, 3-4 months postpartum

Study Arms (2)

AME Hand-Expression

EXPERIMENTAL

Participants in the antenatal milk expression (AME) group will learn hand-expression from a certified lactation consultant beginning at 37 weeks of pregnancy. At the same visit, the PI or RA will also provide oral and written instructions for AME at home, specifically instructing participants to do AME 1-2 times per day for no longer than 10 minutes.

Other: Antenatal milk expression

Education

ACTIVE COMPARATOR

Participants in the education group will receive a weekly educational hand-out on varying breastfeeding topics (e.g., latch).

Other: Education handouts

Interventions

Antenatal milk expression OTHER

Hand-expression of breast milk in pregnancy

AME Hand-Expression

Education handouts OTHER

Educational breastfeeding handouts

Education

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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).
• Conditions known to significantly adversely impact maternal milk supply (e.g., breast hypoplasia, history of breast reduction surgery, as assessed on screening form)
• 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

Sponsors & Collaborators

• University of Pittsburgh: lead
• American Nurses Foundation: collaborator

Study Sites (1)

UPMC Magee Women's Hospital

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (1)

• 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.

  PMID: 35799299 DERIVED

MeSH Terms

Conditions

Breast Feeding; Breast Milk Expression

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior

Study Officials

• Jill R Demirci, PhD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 11, 2021
• First Posted: June 18, 2021
• Study Start: November 21, 2016
• Primary Completion: July 9, 2018
• Study Completion: July 9, 2018
• Last Updated: June 18, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)