Antenatal Milk Expression in Nulliparous Pregnant People

Completed · Not applicable

Conditions studied: Pregnancy Related, Breast Feeding, Milk Expression, Breast

In brief

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.

Key facts

Study ID

NCT04929301

Run by

University of Pittsburgh

People needed

45

Starts

2016-11-21

Expected to finish

2018-07-09

Last updated by the study team

2021-06-18

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• Pregnant with a single fetus
• 34-36 6/7 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

Where it is running

• UPMC Magee Women's Hospital — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

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