NCT04929301

Antenatal Milk Expression in Nulliparous Pregnant People

Completed NA Last updated 18 June 2021

What this trial tests

NA trial testing Antenatal milk expression in Pregnancy Related in 45 participants. Completed in 9 July 2018.

Timeline

21 November 2016

Primary endpoint
9 July 2018

9 July 2018

Quick facts

Lead sponsor	University of Pittsburgh
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	supportive care
Enrollment	45
Start date	21 November 2016
Primary completion	9 July 2018
Estimated completion	9 July 2018
Sites	1 location across United States

Drugs / interventions tested

• Antenatal milk expression
• Education handouts

Conditions studied

• Pregnancy Related — all drugs for Pregnancy Related →
• Breast Feeding — all drugs for Breast Feeding →
• Milk Expression, Breast — all drugs for Milk Expression, Breast →

Sponsor

University of Pittsburgh

Who can join

18 and older, female only, with Pregnancy Related or Breast Feeding. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Structured antenatal milk expression education for nulliparous pregnant people: results of a pilot, randomized controlled trial in the United States.
   Demirci JR, Glasser M, Himes KP, Sereika SM. · · 2022 · cited 12× · PMID 35799299 · DOI 10.1186/s13006-022-00491-8
2. Structured Antenatal Milk Expression Education for Nulliparous Pregnant People: Results of a Pilot, Randomized Controlled Trial in The United States
   Demirci J, Glasser M, Himes KP, Sereika SM. · · 2021 · DOI 10.21203/rs.3.rs-853172/v1