Monitoring the development of breast tissue composition during pregnancy, lactation and involutio

Recruiting

Conditions: Borstsamenstelling tijdens zwangerschap, lactatie en post-lactatie
breastfeeding problems
lactation insufficiency

Registration Number: NL-OMON53278

Lead Sponsor: niversiteit Twente

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 10

Inclusion Criteria

• Women with a child wish OR in the first trimester of pregnancy
• Between 18 to 45 years
• >9 months postpartum & post breast feeding of previous pregnancy

Exclusion Criteria

• Breast augmentation, reduction, reconstruction or other procedures
• Breast tattoos or piercings
• Known breast disease at time of the experiment
• Pregnancy or breastfeeding < 9 months at the start of the study (due to
differing breast physiology)
• Not eligible for MRI, see F1. Vragenlijst Screening MRI. This includes having
a:
• Pacemaker
• Implantable cardioverter-defibrillator (ICD)
• Hearing implant
• Drug pump
• Neurostimulator

Study & Design

Study Type: Observational non invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>This study aims to map the spatiotemporal changes in the anatomical and<br /><br>physiological parameters of the human lactating breast from pregnancy to<br /><br>post-lactational involution. The main study parameters are the amount of<br /><br>glandular and adipose tissue of the breast and the blood content of the breast,<br /><br>as well as a one-time 24h milk production measurement 4 to 6 weeks postpartum.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>• Validate DOSI against MRI for measuring the amount of glandular and adipose<br /><br>tissue inside the breast<br /><br>• Evaluate the relation between (changes in) breast tissue composition and milk<br /><br>production<br /><br>• Define the duration of post-lactational involution<br /><br>• Compare breast tissue composition before pregnancy to after post-lactational<br /><br>involution</p><br>