"Drugs in Lactation" Analysis Consortium

NCT02755194 | Terminated

• 1 other identifier: 1000036538
• Study Type: observational
• Target: 68
• Locations: 1 country
• Sites: 1

Brief Summary

Some medications taken by the breastfeeding women are excreted into milk, posing a potential risk of toxicity to the infant. The first line of evidence required for toxicity risk assessment is prediction of drug levels in milk. However, pharmacokinetic (PK) information of drug excretion into milk is largely lacking, or limited to data from case reports. This makes it difficult to provide population-level prediction of drug levels in milk. The lack of data on this topic jeopardizes not only maternal adherence to drug therapy during breastfeeding but also establishment of breastfeeding, even if the drug is considered safe during nursing. Clearly, this clinical problem in drug safety is an important women's health issue, affecting both mother and infant. "Drugs in Lactation" Analysis Consortium (DLAC) is a "drug-in-milk" monitoring network, which is designed as a platform for efficient collection of patient milk samples in a real world setting to generate population predictions of drug excretion levels into human milk.

Conditions

Lactation

Keywords

pharmacokinetics; Drug-in-milk; breastfeeding; drug safety; population pharmacokinetics

Outcome Measures

Primary Outcomes (1)

• Drug levels in breast milk

  Robust parameter estimates from pop PK modelling usually require samples from \>30-50 individuals. Therefore, an average of 4 years is considered as the time frame, so that the required numbers of samples for each drug can be collected for population PK analysis and modelling.

  Through the study completion, an average of 4 years

Study Arms (1)

Breastfeeding women on the study medications

The study population consists of lactating/breastfeeding women over the age of 18, who are able to communicate in English and are taking one or more of the study drugs (Infliximab, Adalimumab, Golimumab, Certolizumab, Etanercept, Methotrexate, Ezetimibe, Bupropion, Citalopram, Venlafaxine)

Other: No intervention

Interventions

No intervention OTHER

This is an observational study. The exposure of interest includes taking specific prescribed medications during breastfeeding.

Breastfeeding women on the study medications

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Lactating women over the age of 18 who are taking one of the drugs of interest of the study

You may qualify if:

• Age over 18 years old Taking one or more drugs of interest of the study, at steady state

You may not qualify if:

• Being unable to communicate in English, Colostrum phase (\<1 week postpartum)

Sponsors & Collaborators

• The Hospital for Sick Children: lead

Study Sites (1)

The Hospital for Sick Children

Toronto, Ontario, M5G1X8, Canada

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Breast milk samples are collected at different time-points before and after taking the medication.

MeSH Terms

Conditions

Breast Feeding

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior

Study Officials

• Shinya Ito, MD, FRCPC

  The Hospital for Sick Children

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Division Head, Senior Scientist

Study Record Dates

• First Submitted: April 21, 2016
• First Posted: April 28, 2016
• Study Start: September 1, 2014
• Primary Completion: September 25, 2019
• Study Completion: September 25, 2019
• Last Updated: October 22, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)