RECRUITING

A Study to Assess Pregnancy Outcomes in Women Exposed to Diroximel Fumarate

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The primary objective of the study is to estimate the prevalence of major congenital malformations (MCMs) and compare the prevalence between the diroximel fumarate (DRF) and comparator groups. The secondary objectives of the study are to estimate the incidence of spontaneous abortion (SA) and compare the incidence between the DRF and comparator groups; to estimate the incidence of preterm birth and compare the incidence between the DRF and comparator groups; to estimate the incidence of stillbirth and compare the incidence between the DRF and comparator groups and to estimate the prevalence of small for gestational age (SGA) and compare the prevalence between the DRF and comparator groups.

Official Title

Pregnancy Outcomes in Women Exposed to Diroximel Fumarate

Quick Facts

Study Start:2021-09-24
Study Completion:2031-01-17
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05688436

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 49 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * Last menstrual period (LMP) between 29 October 2019 and 31 July 2030.
  2. * Continuous medical and pharmacy coverage for a minimum of 6 months prior to and including the estimated LMP.
  3. * Presence of MS.
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

US Biogen Clinical Trial Center
CONTACT
866-633-4636
clinicaltrials@biogen.com
Global Biogen Clinical Trial Center
CONTACT
clinicaltrials@biogen.com

Principal Investigator

Medical Director
STUDY_DIRECTOR
Biogen

Study Locations (Sites)

OptumInsight
Eden Prairie, Minnesota, 55344-2503
United States

Collaborators and Investigators

Sponsor: Biogen

  • Medical Director, STUDY_DIRECTOR, Biogen

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-09-24
Study Completion Date2031-01-17

Study Record Updates

Study Start Date2021-09-24
Study Completion Date2031-01-17

Terms related to this study

Keywords Provided by Researchers

  • Pregnancy
  • Relapsing forms of Multiple Sclerosis (MS)

Additional Relevant MeSH Terms

  • Multiple Sclerosis