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Betaseron Pregnancy Registry

NCT ID: NCT00317564

Last Updated: 2018-12-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

113 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-04-30

Study Completion Date

2012-06-30

Brief Summary

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This is a prospective, observational, registration and follow-up study of women exposed to Betaseron® at the time of conception (i.e., any time from the first day of the last menstrual period) and/or during pregnancy. The Betaseron® Pregnancy Registry is designed to determine whether there is an increased risk or a pattern of birth defects in the offspring of women exposed to Betaseron® at conception and during pregnancy compared to rates from women in the general US population. Secondarily, the Registry will examine rates of spontaneous abortions and other negative pregnancy outcomes in this population. This study will be conducted in the United States (US). The Betaseron® Pregnancy Registry is sponsored by Bayer HealthCare Pharmaceuticals and is managed by the Post Approval \& Strategic Services group at INC Research, LLC. The scientific conduct and analysis of the Registry will be overseen by an Independent Data Safety Monitoring Board (IDSMB) consisting of external specialists in teratology, epidemiology, maternal and fetal medicine, and neurology (external member details available upon request).

Detailed Description

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Because informed consent is required, the Registration process must be initiated by the patient. An HCP who contacts the Registry may request an authorization for release of medical information packet or have the eligible patient contact the Registry directly. Once an eligible subject provides consent and permission to obtain information from her HCP, the Registry will contact the obstetric HCP and obtain information on demographics, history of previous pregnancies, maternal risk factors, pregnancy outcome, and neonatal health. Data will be collected from the maternal HCP at enrollment, during the second trimester (around week 20), and at outcome. Data on live born infants will be collected from the pediatrician at 4 months of age. If a birth defect is reported, targeted follow-up may be conducted.

NOTE: This study has previously been posted by Berlex, Inc. which has since been renamed to Bayer HealthCare Pharmaceuticals, Inc. Bayer HealthCare Pharmaceuticals, Inc. is the sponsor of this pregnancy registry.

Conditions

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Birth Defects Pregnancy Complications Multiple Sclerosis

Keywords

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Birth Defects High Risk Pregnancy Multiple Sclerosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

The subjects must meet the following criteria for registration:

* Enroll prospectively (patient is still pregnant and no structural defects have been noted on a prenatal test)
* Diagnosed with MS prior to or during the current pregnancy
* Exposed to Betaseron® on or after the first day of the patient's last menstrual period
* Provide verbal consent to participate in the Registry
* Verbally provide contact information for herself, her HCP, and the infant's HCP (as applicable)
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Bayer

INDUSTRY

Sponsor Role collaborator

Syneos Health

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jessica Albano, PhD, MS

Role: PRINCIPAL_INVESTIGATOR

Syneos Health

Vicki Poon, MPH

Role: STUDY_DIRECTOR

Bayer

Mark Rametta, D.O., FACOI, FACP

Role: STUDY_DIRECTOR

Bayer

Karen Maloney Marini

Role: STUDY_DIRECTOR

Bayer

Locations

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INC Research

Wilmington, North Carolina, United States

Site Status

Countries

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United States

References

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Coyle PK, Sinclair SM, Scheuerle AE, Thorp JM Jr, Albano JD, Rametta MJ. Final results from the Betaseron (interferon beta-1b) Pregnancy Registry: a prospective observational study of birth defects and pregnancy-related adverse events. BMJ Open. 2014 May 12;4(5):e004536. doi: 10.1136/bmjopen-2013-004536.

Reference Type DERIVED
PMID: 24821713 (View on PubMed)

Other Identifiers

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308740

Identifier Type: -

Identifier Source: org_study_id