The Savella Pregnancy Registry

NCT ID: NCT01026077

Last Updated: 2025-01-08

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 350 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2009-11-30
• Study Completion Date: 2024-10-09

Brief Summary

The Savella Pregnancy Registry is a US based registry designed to monitor pregnancies exposed to Savella (milnacipran HCI). This is an observational, exposure-registration and follow-up registry designed primarily to estimate the prevalence of major congenital anomalies, and secondarily to estimate the prevalence of recognized spontaneous abortions, stillbirths, induced abortions, minor congenital anomalies, and any serious adverse pregnancy outcomes among pregnancies exposed to Savella as well as adverse outcomes observed during the first year of life in off-springs born from these exposed pregnancies. Live offspring are followed from birth until age one. The Savella Pregnancy Registry is sponsored by AbbVie (formerly Actavis PLC, Forest Laboratories Inc., and Allergan) and managed by Syneos Health.

Detailed Description

Registry enrollment is voluntary and initiated by pregnant patients or their healthcare providers (HCP). Patient-initiated reports must be verified by the HCP. Enrollment should occur as early in pregnancy as possible, preferably before any prenatal testing has occurred; however, enrollment at any time during pregnancy is allowed. Near the estimated date of delivery, the Registry prompts the HCP to provide pregnancy outcome data. If a live birth is reported, the Registry conducts follow-up with the infant's HCP at outcome, 4 months, and 12 months of age. If a birth defect is indicated, the Registry requests additional targeted follow-up information from the HCP. Data are collected on exposure to Savella, potential confounding factors, pregnancy outcome, and pediatric outcome for all live born babies. Cases are reviewed and classified according to type of birth defects. Adverse event cases are forwarded to Allergan.

Conditions

Fibromyalgia

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Fibromyalgia/prospective pregnancies

Women taking Savella during pregnancy. Register prospectively, provide verbal consent.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Females exposed to Savella during pregnancy
• Willing to provide verbal consent
• 18 y/o, US citizen

Exclusion Criteria

• Male
• Under 18 y/o
• Females not pregnant, not exposed to Savella

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

AbbVie

INDUSTRY

Sponsor Role: collaborator

Syneos Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sara Ephross, PhD

Role: PRINCIPAL_INVESTIGATOR

Sr. Advisor, Epidemiology & Health Outcomes

Locations

Syneos Health

Raleigh, North Carolina, United States

Countries

United States

Other Identifiers

MLN-MD-30

Identifier Type: -

Identifier Source: org_study_id