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The Savella Pregnancy Registry

NCT01026077 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 350

Last updated 2025-01-08

No results posted yet for this study

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.

Conditions

  • Fibromyalgia

Sponsors & Collaborators

Principal Investigators

  • Sara Ephross, PhD · Sr. Advisor, Epidemiology & Health Outcomes

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-11-30
Primary Completion
2024-10-09
Completion
2024-10-09

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01026077 on ClinicalTrials.gov