The Savella Pregnancy Registry (SPR)

Study Description

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 Allergan (formerly Actavis PLC and Forest Laboratories Inc.) and managed by INC Research, LLC.

Condition or disease
Fibromyalgia

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.

Study Design

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Study Type :	Observational [Patient Registry]
Estimated Enrollment :	350 participants
Observational Model:	Cohort
Time Perspective:	Prospective
Target Follow-Up Duration:	1 Year
Official Title:	The Savella Pregnancy Registry
Study Start Date :	November 2009
Estimated Primary Completion Date :	December 2019
Estimated Study Completion Date :	December 2019

Groups and Cohorts

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort
Fibromyalgia/prospective pregnancies; Women taking Savella during pregnancy. Register prospectively, provide verbal consent.

Outcome Measures

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. The primary objective is to estimate the prevalence of major congenital anomalies among off-springs of women exposed to Savella during pregnancy. [ Time Frame: January 2017 ]

Secondary Outcome Measures :

1. Estimate the prevalence of spontaneous abortions, stillbirths, induced abortions, minor congenital anomalies, and adverse pregnancy outcomes. [ Time Frame: January 2017 ]

Eligibility Criteria

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes
Sampling Method:	Probability Sample

Study Population

Women who are exposed to Savella during pregnancy.

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

Contacts and Locations

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Contacts

Contact: Savella Pregnancy Registry associate	877-643-3010	pregnancyregistries@incresearch.com

Locations

United States, North Carolina
INC Research	Recruiting
Wilmington, North Carolina, United States, 28405
Contact 877-643-3010 pregnancyregistries@incresearch.com

Sponsors and Collaborators

INC Research

Allergan

Investigators

Principal Investigator:	Susan Sinclair, RN, PhD	Sr. Epidemiologist

More Information

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:

Study and enrollment information for healthcare providers and patients 

Responsible Party:	INC Research
ClinicalTrials.gov Identifier:	NCT01026077 History of Changes
Other Study ID Numbers:	MLN-MD-30
First Posted:	December 4, 2009
Last Update Posted:	April 3, 2018
Last Verified:	April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No

Keywords provided by INC Research:

Savella pregnant; savella pregnancy; fibromyalgia pregnant; fibromyalgia pregnancy; pregnancy registry savella

Additional relevant MeSH terms:

Fibromyalgia; Myofascial Pain Syndromes; Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Milnacipran; Antidepressive Agents; Psychotropic Drugs	Serotonin Uptake Inhibitors; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Molecular Mechanisms of Pharmacological Action; Neurotransmitter Agents; Serotonin Agents; Physiological Effects of Drugs; Adrenergic Uptake Inhibitors; Adrenergic Agents