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The Savella Pregnancy Registry (SPR)

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ClinicalTrials.gov Identifier: NCT01026077
Recruitment Status : Recruiting
First Posted : December 4, 2009
Last Update Posted : October 27, 2022
Information provided by (Responsible Party):
Syneos Health

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.

Condition or disease

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.

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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
Actual Study Start Date : November 2009
Estimated Primary Completion Date : June 2023
Estimated Study Completion Date : June 2023

Resource links provided by the National Library of Medicine

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

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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Women who are exposed to Savella during pregnancy.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01026077

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

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United States, North Carolina
Syneos Health Recruiting
Wilmington, North Carolina, United States, 28403
Contact    877-643-3010    pregnancyregistries@syneoshealth.com   
Sponsors and Collaborators
Syneos Health
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Principal Investigator: Sara Ephross, PhD Sr. Advisor, Epidemiology & Health Outcomes
Additional Information:
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Responsible Party: Syneos Health
ClinicalTrials.gov Identifier: NCT01026077    
Other Study ID Numbers: MLN-MD-30
First Posted: December 4, 2009    Key Record Dates
Last Update Posted: October 27, 2022
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Syneos Health:
Savella pregnant
savella pregnancy
fibromyalgia pregnant
fibromyalgia pregnancy
pregnancy registry savella
Additional relevant MeSH terms:
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Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases