- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01026077
The Savella Pregnancy Registry (SPR)
November 20, 2023 updated by: Syneos Health
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.
Study Overview
Status
Recruiting
Conditions
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 Type
Observational
Enrollment (Estimated)
350
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Savella Pregnancy Registry associate
- Phone Number: 877-643-3010
- Email: pregnancyregistries@syneoshealth.com
Study Locations
-
-
North Carolina
-
Raleigh, North Carolina, United States, 27560
- Recruiting
- Syneos Health
-
Contact:
- Phone Number: 877-643-3010
- Email: pregnancyregistries@syneoshealth.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Sampling Method
Probability Sample
Study Population
Women who are exposed to Savella during pregnancy.
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
Fibromyalgia/prospective pregnancies
Women taking Savella during pregnancy.
Register prospectively, provide verbal consent.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
January 2017
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Estimate the prevalence of spontaneous abortions, stillbirths, induced abortions, minor congenital anomalies, and adverse pregnancy outcomes.
Time Frame: January 2017
|
January 2017
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Sara Ephross, PhD, Sr. Advisor, Epidemiology & Health Outcomes
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 1, 2009
Primary Completion (Estimated)
June 1, 2025
Study Completion (Estimated)
June 1, 2025
Study Registration Dates
First Submitted
December 3, 2009
First Submitted That Met QC Criteria
December 3, 2009
First Posted (Estimated)
December 4, 2009
Study Record Updates
Last Update Posted (Actual)
November 21, 2023
Last Update Submitted That Met QC Criteria
November 20, 2023
Last Verified
November 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- MLN-MD-30
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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