The Savella Pregnancy Registry
| Status: | Recruiting |
|---|---|
| Conditions: | Fibromyalgia, Pain |
| Therapuetic Areas: | Musculoskeletal, Rheumatology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/6/2019 |
| Start Date: | November 2009 |
| End Date: | December 2019 |
| Contact: | Savella Pregnancy Registry associate |
| Email: | pregnancyregistries@syneoshealth.com |
| Phone: | 877-643-3010 |
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 Syneos Health.
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 Syneos Health.
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.
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.
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
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