Clinical trial NCT01026077: The Savella Pregnancy Registry
Official title: The Savella Pregnancy Registry
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Fibromyalgia
Keywords: Savella pregnant
savella pregnancy
fibromyalgia pregnant
fibromyalgia pregnancy
pregnancy registry savella
Lead sponsor: Syneos Health
Sponsor class: OTHER
Collaborators: name: AbbVie
First posted: 2009-12-04
Enrollment: 350
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Women who are exposed to Savella during pregnancy.

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.

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.

Eligibility 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

Primary outcomes:
measure: The primary objective is to estimate the prevalence of major congenital anomalies among off-springs of women exposed to Savella during pregnancy.
timeFrame: January 2017
Secondary outcomes:
measure: Estimate the prevalence of spontaneous abortions, stillbirths, induced abortions, minor congenital anomalies, and adverse pregnancy outcomes.
timeFrame: January 2017
Other outcomes:
Locations:
city: Raleigh
country: United States
facility: Syneos Health
state: North Carolina
Study officials:
affiliation: Sr. Advisor, Epidemiology & Health Outcomes
name: Sara Ephross, PhD
role: PRINCIPAL_INVESTIGATOR
References: