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| ID | Type | Description | Link |
|---|---|---|---|
| MED-EPI-NEU-0649 | Other Grant/Funding Number | AbbVie |
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Migraine is a common neurological disorder typically characterized by attacks of throbbing or pulsating headache on one side of the head of moderate to severe pain intensity. The purpose of this study is to evaluate fetal, maternal, and infant outcomes through 12 months of age among women exposed to Ubrelvy or Qulipta during pregnancy, as well as in 2 comparator groups.
Ubrelvy (ubrogepant) and Qulipta (atogepant) are approved drugs for the acute treatment of migraine in adults. Approximately 628 pregnant women with migraine exposed to Ubrelvy, 628 pregnant women with migraine exposed to Qulipta and 628 pregnant women with migraine in comparator group will be enrolled in this study in the United States.
Participants enrolled in the Ubrelvy-exposed group and Qulipta-exposed group will receive Ubrelvy and Qulipta respectively as prescribed by their physician.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ubrelvy-Exposed Women With Migraine | Pregnant women with migraine who took at least 1 dose of Ubrelvy, the exposure of interest, at any time during pregnancy as part of routine care. | ||
| Qulipta-Exposed Women With Migraine | Pregnant women with migraine who took at least 1 dose of Qulipta, the exposure of interest, at any time during pregnancy as part of routine care. | ||
| Ubrelvy/Qulipta-Unexposed Women With Migraine | Pregnant women with migraine who have never taken Ubrelvy and/or Qulipta, OR discontinued Ubrelvy 2 days prior or Qulipta 5 days prior to conception. |
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| Measure | Description | Time Frame |
|---|---|---|
| Major Congenital Malformations (MCMs) | An MCM is defined as any major structural or chromosomal defect in live born infants, stillbirths/fetal losses of any gestational age. | Up through the first 12 months of life |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Pregnant Participants Experiencing Spontaneous Abortion | Recognized spontaneous abortion (SAB): loss of an embryo/fetus due to natural causes prior to 20 weeks of gestation. | Up through the first 12 months of life |
| Percentage of Pregnant Participants Experiencing Stillbirth |
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Inclusion Criteria:
Within the United States or Canada.
Qualify as a prospective enrollment, defined as currently pregnant.
A diagnosis of migraine by the patient's health care provider (HCP).
Provide contact information for the participant and her and her infant(s)', if applicable, HCPs.
Authorize their HCP(s) to release maternal and infant medical information to the registry, upon request.
Provide sufficient information to confirm eligibility for 1 of following:
Exclusion Criteria:
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The study population consists of pregnant women, residing in the US and at least 18 years of age, and live born infants resulting from enrolled pregnancies. Participating women must meet eligibility criteria, including criteria for either the exposure or comparator group.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| EMPRESS Pregnancy Call Center | Contact | 833-782-7241 | empresspregnancyregistry@iqvia.com |
| Name | Affiliation | Role |
|---|---|---|
| ABBVIE INC. | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Iqvia /Id# 266904 | Recruiting | Durham | North Carolina | 27703-8426 | United States | |
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| Label | URL |
|---|---|
| Related Info | View source |
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| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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A fetal death occurring at 20 gestation weeks or greater, or if gestational age is unknown, a fetus weighing 350 g or more. |
| Up through the first 12 months of life |
| Percentage of Pregnant Participants With Elective Termination | Elective termination is voluntary interruption of pregnancy, including pregnancy termination that occurs electively, to preserve maternal health, or due to abnormalities. | Up through the first 12 months of life |
| Percentage of Pregnant Participants Experiencing Preeclampsia | Preeclampsia is the presence of hypertension on 2 occasions at least 4 hours apart after 20 weeks gestation (in a woman with a previously normal blood pressure) and proteinuria, or new-onset hypertension accompanied by thrombocytopenia, renal insufficiency, impaired liver function, pulmonary edema, or cerebral or visual symptoms. | Up through the first 12 months of life |
| Percentage of Pregnant Participants Experiencing Eclampsia | Eclampsia is defined as new-onset seizures (tonic-clonic, focal, or multifocal) in the absence of other causative conditions such as epilepsy, cerebral arterial ischemia and infarction, intracranial hemorrhage, or drug use. | Up through the first 12 months of life |
| Percentage of Pregnant Participants Experiencing Gestational Hypertension | Gestational hypertension is defined as high blood pressure (Elevated: systolic between 120-129 mm Hg and diastolic less than 80 mm Hg; Stage 1 hypertension: systolic between 130-139 mm Hg or diastolic between 80-89 mm Hg; Stage 2 hypertension: systolic at least 140 mm Hg or diastolic at least 90 mm Hg) associated with pregnancy. | Up through the first 12 months of life |
| Percentage of Pregnant Participants Experiencing Gestational Diabetes | Gestational diabetes is generally characterized by the development of carbohydrate intolerance with first onset or first recognition during pregnancy; a record of an oral glucose tolerance test during pregnancy will also be accepted for data collection, where available. | Up through the first 12 months of life |
| Percentage of Infants Experiencing Preterm Birth | Preterm birth is defined as an infant born at gestational age <37 weeks. | Up through the first 12 months of life |
| Percentage of Infants Experiencing Small for Gestational Age (SGA) Birth | SGA at birth based on health care provider (HCP) report, typically defined as birthweight <=10th percentile for sex and gestational age. | Up through the first 12 months of life |
| Percentage of Infants Experiencing Minor Malformations | Minor malformations not previously reported. | Up through the first 12 months of life |
| Percentage of Infants With Age-appropriate Infant Growth and Development | Age-appropriate progress on developmental milestones based on the overall assessment by the infant's HCP (e.g., appropriate or delayed) up to 1 year of age. | Up through the first 12 months of life |
| Ottawa Hospital Research Institute /ID# 280174 |
| Recruiting |
| Ottawa |
| Ontario |
| K1Y 4E9 |
| Canada |
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| D009422 | Nervous System Diseases |