A Study to Assess Pregnancy, Neonatal and Infant Outcomes in Participants Exposed to Nipocalimab (PETUNIA)
Nipocalimab Pregnancy Enhanced Tracking With Neonatal and Infant Assessment
The purpose of this study is to find out how often:
- Pregnancy problems, complications in mothers, and health issues in newborn babies occurred in participants who took nipocalimab just before or during pregnancy.
- Serious infections occur in newborns and infants born to participants who took nipocalimab just before or during pregnancy.
- Babies are born with major birth defects (not related to chromosomes) in pregnancies where nipocalimab was taken just before or during pregnancy.
Przegląd badań
Status
Warunki
Typ studiów
Zapisy (Szacowany)
Kontakty i lokalizacje
Kontakt w sprawie studiów
- Nazwa: Study Contact
- Numer telefonu: 844-434-4210
- E-mail: Participate-In-This-Study1@its.jnj.com
Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dziecko
- Dorosły
- Starszy dorosły
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Metoda próbkowania
Badana populacja
The study population are cases reported to the Company global safety database from post-marketing reports of exposure to nipocalimab during pregnancy.
Opis
Inclusion Criteria:
- Documented exposure to least one dose of nipocalimab any time immediately before ( 1 week [7 days ] before estimated date of conception) or during pregnancy in the post-marketing setting
Exclusion Criteria:
- Reports in which the pregnant person discontinued nipocalimab 1 week (7 days) before the estimated date of conception
- Indirect case reports (reported by someone other than the patient or the health care provider [HCP]) for which the reporter refuses to provide follow-up information, and the participants or HCP cannot be identified based on the information provided
- Case lacking reporter contact details
- Cases where only the father/male partner is exposed to nipocalimab during partner's pregnancy
- Cases occurring in an interventional setting (that is, clinical trials)
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Modele obserwacyjne: COHORT
- Perspektywy czasowe: PROSPECTIVE
Kohorty i interwencje
Grupa / Kohorta |
|---|
|
Participants Exposed to Nipocalimab Immediately Before or During Pregnancy
Participants with documented exposure to at least one dose of nipocalimab any time immediately before (within 1 week [7 days] before estimated date of conception) or during pregnancy in the post-marketing setting. No drug will be administered as a part of this study. Participants received nipocalimab as per their routine clinical practice settings. |
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Prevalence of Fetal Growth Restriction
Ramy czasowe: During pregnancy (Up to Week 42)
|
A fetus with an estimated fetal weight less than the 10th percentile for gestational age based upon a population reference or standard. |
During pregnancy (Up to Week 42)
|
|
Prevalence of Small for Gestational Age
Ramy czasowe: At birth
|
A newborn with a birthweight less than the 10th percentile for gestational age based upon a population reference or standard. |
At birth
|
|
Prevalence of Hypertensive Disorders of Pregnancy
Ramy czasowe: From 20 weeks gestation through 6 weeks postpartum
|
Hypertensive disorder of pregnancy (that is, preeclampsia, gestational hypertension, hemolysis, elevated liver enzymes, and low platelet count (HELLP) syndrome, or eclampsia). |
From 20 weeks gestation through 6 weeks postpartum
|
|
Prevalence of Placental Abruption
Ramy czasowe: During pregnancy (Up to Week 42)
|
A condition in which the placenta has begun to separate from the uterus before the fetus is born. |
During pregnancy (Up to Week 42)
|
|
Prevalence of Serious Infections in Neonates
Ramy czasowe: Birth to 27 days
|
Infections resulting in a hospitalization that occur within the first 27 days of life (0-27 days). |
Birth to 27 days
|
|
Prevalence of Serious Infections in Infants
Ramy czasowe: 28 days to 365 days after birth
|
Infections resulting in a hospitalization that occur between 28 and 365 days of life. |
28 days to 365 days after birth
|
|
Prevalence of Non-chromosomal Major Congenital Malformations
Ramy czasowe: During pregnancy (up to Week 42) and up to 1 year after birth
|
Congenital abnormality that requires medical or surgical treatment, has a serious adverse effect on health and development, or has significant cosmetic impact, excluding those that are chromosomal or Mendelian-inherited anomalies. |
During pregnancy (up to Week 42) and up to 1 year after birth
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Prevalence of Live Birth
Ramy czasowe: At Delivery
|
Delivery of a live newborn. |
At Delivery
|
|
Prevalence of Spontaneous Abortion
Ramy czasowe: Prior to 20 weeks gestation
|
Clinically detected pregnancy loss before 20 completed weeks of gestation that occurs without medical or surgical intervention to terminate the pregnancy. |
Prior to 20 weeks gestation
|
|
Prevalence of Stillbirth
Ramy czasowe: At or after 20 completed weeks of gestation
|
Fetus born dead at >= 20 weeks gestation or weighing >= 350 grams. Fetal death occurring > 20 weeks but less than 28 weeks gestation is considered an early fetal loss. Fetal death occurring > 28 weeks is considered a late fetal loss. If gestational age is unknown, stillbirth refers to a fetus weighing >= 350 grams. |
At or after 20 completed weeks of gestation
|
|
Prevalence of Preterm Birth
Ramy czasowe: Prior to 37 completed weeks of gestation
|
Delivery of a viable infant before 37 completed weeks of gestation. |
Prior to 37 completed weeks of gestation
|
|
Prevalence of Intrapartum Hemorrhage
Ramy czasowe: During pregnancy (Up to 42 weeks)
|
Maternal complication characterized by significant blood loss occurring during pregnancy. |
During pregnancy (Up to 42 weeks)
|
|
Prevalence of Postpartum Hemorrhage
Ramy czasowe: At Birth and after 12 weeks delivery
|
Maternal complication characterized by significant blood loss occurring after pregnancy. |
At Birth and after 12 weeks delivery
|
|
Prevalence of Neonatal Death
Ramy czasowe: Birth to 27 days
|
Death that occurs within the first 27 days of life (0-27 days). |
Birth to 27 days
|
|
Prevalence of Infant Death
Ramy czasowe: 28 days to 365 days after birth
|
Death that occurs between 28 and 365 days of life. |
28 days to 365 days after birth
|
Współpracownicy i badacze
Śledczy
- Dyrektor Studium: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Szacowany)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Inne numery identyfikacyjne badania
- 80202135MYG4003
- 80202135MYG4003 (Inny identyfikator: Janssen Research & Development, LLC)
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Opis planu IPD
The data sharing policy of Johnson & Johnson Innovative Medicine is available at www.jnj.com/innovativemedicine/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .