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.
調査の概要
状態
研究の種類
入学 (推定)
連絡先と場所
研究連絡先
- 名前：Study Contact
- 電話番号：844-434-4210
- メール：Participate-In-This-Study1@its.jnj.com
参加基準
適格基準
就学可能な年齢
- 子
- 大人
- 高齢者
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
The study population are cases reported to the Company global safety database from post-marketing reports of exposure to nipocalimab during pregnancy.
説明
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)
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 観測モデル：COHORT
- 時間の展望：PROSPECTIVE
コホートと介入
グループ/コホート |
|---|
|
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. |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Prevalence of Fetal Growth Restriction
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Prevalence of Live Birth
時間枠：At Delivery
|
Delivery of a live newborn. |
At Delivery
|
|
Prevalence of Spontaneous Abortion
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：28 days to 365 days after birth
|
Death that occurs between 28 and 365 days of life. |
28 days to 365 days after birth
|
協力者と研究者
捜査官
- スタディディレクター：Janssen Research & Development, LLC Clinical Trial、Janssen Research & Development, LLC
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- 80202135MYG4003
- 80202135MYG4003 (その他の識別子：Janssen Research & Development, LLC)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
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
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。