Prospective Registry of Exposure to Gepotidacin (PREG)
Prospective Registry of Exposure to Gepotidacin (PREG): a Prospective Registry of Women and Their Offspring Exposed to Gepotidacin During Pregnancy
The purpose of this study is to monitor pregnancies exposed to gepotidacin and to evaluate possible teratogenic effects or birthweight-lowering effects of this medication relative to the primary outcomes of major congenital malformations (MCMs) and small for gestational age (SGA), as well as to evaluate secondary maternal, fetal, and infant outcomes.
調査の概要
研究の種類
入学 (推定)
連絡先と場所
研究連絡先
- 名前:US GSK Clinical Trials Call Center
- 電話番号:877-379-3718
- メール:GSKClinicalSupportHD@gsk.com
研究連絡先のバックアップ
- 名前:EU GSK Clinical Trials Call Center
- 電話番号:+44 (0) 20 89904466
- メール:GSKClinicalSupportHD@gsk.com
参加基準
適格基準
就学可能な年齢
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
Pregnant participants with uncomplicated urinary tract infection who are exposed to gepotidacin or standard-of-care antibiotics during the relevant exposure window.
説明
Inclusion Criteria:
For Both cohorts:
- Participants with aged 15 to 50 years
- United States resident
- Currently pregnant
- Participants personally signed and dated informed consent document or, upon waiver of written consent by the relevant Institutional review board (IRB), verbal consent indicating that the participant (or a legally acceptable representative) has been informed of all pertinent aspects of the study
- Authorization and contact information for the reporter (e.g., participant, maternal/infant Health care provider (HCP), prescriber) to allow for follow-up
Exposed cohort:
• Exposed to gepotidacin at any time during pregnancy or the relevant exposure window
Comparator cohort:
- Diagnosis of and treatment for uUTI at any time during pregnancy or the relevant comparator product exposure window
- Exposed to one or more American College of Obstetricians and Gynecologists (ACOG)-recommended treatments for acute cystitis at any time during pregnancy or the relevant comparator product exposure window
Exclusion Criteria:
For Both cohorts:
• Diagnosis of known MCMs for the index pregnancy prior to enrollment
Exposed cohort:
• None
Comparator cohort:
• Exposure to gepotidacin at the time of enrollment
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 |
介入・治療 |
|---|---|
|
Exposed cohort
Pregnant participants with uncomplicated urinary tract infection (uUTI) who are exposed to gepotidacin during the relevant exposure window |
Not Applicable since Observational Study
他の名前:
|
|
Comparator cohort
Pregnant participants with uncomplicated urinary tract infection (uUTI) who are exposed to standard-of-care antibiotics during the relevant exposure window |
Not Applicable since Observational Study
他の名前:
|
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 |
|---|---|---|
|
Number of infants with major congenital malformations (MCMs)
時間枠:At pregnancy outcome, with follow-up through 12 months after delivery
|
An abnormality of body structure or function that is present at birth, is of prenatal origin (i.e., birth defect), has significant medical, social, or cosmetic consequences for the affected individual, and typically requires medical intervention. |
At pregnancy outcome, with follow-up through 12 months after delivery
|
|
Number of infants with small-for-gestational-age births (SGA)
時間枠:At live birth
|
A newborn infant whose birth weight is less than (<) 10th percentile for sex and gestational age using standard growth charts for full- and preterm live-born infants. |
At live birth
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Number of infants with minor congenital malformations
時間枠:At live Birth, with follow-up up through 12 months of age
|
An anomaly or abnormality of body structure that is present at birth, is of prenatal origin (i.e., birth defect), poses no significant health problem in the neonatal period, and tends to have limited social or cosmetic consequences for the affected individual. |
At live Birth, with follow-up up through 12 months of age
|
|
Number of participants (pregnant women) with pregnancy termination
時間枠:From date of conception (DOC) to <20 gestational weeks
|
A voluntary fetal loss or interruption of pregnancy that occurs for any reason, including but not limited to for the preservation of maternal health or because of fetal abnormalities. |
From date of conception (DOC) to <20 gestational weeks
|
|
Number of participants (pregnant women) with spontaneous abortions (SAB)
時間枠:From date of conception (DOC) to <20 gestational weeks
|
An involuntary fetal loss or the expulsion of the products of conception occurring at less than (<) 20 gestational weeks. |
From date of conception (DOC) to <20 gestational weeks
|
|
Number of participants (pregnant women) with stillbirths
時間枠:From 20 weeks' gestation to pregnancy outcome
|
Stillbirth is defined by the American College of Obstetricians and Gynecologists (ACOG), an involuntary fetal loss occurring at greater than or equal to (>=) 20 weeks of gestation, or, if gestational age is unknown, a fetus weighing >=350 grams. |
From 20 weeks' gestation to pregnancy outcome
|
|
Number of participants (pregnant women) with preeclampsia
時間枠:From 20 weeks' gestation to pregnancy outcome
|
Preeclampsia is disorder of pregnancy associated with new-onset hypertension, which occurs most often after 20 weeks of gestation and frequently near term, and proteinuria, or, in the absence of proteinuria, it is defined as new-onset hypertension with the new onset of any of the following: Thrombocytopenia: platelet count <100,000/milliliter (mL). Renal insufficiency: serum creatinine concentrations >1.1 milligram per deciliter (mg/dL) or a doubling of the serum creatinine concentration in the absence of other renal disease. Impaired liver function: elevated blood concentrations of liver transaminases to twice the normal concentration. Pulmonary edema. New-onset headache unresponsive to medication and not accounted for by alternative diagnoses or visual symptoms |
From 20 weeks' gestation to pregnancy outcome
|
|
Number of participants (pregnant women) with eclampsia
時間枠:From 20 weeks' gestation to pregnancy outcome
|
New-onset tonic-clonic, focal, or multifocal seizures in the absence of other causative conditions such as epilepsy, cerebral arterial ischemia and infarction, intracranial hemorrhage, or drug use. |
From 20 weeks' gestation to pregnancy outcome
|
|
Number of participants (pregnant women) with gestational hypertension
時間枠:From 20 weeks' gestation to pregnancy outcome
|
Blood pressure greater than 140 millimeter of mercury (mmHg) systolic or 90 mmHg diastolic on 2 separate occasions at least 4 hours apart after 20 weeks of pregnancy when previous blood pressure was normal. |
From 20 weeks' gestation to pregnancy outcome
|
|
Number of participants (pregnant women) with gestational diabetes
時間枠:At pregnancy outcome
|
Any degree of glucose intolerance with onset or first recognition during pregnancy. |
At pregnancy outcome
|
|
Number of participants (pregnant women) with preterm births
時間枠:At live birth, if occurring before 37 gestational weeks
|
Preterm birth is defined as a live birth occurring at <37 gestational weeks. |
At live birth, if occurring before 37 gestational weeks
|
|
Number of infants with postnatal growth deficiency
時間枠:At 4 and 12 months of infant age
|
Weight, length, or head circumference in <10th percentile for sex and chronological age using standard growth charts |
At 4 and 12 months of infant age
|
|
Number of infants with developmental delay
時間枠:At 4 and 12 months of infant age
|
Failure to achieve the developmental milestones for chronological age, as defined by the Centers for Disease Control and Prevention. |
At 4 and 12 months of infant age
|
協力者と研究者
スポンサー
捜査官
- スタディディレクター:GSK Clinical Trials、GlaxoSmithKline
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
追加の関連 MeSH 用語
その他の研究ID番号
- 300392
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?
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。