Preterm Delivery Risk Prediction by Measurement of Prenatal Serum Screening Markers
Early Prediction Of Preterm Delivery By Measurement Of Maternal Serum Markers
調査の概要
状態
条件
詳細な説明
The study will investigate whether the levels of individual maternal serum screening biomarkers, their combinations or temporal changes in the level can be associated with an increased risk of preterm delivery. Blood samples at three time points in pregnancy will be collected from the study participants. The first two blood draws will be timed to coincide with the first and second trimester maternal serum testing. The third blood draw will coincide with the screening for gestational diabetes. Pregnancy outcome information will be collected from the physicians and linked to the subject samples.
Subject samples from a case-control patient group will be analyzed by the serum screening biochemical assay. Statistical analyses will be performed to achieve the study objectives.
NOTE: This study is recruiting in Florida, USA. The laboratory data coordination is being performed in Massachusetts, USA and New Mexico, USA. New study locations will be identified on an ongoing basis.
研究の種類
入学 (予想される)
連絡先と場所
研究場所
-
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Massachusetts
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Westborough、Massachusetts、アメリカ、01581
- Integrated Genetics
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New Mexico
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Santa Fe、New Mexico、アメリカ、87505
- Integrated Genetics
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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
説明
Inclusion Criteria:
- The participant understands the nature of the study and its requirements. To this end, we will require that the participants have command of the English language.
- The participant consents to and signs the approved consent form.
- The participant is 18 years of age or older.
- The participant has a singleton pregnancy.
- The participant is planning on continuing the pregnancy.
- The participant has intent to clinically test for Down syndrome risk.
- The participant consents to the study at the first trimester of her pregnancy.
- The participant understands the nature of the study and its requirements. To this end, we will require that the participants have command of either the English or Spanish language.
Exclusion Criteria:
- N/A
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
協力者と研究者
捜査官
- スタディディレクター:Medical Monitor、Esoterix Genetic Laboratories, LLC
出版物と役立つリンク
一般刊行物
- Chitayat D, Farrell SA, Huang T, Meier C, Wyatt PR, Summers AM. Double-positive maternal serum screening results for down syndrome and open neural tube defects: An indicator for fetal structural or chromosomal abnormalities and adverse obstetric outcomes. Am J Obstet Gynecol. 2002 Sep;187(3):758-63. doi: 10.1067/mob.2002.125240.
- Lepage N, Chitayat D, Kingdom J, Huang T. Association between second-trimester isolated high maternal serum maternal serum human chorionic gonadotropin levels and obstetric complications in singleton and twin pregnancies. Am J Obstet Gynecol. 2003 May;188(5):1354-9. doi: 10.1067/mob.2003.278.
研究記録日
主要日程の研究
研究開始
一次修了 (予想される)
研究の完了 (予想される)
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 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
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
キーワード
その他の研究ID番号
- GGPS0001
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。