Protein and Ultrasound Indicators of Preterm Birth
2016年4月22日 更新者：University of Colorado, Denver
Women are being asked to participate in a research study that is looking for new methods to understand and predict premature birth (birth before 37 weeks of pregnancy-full term pregnancy is 40 weeks).
In this study the investigators will be looking at proteins in vaginal fluid, tissue from the placenta after the baby is born (fetal membranes), and a new form of ultrasound of the mouth of the womb (cervix) that measures its length, volume, and stiffness, in order to try to know who will have a preterm birth and who will reach full term.
The investigators will collect the vaginal fluid samples and perform ultrasounds both in the clinic throughout pregnancy in normal women, and from women admitted to the hospital because they are in early labor.
The investigators will collect the placental tissue after the baby is born (this is normally discarded).
This study will help us to understand the process of preterm birth and the investigators hope that this will eventually allow us to develop better methods to treat preterm labor and prevent the birth of premature babies.
調査の概要
状態
完了
条件
研究の種類
観察的
入学 (実際)
3
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
-
-
Colorado
-
Denver、Colorado、アメリカ、80045
- University of Colorado Hospital
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
14年～45年 (子、大人)
健康ボランティアの受け入れ
はい
受講資格のある性別
女性
サンプリング方法
非確率サンプル
調査対象母集団
Pregnant women with a single intrauterine pregnancy with good gestational age dating, and live fetus with no indications for preterm delivery will be enrolled.
Three groups of subjects will be recruited: a) 50 women with uncomplicated pregnancies and no history of preterm birth, b) 50 multiparous women with history of spontaneous preterm labor or preterm premature rupture of membranes (PPROM) c) 20 women evaluated on the labor and delivery unit because they are deemed to be at high risk for preterm birth.
Pregnant women of all races and ethnicities will be recruited into the study.
説明
Inclusion Criteria:
- Single live intrauterine pregnancy
- Good gestational age dating
Exclusion Criteria:
- History of prior cervical procedure such as LEEP, CKC, or cryotherapy
- Maternal or fetal indication for preterm delivery
- Cerclage in place
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
|---|
|
1) Pregnant women with a single intrauterine pregnancy
50 women with uncomplicated pregnancies and no history of preterm birth.
|
|
2) Pregnant women with a single intrauterine pregnancy
50 multiparous women with history of spontaneous preterm labor or preterm premature rupture of membranes (PPROM).
|
|
3) Pregnant women with a single intrauterine pregnancy
20 women evaluated on the labor and delivery unit because they are deemed to be at high risk for preterm birth.
|
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 |
|---|---|---|
|
Changes in Serial Elastography Measurements
時間枠：Groups a and b, ultrasound imaging and CVF collection will occur no more than four times with one week spacing between assessments. Group "d" will be assessed more frequently (up to 1× per day).
|
Serial elastography measurements will enable us to quantify changes in tissue modulus and structure longitudinally through normal, term pregnancy.
|
Groups a and b, ultrasound imaging and CVF collection will occur no more than four times with one week spacing between assessments. Group "d" will be assessed more frequently (up to 1× per day).
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Changes in Biomechanical and biochemical analyses of the chorioamnion
時間枠：Groups a and b, ultrasound imaging and CVF collection will occur no more than four times with one week spacing between assessments. Group "d" will be assessed more frequently (up to 1× per day).
|
To quantify the strength and related mechanical properties, characterize the composition of the extracellular matrix, and characterize the secreted protein profile.
|
Groups a and b, ultrasound imaging and CVF collection will occur no more than four times with one week spacing between assessments. Group "d" will be assessed more frequently (up to 1× per day).
|
|
Correlation of Protein and biochemical analysis of the cervicovaginal fluid (CVF)
時間枠：Groups a and b, ultrasound imaging and CVF collection will occur no more than four times with one week spacing between assessments. Group "d" will be assessed more frequently (up to 1× per day).
|
Protein and biochemical analysis of the CVF, and correlation with cervical tissue stiffness and morphology, will enable detection of specific bio-markers that are present during normal and premature cervical ripening.
|
Groups a and b, ultrasound imaging and CVF collection will occur no more than four times with one week spacing between assessments. Group "d" will be assessed more frequently (up to 1× per day).
|
|
Stratification of Ultrasound parameters, chorioamnion biomechanical and biochemical properties, and CVF proteins .
時間枠：Groups a and b, ultrasound imaging and CVF collection will occur no more than four times with one week spacing between assessments. Group "d" will be assessed more frequently (up to 1× per day).
|
Identify specific values and biomarkers able to identify patients at risk of preterm labor and preterm birth.
|
Groups a and b, ultrasound imaging and CVF collection will occur no more than four times with one week spacing between assessments. Group "d" will be assessed more frequently (up to 1× per day).
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
捜査官
- 主任研究者：Virginia Ferguson, PhD、University of Colorado, Boulder
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始
2011年9月1日
一次修了 (実際)
2013年12月1日
研究の完了 (実際)
2013年12月1日
試験登録日
最初に提出
2011年8月8日
QC基準を満たした最初の提出物
2011年8月8日
最初の投稿 (見積もり)
2011年8月9日
学習記録の更新
投稿された最後の更新 (見積もり)
2016年4月26日
QC基準を満たした最後の更新が送信されました
2016年4月22日
最終確認日
2016年4月1日
詳しくは
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。