Advanced Multi-Modal Wearable Sensing for the Prediction of Pre-Term Labor
調査の概要
詳細な説明
The primary objective of the Prentice study is to assess and validate EMG performance of the new home-use sensor with extended battery life in detecting continuous EHG in a range of uterine contraction intensities, frequencies, and durations compared to gold-standard FDA-cleared tocodynamometer (GE Corometrics 250cx) in non-stress testing for antepartum surveillance.
An "at-home" study will validate the developed modifications to the wearable sensors system that provides a continuous electrohysterography (EHG) along with other additional physiological parameters (e.g. heart rate, heart rate variability, sleep quality, physical activity, and continuous blood pressure) for longitudinal monitoring in the home setting.
研究の種類
入学 (実際)
連絡先と場所
研究場所
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Illinois
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Chicago、Illinois、アメリカ、60611
- Northwestern University
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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
- Maternal age >18 years old
- Pregnant mothers >13 weeks (home study only)
- Pregnant mothers >26 weeks undergoing nonstress testing or delivering
- Singleton pregnancy (inpatient or clinic visit patients only)
- History of preterm labor or premature birth, active smoker, chronic condition (ex: HTN or DM), or an interval of less than 6 months between the prior pregnancy
- Singleton pregnancy (home study only)
- No fetal abnormality or chromosomal abnormality
- Subjects willing and able to comply with requirements of the protocol
Exclusion Criteria
- Women who refuse to signed the informed consent form
- Maternal age under 18 years old
- Multiple pregnancy
- Known major fetal malformation or chromosomal abnormality
- Medical or obstetric problem that would preclude the use of abdominal electrodes
- Inability to consent to this study due to medical illness, diminished intellectual capacity, or language barrier
- Women using pacemakers
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：コホート
- 時間の展望：見込みのある
コホートと介入
グループ/コホート |
介入・治療 |
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Subjects seen in hospital
Subjects will be recruited from Prentice Women's Hospital inpatient antepartum and labor and delivery services, and the outpatient Obstetrics and Gynecology practice, located within Galter tower with the assistance of staff.
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vital signs monitoring during maternal non-stress testing or in the home setting
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Home Study subjects
Subjects will be prescreened by an IRB approved staff and recruited from Prentice Women's Hospital's Department of Obstetrics and Gynecology.
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vital signs monitoring during maternal non-stress testing or in the home setting
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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 |
|---|---|---|
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Device comparison to standard monitoring
時間枠：2 years
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The primary outcome measure is concordance of FHR tracing assessments from Rogers sensor recordings with those obtained from the current standard of care electronic fetal monitoring systems.
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2 years
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協力者と研究者
スポンサー
捜査官
- 主任研究者：Shuai Xu, MD、Northwestern University
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
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
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。