Continuous Non-Invasive Measurement of Hemoglobin During Parturition
調査の概要
詳細な説明
Obstetric hemorrhage remains the leading cause of maternal death worldwide (2). The most common culprits are uterine atony, placental disorders, and delivery trauma. Current detection and management of hemorrhage is heavily based on clinical judgment and laboratory results. Interventions such as fluid resuscitation and blood transfusion are often initiated after a significant hemorrhage has already taken place. Early detection and treatment of this potentially life threatening obstetric complication is of upmost importance in the field of obstetrics. Traditional methods for assessing hemoglobin levels involve collecting the patient's blood and sending it to the laboratory for analysis via complete blood count (CBC). This involves a delay and often patients are continuing to hemorrhage while the CBC is being processed. Novel technology has recently been approved by the FDA, which can continuously assess hemoglobin levels via a non-invasive monitor. This device works as a pulse oximeter, which is placed on the index finger and uses infrared technology to estimate hemoglobin levels (1). Despite its validation and use in many patient populations such as trauma, neurosurgery and orthopedic surgery, data is lacking in an obstetric population. The investigator's hypothesis is that this device will enable clinicians detect hemorrhage early and initiate resuscitation such as fluid and/or blood transfusion before significant hemorrhage has taken place. This study will be a proof of concept prospective cohort study, in which the investigators will attempt to detect the association between intra-operative and postoperative continuous non-invasive hemoglobin monitoring and postpartum decrease in hemoglobin.
Women undergoing primary cesarean delivery after failed induction of labor or repeat cesarean delivery after failed TOLAC (trial of labor after cesarean delivery), will be eligible for participation in this study. Prior to cesarean, all patients will have a CBC drawn. Masimo non-invasive hemoglobin monitor will be placed on their finger during delivery and remain in place until discharge from the recovery room. All patients will have CBC drawn on post operative day 1, as is the standard of care at our institution. Based on the drop in hemoglobin from pre-op to post-op day 1, patients will be separated into quartiles. The quartile with the highest drop in hemoglobin will be the "cases" and compared to the remainder of the quartiles or "controls." In addition, values obtained from the non-invasive monitor will be compared to those obtained from CBC.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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Texas
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Galveston、Texas、アメリカ、77555
- University of Texas Medical Branch
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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
説明
Inclusion Criteria:
- Pregnant women undergoing primary cesarean delivery after failed induction of labor, or repeat cesarean delivery after failed TOLAC (trial of labor after cesarean)
- Pregnant women between the ages of 18-50
Exclusion Criteria:
- Patient who are not pregnant
- Patients unwilling or unable to provide consent
- Patients under the age of 18
- Patients who are incarcerated
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
- 主な目的:診断
- 割り当て:なし
- 介入モデル:単一グループの割り当て
- マスキング:なし(オープンラベル)
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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他の:All Participants
All patients who agree to participate in the study will have the Masimo Rainbow Pulse CO-Oximeter non-invasive hemoglobin monitor placed on their finger during cesarean delivery.
A CBC will be drawn immediately prior to delivery and this value will be compared to the values obtained from the monitor.
The patients will be separated into quartiles based on total drop in hemoglobin (pre-op to post-op day 1) and the values from the monitor compared between quartiles.
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Masimo Rainbow Pulse CO-oximeter will be used to measure hemoglobin values of pregnant women during primary cesarean delivery
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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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Pearson Correlation Coefficient for Hemoglobin Measurements
時間枠:1 day post partum
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Pearson Correlation Coefficient for hemoglobin measurements (Difference in Hemoglobin blood counts in g/dL between preop and post operative levels) obtained from blood draw to those obtained from the monitor
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1 day post partum
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Number of Participants Who Required Blood Transfusion
時間枠:0-5 days post partum
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The rates in percentage of patients that received transfusion of packed red blood cells.
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0-5 days post partum
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協力者と研究者
捜査官
- 主任研究者:Katherine H Jelliffe, MD、University of Texas
- スタディディレクター:Antonio F Saad, MD、University of Texas
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。
Masimo Rainbow Pulse CO-oximeterの臨床試験
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Cairo UniversityAbdelhamid, Bassant Mohamed, M.D.; Mohamed, Ahmed A., M.D.; Ashraf Mohamed Abd Elmawgod; Hossam...完了産科処置中の術中輸血実習における Masimo Radical Pulse Co oximeterエジプト