Comparison Between Amniotic Fluid Lamellar Body Count and Fetal Pulmonary Artery Doppler Indices in Predicting Fetal Lung Maturity
調査の概要
詳細な説明
Neonatal respiratory distress syndrome (RDS) remains a major cause of neonatal morbidity and mortality. A recent epidemiologic study in the United States estimates that there are 80,000 cases of neonatal RDS each year, resulting in 8500 deaths and hospital costs in excess of $4.4 billion.
A number of biochemical tests have been developed to predict the risk of RDS and assist obstetric care providers in delivery timing. Amniotic fluid lamellar body count (LBC) is an important biophysical test, based on measuring the concentration of pulmonary surfactant in amniotic fluid. It can be effectively used to assess fetal lung maturity. A noninvasive test for fetal lung maturity (FLM) would be useful to minimize the need for invasive testing and would be more acceptable to women. Fetal pulmonary artery Doppler waveform acceleration/ejection time may provide a noninvasive means of determining fetal lung maturity with relatively acceptable levels of sensitivity, specificity, and predictive values.
The investigators will study 200 women with singleton pregnancies presented with prelabor preterm rupture of membranes or undergoing cesarean section (CS). Amniotic fluid lamellar body count (LBC) and fetal pulmonary artery Doppler will be done to all women. LBC and fetal pulmonary artery Doppler will be correlated with fetal outcome.
Quantitative data will be statistically represented in terms of mean ± standard deviation (± SD) while categorical data will be represented as frequency and percentage. Comparison of quantitative data will be done using Mann Whitney U test for independent samples while categorical data will compared using Chi squared test or Fisher exact test when appropriate. A probability value (p value) less than 0.05 will be considered significant.
研究の種類
入学 (予想される)
段階
- フェーズ 3
連絡先と場所
研究連絡先
- 名前:AbdelGany MA Hassan, MRCOG, MD
- 電話番号:+201017801604
- メール:abdelgany2@gmail.com
研究場所
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Cairo、エジプト
- 募集
- Cairo University Hospitals
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コンタクト:
- AbdelGany Hassan, MRCOG, MD
- 電話番号:002 01017801604
- メール:abdelgany2@gmail.com
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副調査官:
- AbdelGany MA Hassan, MRCOG, MD
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主任研究者:
- Sherif Negm, MD
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副調査官:
- Doaa Salah, MD
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Cairo、エジプト
- 募集
- Al Galaa maternity fospital
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コンタクト:
- Mohamed Wafeek
- 電話番号:002 01223524286
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主任研究者:
- Mohamed Wafeek
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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:
- Singleton pregnancies without any major congenital anomalies.
- Gestation between 32-36 weeks
- Women presenting preterm pre-labour ruptured membranes or undergoing a cesarean section.
Exclusion Criteria:
- Patients with major fetal anomalies.
- Bloody or meconium stained amniotic fluid
- preexisting maternal medical conditions (eg, diabetes, renal disease, hypertensive disorders, vaginal bleeding
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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実験的:preterm labour
200 women with preterm prelabour ruptured membranes or undergoing preterm CS
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The LBC (the unit of measurement is number of lamellar bodies counted per microliter of amniotic fluid) will be determined using the platelet channels on the Hematology Flow Cytometer.
他の名前:
A fetal pulmonary artery Doppler will be performed using color Doppler ultrasound.
Doppler flow velocity measurements, including systolic/diastolic ratio, pulsatility index, resistance index, and acceleration-time/ejection-time ratio using spectral Doppler ultrasound.
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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 |
---|---|---|
Respiratory distress syndrome (RDS)
時間枠:1 day after delivery
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RDS will be diagnosed clinically by the presence of tachypnea, working respiratory muscles, expiratory grunt, and chest x-ray.
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1 day after delivery
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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 |
---|---|---|
Need for incubation
時間枠:1 day after delivery
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It will be recorded if the pediatrician decides to incubate the neonate.
The reason for incubation e.g.
ventilation, hypoxia, ischemia will be recorded.
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1 day after delivery
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協力者と研究者
スポンサー
出版物と役立つリンク
一般刊行物
- AVERY ME, MEAD J. Surface properties in relation to atelectasis and hyaline membrane disease. AMA J Dis Child. 1959 May;97(5, Part 1):517-23. doi: 10.1001/archpedi.1959.02070010519001. No abstract available.
- Dubin SB. Characterization of amniotic fluid lamellar bodies by resistive-pulse counting: relationship to measures of fetal lung maturity. Clin Chem. 1989 Apr;35(4):612-6.
- Neerhof MG, Dohnal JC, Ashwood ER, Lee IS, Anceschi MM. Lamellar body counts: a consensus on protocol. Obstet Gynecol. 2001 Feb;97(2):318-20. doi: 10.1016/s0029-7844(00)01134-0.
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)
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
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