Correlation Between Placental Thickness in the Second and Third Trimester and Fetal Weight
調査の概要
詳細な説明
The investigator will make certain that the appropriate informed consent process is in place to ensure that potential research subjects, or their authorized representatives, are fully informed about the nature and objectives of the study, the potential risk and benefits of study participation, and their right as research subjects.
All laboratory specimens, evaluation forms, reports, video recordings, and other records that leave the site will not include unique personal data to maintain subject confidentiality.
All patients provided an informed written consent after they were fully instructed about the investigation.The study was approved by ethical committee of Ain Shams University.
All recruited women were observed at the 1st trimester screening at antenatal clinic and assessed for baseline demographic and obstetric data including age, parity, body mass index (BMI) and past medical events. Smoking, alcohol and drug use were also determined.
At second and third trimester (15-20 and 30-34 weeks of gestation respectively), the maternal weight, weight gain, BMI, BMI gain and data of ultrasound examination were recorded. At the time of delivery after assessment of maternal weight as mentioned above, the birth weight (in grams), fetal sex, and mode of delivery were taken.
All pregnant women underwent ultrasound evaluation of placental thickness at the time of second trimester (15-20 weeks of gestation) as well as third trimester (30-34 weeks of gestation).
All sonographic examinations were performed trans-abdominal using a Medison X4 ultrasound machine Trans abdominal4.0 megahertz (MHz) probe at The Special Care Center for Fetus Unit at Ain Shams University Maternity Hospital.
The placental thickness was measured by placing the ultrasound transducer perpendicularly to the plane of the placenta, in the area of the cord insertion, near the mid-placental portion as described by Hoddick et al
Each evaluation was performed by one of two experienced sonographers of our hospital with minimum inter- and intra-observer variability.
After delivery, the placenta was weighed in grams as previously described by Azpurua et al.
Fetal weight (primary objective) and neonatal status and morbidity including baby Apgar scores, fetal distress or fetal death and admission to the neonatal intensive care unit were also determined. All the examinations and data recording were performed by two senior resident physicians.(secondary objective)
研究の種類
入学 (実際)
連絡先と場所
研究場所
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Elabbasia
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Cairo、Elabbasia、エジプト
- Ain Shams Faculty of Medicine
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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:
- patient Aged between 18 and 45 years.
- singleton viable pregnancy.
- non scared uterus.
Exclusion Criteria:
- systemic illness (DM,Hypertension, renal disease, liver disease, sickle cell disease)
- known congenital fetal anomalies.
- multiple pregnancy.
- intra uterine fetal death.
- anatomical defect of pregnant uterus
- abnormally located placenta or placental anomalies
- morbid obesity
- missing records
- unwilling to incorporate in the study.
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
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 |
---|---|---|
Fetal Weight (Fetal Weight at Birth)
時間枠:9 months
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Fetal weight (fetal weight at birth) (in grams)
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9 months
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Placental Thickness in Second Trimester
時間枠:15-20 weeks of gestation
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placental thickness measured in millimeter
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15-20 weeks of gestation
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Placental Thickness at 3rd Trimester
時間枠:30-34 weeks of pregnancy
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30-34 weeks of pregnancy
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協力者と研究者
捜査官
- スタディディレクター:AHMED MEKLED, Professor、Ain Shams University
- スタディディレクター:HAYTHAM SABAA, Lecturer、Ain Shams University
出版物と役立つリンク
一般刊行物
- Azpurua H, Funai EF, Coraluzzi LM, Doherty LF, Sasson IE, Kliman M, Kliman HJ. Determination of placental weight using two-dimensional sonography and volumetric mathematic modeling. Am J Perinatol. 2010 Feb;27(2):151-5. doi: 10.1055/s-0029-1234034. Epub 2009 Aug 3.
- Hoddick WK, Mahony BS, Callen PW, Filly RA. Placental thickness. J Ultrasound Med. 1985 Sep;4(9):479-82. doi: 10.7863/jum.1985.4.9.479.
研究記録日
主要日程の研究
研究開始
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 (見積もり)
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。
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