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Correlation Between Placental Thickness in the Second and Third Trimester and Fetal Weight

2017年4月21日 更新者:amr elsayed elsayed、Ain Shams Maternity Hospital
The aim of this prospective longitudinal study was to investigate the relationship between placental thickness during the second and third trimesters and placental and birth weights.

研究概览

地位

完全的

干预/治疗

详细说明

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)

研究类型

观察性的

注册 (实际的)

395

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Elabbasia
      • Cairo、Elabbasia、埃及
        • Ain Shams Faculty of Medicine

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

20年 至 30年 (成人)

接受健康志愿者

有资格学习的性别

女性

取样方法

非概率样本

研究人群

uncomplicated pregnant women who will attend the outpatient clinic at Ain Shams University Maternity Hospital

描述

Inclusion Criteria:

  1. patient Aged between 18 and 45 years.
  2. singleton viable pregnancy.
  3. non scared uterus.

Exclusion Criteria:

  1. systemic illness (DM,Hypertension, renal disease, liver disease, sickle cell disease)
  2. known congenital fetal anomalies.
  3. multiple pregnancy.
  4. intra uterine fetal death.
  5. anatomical defect of pregnant uterus
  6. abnormally located placenta or placental anomalies
  7. morbid obesity
  8. missing records
  9. unwilling to incorporate in the study.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 观测模型:队列
  • 时间观点:预期

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Fetal Weight (Fetal Weight at Birth)
大体时间:9 months
Fetal weight (fetal weight at birth) (in grams)
9 months
Placental Thickness in Second Trimester
大体时间:15-20 weeks of gestation
placental thickness measured in millimeter
15-20 weeks of gestation
Placental Thickness at 3rd Trimester
大体时间:30-34 weeks of pregnancy
30-34 weeks of pregnancy

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 研究主任:AHMED MEKLED, Professor、ain shams University
  • 研究主任:HAYTHAM SABAA, Lecturer、ain shams University

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2015年3月1日

初级完成 (实际的)

2016年12月1日

研究完成 (实际的)

2017年1月1日

研究注册日期

首次提交

2015年5月10日

首先提交符合 QC 标准的

2015年6月13日

首次发布 (估计)

2015年6月17日

研究记录更新

最后更新发布 (实际的)

2017年8月2日

上次提交的符合 QC 标准的更新

2017年4月21日

最后验证

2017年4月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

药物和器械信息、研究文件

研究美国 FDA 监管的药品

研究美国 FDA 监管的设备产品

在美国制造并从美国出口的产品

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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