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临床试验/NCT03350399
NCT03350399Unknown不适用

The Relationship Between Second Trimester Placental Growth Factor Level and Fetal Growth Restriction

amera mohamed1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2017年9月20日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
60
试验地点
1
主要终点
Birth weight below 10th percentile will be calculated as the primary outcome.

研究概览

简要总结

Type of the study:

A prospective observational study

Study settings:

The study will be conducted at Ain Shams University Maternity Hospital, Obstetrics and Gynecology Department, Faculty of medicine over a period of six month from July 2017 to December 2017.

Study population:

The study population comprises 60 pregnant women at 13 to 28 week of gestation attending outpatient clinic and emergency Ain Shams University Maternity Hospital, Obstetrics and Gynecology Department, Faculty of medicine.

Sample size justification Sample size was calculated using PASS 11.0 sample size calculation program and based on the study carried out by Benton, et al. (2016) Group sample sizes of 30 in group one (IUGR) and 30 in group two (Controls) achieve 80% power to detect a difference between the group proportions of 0.2910. The proportion in group one (the treatment group) is assumed to be 0.2940 under the null hypothesis and 0.5850 under the alternative hypothesis. The proportion in group two (the control group) is 0.2940. The test statistic used is the two-sided Z test with pooled variance. The significance level of the test was targeted at 0.0500. The significance level actually achieved by this design is 0.0506. The primary outcome is birth weight below the 10 the percentile. The sample size was inflated by 15.0% to account for lost to follow up (attrition problem).

Inclusion criteria:

Singleton pregnancy between 13-28 weeks of gestation. Pregnant women aged 18 - 35 years Pregnant women with fetal abdominal circumference (AC) < 10th percentile for gestational age (GA) on ultrasound

Exclusion criteria:

To exclude any factors that cause IUGR:

Chronic or gestational hypertension and/or preeclampsia Premature rupture of membranes A fetus with known chromosomal and/or congenital abnormalities confirmed after delivery.

Multiple gestation

详细描述

Full history: including age, gravidity, parity and gestational age Clinical examination: be physically examined. Abdominal examination and measurement of symphsis-fundal height Diagnosis of IUGR will be confirmed by ultrasound and confirmed by Doppler ultrasound of Umbilical artery and cerebral artery blood flow in 3rd trimester

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 35 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Singleton pregnancy between 13-28 weeks of gestation. Pregnant women aged 18 - 35 years Pregnant women with fetal abdominal circumference (AC) < 10th percentile for gestational age (GA) on ultrasound

排除标准

  • Chronic or gestational hypertension and/or preeclampsia Premature rupture of membranes A fetus with known chromosomal and/or congenital abnormalities confirmed after delivery.
  • Multiple gestation

结局指标

主要结局

Birth weight below 10th percentile will be calculated as the primary outcome.

时间窗: 2 month

次要结局

未报告次要终点

研究者

发起方
amera mohamed
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

amera mohamed

professor

Ain Shams University

研究点 (1)

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