The Relationship Between Second Trimester Placental Growth Factor Level and Fetal Growth Restriction
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|ClinicalTrials.gov Identifier: NCT03350399|
Recruitment Status : Unknown
Verified November 2017 by amera mohamed, Ain Shams University.
Recruitment status was: Active, not recruiting
First Posted : November 22, 2017
Last Update Posted : November 22, 2017
Type of the study:
A prospective observational study
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.
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).
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
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.
|Condition or disease||Intervention/treatment|
|Intra Uterine Growth Retardation||Diagnostic Test: placenta growth factor|
|Study Type :||Observational|
|Estimated Enrollment :||60 participants|
|Official Title:||The Relationship Between Second Trimester Placental Growth Factor Level and Fetal Growth Restriction|
|Actual Study Start Date :||September 20, 2017|
|Estimated Primary Completion Date :||December 20, 2017|
|Estimated Study Completion Date :||March 20, 2018|
|level of placenta growth factor in IUGR||
Diagnostic Test: placenta growth factor
estimation level of derum placenta growth factor
- Birth weight below 10th percentile will be calculated as the primary outcome. [ Time Frame: 2 month ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03350399
|Ain Sahms University|