Ignite Creation Date:
2024-05-06 @ 10:47 AM
Last Modification Date:
2024-10-26 @ 12:35 PM
Study NCT ID:
NCT03350399
Status:
UNKNOWN
Last Update Posted:
2017-11-22
First Post:
2017-11-13
Brief Title:
The Relationship Between Second Trimester Placental Growth Factor Level and Fetal Growth Restriction
Sponsor:
amera mohamed
Organization:
Ain Shams University
Study Overview
Official Title:
The Relationship Between Second Trimester Placental Growth Factor Level and Fetal Growth Restriction
Status:
UNKNOWN
Status Verified Date:
2017-11
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 110 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 02910 The proportion in group one the treatment group is assumed to be 02940 under the null hypothesis and 05850 under the alternative hypothesis The proportion in group two the control group is 02940 The test statistic used is the two-sided Z test with pooled variance The significance level of the test was targeted at 00500 The significance level actually achieved by this design is 00506 The primary outcome is birth weight below the 10 the percentile The sample size was inflated by 150 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 andor preeclampsia Premature rupture of membranes A fetus with known chromosomal andor congenital abnormalities confirmed after delivery
Multiple gestation
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 110 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 02910 The proportion in group one the treatment group is assumed to be 02940 under the null hypothesis and 05850 under the alternative hypothesis The proportion in group two the control group is 02940 The test statistic used is the two-sided Z test with pooled variance The significance level of the test was targeted at 00500 The significance level actually achieved by this design is 00506 The primary outcome is birth weight below the 10 the percentile The sample size was inflated by 150 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 andor preeclampsia Premature rupture of membranes A fetus with known chromosomal andor congenital abnormalities confirmed after delivery
Multiple gestation
Detailed Description:
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None