Intra Uterine Growth Retardation Clinical Trial
Official title:
The Relationship Between Second Trimester Placental Growth Factor Level and Fetal Growth Restriction
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
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 ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Terminated |
NCT00549575 -
L-Arginine Treatment for Severe Vascular Fetal Intrauterine Growth Restriction: a Randomized Double Bind Controlled Trial (L Arginine in IUGR)
|
Phase 3 |