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

NCT03350399 | Unknown

• 1 other identifier: asamy
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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 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

Conditions

Intra Uterine Growth Retardation

Outcome Measures

Primary Outcomes (1)

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

  2 month

Study Arms (1)

level of placenta growth factor in IUGR

Diagnostic Test: placenta growth factor

Interventions

placenta growth factor DIAGNOSTIC_TEST

estimation level of derum placenta growth factor

level of placenta growth factor in IUGR

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

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.

You may qualify if:

• \- 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

You may not qualify if:

• 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

Sponsors & Collaborators

• amera mohamed: lead

Study Sites (1)

Ain Sahms University

Cairo, Egypt

Location

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: November 13, 2017
• First Posted: November 22, 2017
• Study Start: September 20, 2017
• Primary Completion: December 20, 2017
• Study Completion: March 20, 2018
• Last Updated: November 22, 2017

Record last verified: 2017-11

Locations

EG (1)