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

Study Overview

• Status: Unknown
• Conditions: Intra Uterine Growth Retardation
• Intervention / Treatment: Diagnostic test: placenta growth factor

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 Type: Observational
• Enrollment (Anticipated): 60

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Ain Sahms University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• 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.

Description

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:

• 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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
level of placenta growth factor in IUGR	Diagnostic test: placenta growth factor; estimation level of derum placenta growth factor

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Birth weight below 10th percentile will be calculated as the primary outcome.	2 month

Collaborators and Investigators

• Sponsor: amera mohamed

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 20, 2017
• Primary Completion (ANTICIPATED): December 20, 2017
• Study Completion (ANTICIPATED): March 20, 2018

Study Registration Dates

• First Submitted: November 13, 2017
• First Submitted That Met QC Criteria: November 17, 2017
• First Posted (ACTUAL): November 22, 2017

Study Record Updates

• Last Update Posted (ACTUAL): November 22, 2017
• Last Update Submitted That Met QC Criteria: November 17, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Fetal Diseases; Pregnancy Complications; Growth Disorders; Fetal Growth Retardation; Molecular Mechanisms of Pharmacological Action; Mitosis Modulators; Mitogens
• Other Study ID Numbers: asamy

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No