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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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
Sponsor:
Information provided by (Responsible Party):
amera mohamed, Ain Shams University

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


Condition or disease Intervention/treatment
Intra Uterine Growth Retardation 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

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Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Case-Control
Time Perspective: Prospective
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

Group/Cohort Intervention/treatment
level of placenta growth factor in IUGR Diagnostic Test: placenta growth factor
estimation level of derum placenta growth factor




Primary Outcome Measures :
  1. Birth weight below 10th percentile will be calculated as the primary outcome. [ Time Frame: 2 month ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.
Criteria

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


Information from the National Library of Medicine

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


Locations
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Egypt
Ain Sahms University
Cairo, Egypt
Sponsors and Collaborators
amera mohamed

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Responsible Party: amera mohamed, professor, Ain Shams University
ClinicalTrials.gov Identifier: NCT03350399    
Other Study ID Numbers: asamy
First Posted: November 22, 2017    Key Record Dates
Last Update Posted: November 22, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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
Additional relevant MeSH terms:
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Fetal Growth Retardation
Fetal Diseases
Pregnancy Complications
Growth Disorders
Pathologic Processes
Mitogens
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action