- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03638024
Cell-free Fetal DNA Concentration in Cases of Abnormal Placental Invasion .
Predictive Value of Cell-free Fetal DNA Concentration in the Maternal Plasma for Abnormal Placental Invasion in Cases of Placenta Previa.
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
-
-
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Cairo, Egypt
- Recruiting
- Ain Shams University, Maternity Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion criteria:
- Maternal age range from 20-40 years old.
- Parity: para 1- para 5.
- Body mass index range from 18-25 kg/m2.
- Singleton pregnancy carrying male fetuses.
- Gestational age range from 28-34 weeks.
Exclusion criteria:
- Multifetal pregnancy.
- Hypertension, preterm labor and intrauterine growth restriction.
Patients taking a tocolytic agent or those with uterine bleeding at or after blood sampling.
- Since these complications may increase the level of cell-free fetal DNA.
- Accidental hemorrhage.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Study group
Maternal plasma cell free fetal DNA levels will be measured in 25 women with one or more previous cesarean section and placenta previa anterior only or with ultrasound finding suggestive of placental adhesion or invasion (accreta , increta or percreta).
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Measurement Maternal plasma cell free fetal DNA levels in both groups (study and control groups)
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Control group
Maternal plasma cell free fetal DNA levels will be measured in 25 matched control with normally situated placenta without ultrasound finding suggestive of placental adhesion or invasion.
|
Measurement Maternal plasma cell free fetal DNA levels in both groups (study and control groups)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Predictive value of maternal plasma cell free DNA
Time Frame: 4 months
|
Prediction of abnormal placental invasion in cases of placenta previa. Primary aim: Is to evaluate whether measurement of cell-free fetal DNA in the maternal plasma can be predictive of abnormal placental invasion in cases of placenta previa. Secondary aim: To decrease maternal morbidity and mortality by early prenatal diagnosis of abnormal placental invasion in placenta previa |
4 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
maternal morbidity
Time Frame: 4 months
|
maternal morbidity
|
4 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Cell free fetal DNA
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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