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.
1 other identifier
observational
50
1 country
1
Brief Summary
Cell free fetal DNA might predict abnormal placental invasion
Trial Health
Trial Health Score
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participants targeted
Target at P25-P50 for all trials
Started Sep 2018
Shorter than P25 for all trials
1 active site
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 9, 2018
CompletedFirst Posted
Study publicly available on registry
August 20, 2018
CompletedStudy Start
First participant enrolled
September 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 3, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
April 3, 2019
CompletedOctober 9, 2018
October 1, 2018
6 months
May 9, 2018
October 5, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Predictive value of maternal plasma cell free DNA
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
Secondary Outcomes (1)
maternal morbidity
4 months
Study Arms (2)
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).
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.
Interventions
Measurement Maternal plasma cell free fetal DNA levels in both groups (study and control groups)
Eligibility Criteria
Study group (1): 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).
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ain Shams University, Maternity Hospital
Cairo, Egypt
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Lecturer of Obstetrics and Gynecology Ain Shams University
Study Record Dates
First Submitted
May 9, 2018
First Posted
August 20, 2018
Study Start
September 1, 2018
Primary Completion
March 3, 2019
Study Completion
April 3, 2019
Last Updated
October 9, 2018
Record last verified: 2018-10