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Cell-free Fetal DNA Concentration in Cases of Abnormal Placental Invasion .

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ClinicalTrials.gov Identifier: NCT03638024
Recruitment Status : Recruiting
First Posted : August 20, 2018
Last Update Posted : October 9, 2018
Sponsor:
Information provided by (Responsible Party):
Dr- dina yahia mansour, Ain Shams Maternity Hospital

Tracking Information
First Submitted Date May 9, 2018
First Posted Date August 20, 2018
Last Update Posted Date October 9, 2018
Actual Study Start Date September 1, 2018
Estimated Primary Completion Date March 3, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 5, 2018)
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
Original Primary Outcome Measures
 (submitted: August 17, 2018)
Predictive value of maternal plasma cell free DNA [ Time Frame: 4 months ]
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. 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. Medical
Change History Complete list of historical versions of study NCT03638024 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: October 5, 2018)
maternal morbidity [ Time Frame: 4 months ]
maternal morbidity
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Cell-free Fetal DNA Concentration in Cases of Abnormal Placental Invasion .
Official Title Predictive Value of Cell-free Fetal DNA Concentration in the Maternal Plasma for Abnormal Placental Invasion in Cases of Placenta Previa.
Brief Summary Cell free fetal DNA might predict abnormal placental invasion
Detailed Description This study aims to evaluate whether measurement of cell-free fetal DNA in the maternal plasma can be predictive of abnormal invasion in cases of placenta previa.
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population 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).
Condition
  • Placenta Accreta
  • Placenta Percreta
  • Placenta Increta
  • Placenta Previa
Intervention Diagnostic Test: Maternal plasma cell free fetal DNA levels
Measurement Maternal plasma cell free fetal DNA levels in both groups (study and control groups)
Study Groups/Cohorts
  • 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).
    Intervention: Diagnostic Test: Maternal plasma cell free fetal DNA levels
  • 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.
    Intervention: Diagnostic Test: Maternal plasma cell free fetal DNA levels
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: August 17, 2018)
50
Original Estimated Enrollment Same as current
Estimated Study Completion Date April 3, 2019
Estimated Primary Completion Date March 3, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion criteria:

  1. Maternal age range from 20-40 years old.
  2. Parity: para 1- para 5.
  3. Body mass index range from 18-25 kg/m2.
  4. Singleton pregnancy carrying male fetuses.
  5. Gestational age range from 28-34 weeks.

Exclusion criteria:

  1. Multifetal pregnancy.
  2. Hypertension, preterm labor and intrauterine growth restriction.
  3. 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.
  4. Accidental hemorrhage.
Sex/Gender
Sexes Eligible for Study: Female
Ages 20 Years to 40 Years   (Adult)
Accepts Healthy Volunteers Not Provided
Contacts
Listed Location Countries Egypt
Removed Location Countries  
 
Administrative Information
NCT Number NCT03638024
Other Study ID Numbers Cell free fetal DNA
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Dr- dina yahia mansour, Ain Shams Maternity Hospital
Study Sponsor Ain Shams Maternity Hospital
Collaborators Not Provided
Investigators Not Provided
PRS Account Ain Shams Maternity Hospital
Verification Date October 2018