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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

Brief Summary:
Cell free fetal DNA might predict abnormal placental invasion

Condition or disease Intervention/treatment
Placenta Accreta Placenta Percreta Placenta Increta Placenta Previa Diagnostic Test: Maternal plasma cell free fetal DNA levels

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.

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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Predictive Value of Cell-free Fetal DNA Concentration in the Maternal Plasma for Abnormal Placental Invasion in Cases of Placenta Previa.
Actual Study Start Date : September 1, 2018
Estimated Primary Completion Date : March 3, 2019
Estimated Study Completion Date : April 3, 2019

Resource links provided by the National Library of Medicine


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).
Diagnostic Test: Maternal plasma cell free fetal DNA levels
Measurement Maternal plasma cell free fetal DNA levels in both groups (study and control groups)

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.
Diagnostic Test: Maternal plasma cell free fetal DNA levels
Measurement Maternal plasma cell free fetal DNA levels in both groups (study and control groups)




Primary Outcome Measures :
  1. 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



Secondary Outcome Measures :
  1. maternal morbidity [ Time Frame: 4 months ]
    maternal morbidity



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Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
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).
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.

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): NCT03638024


Locations
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Egypt
Ain Shams University, Maternity Hospital Recruiting
Cairo, Egypt
Contact: Dina Mansour    +20100657    Dinayahiamansour@hotmail.com   
Sponsors and Collaborators
Ain Shams Maternity Hospital

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Responsible Party: Dr- dina yahia mansour, Lecturer of Obstetrics and Gynecology Ain Shams University, Ain Shams Maternity Hospital
ClinicalTrials.gov Identifier: NCT03638024     History of Changes
Other Study ID Numbers: Cell free fetal DNA
First Posted: August 20, 2018    Key Record Dates
Last Update Posted: October 9, 2018
Last Verified: October 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Placenta Previa
Placenta Accreta
Obstetric Labor Complications
Pregnancy Complications
Placenta Diseases