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

Placenta Accreta Clinical Trial

Official title:

Predictive Value of Cell-free Fetal DNA Concentration in the Maternal Plasma for Abnormal Placental Invasion in Cases of Placenta Previa.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03638024
• Other study ID #: Cell free fetal DNA
• Status: Recruiting
• Start date: September 1, 2018
• Est. completion date: April 3, 2019

Study information

• Verified date: October 2018
• Source: Ain Shams Maternity Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Cell free fetal DNA might predict abnormal placental invasion

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: April 3, 2019
• Est. primary completion date: March 3, 2019
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Placenta Accreta
• Placenta Increta
• Placenta Percreta
• 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)

Locations

Country	Name	City	State
Egypt	Ain Shams University, Maternity Hospital	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams Maternity Hospital

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	maternal morbidity	maternal morbidity	4 months