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

October 5, 2018 updated by: Dr- dina yahia mansour, Ain Shams Maternity Hospital

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

Cell free fetal DNA might predict abnormal placental invasion

Study Overview

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

Enrollment (Anticipated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Cairo, Egypt
        • Recruiting
        • Ain Shams University, Maternity Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 40 years (ADULT)

Accepts Healthy Volunteers

N/A

Genders 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).

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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).
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.
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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
maternal morbidity
Time Frame: 4 months
maternal morbidity
4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 1, 2018

Primary Completion (ANTICIPATED)

March 3, 2019

Study Completion (ANTICIPATED)

April 3, 2019

Study Registration Dates

First Submitted

May 9, 2018

First Submitted That Met QC Criteria

August 17, 2018

First Posted (ACTUAL)

August 20, 2018

Study Record Updates

Last Update Posted (ACTUAL)

October 9, 2018

Last Update Submitted That Met QC Criteria

October 5, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • Cell free fetal DNA

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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