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

NCT ID: NCT03638024

Last Updated: 2018-10-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-09-01

Study Completion Date

2019-04-03

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Cell free fetal DNA might predict abnormal placental invasion

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Placenta Accreta Placenta Percreta Placenta Increta Placenta Previa

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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).

Maternal plasma cell free fetal DNA levels

Intervention Type DIAGNOSTIC_TEST

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.

Maternal plasma cell free fetal DNA levels

Intervention Type DIAGNOSTIC_TEST

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Maternal plasma cell free fetal DNA levels

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Ain Shams Maternity Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Dr- dina yahia mansour

Lecturer of Obstetrics and Gynecology Ain Shams University

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Ain Shams University, Maternity Hospital

Cairo, , Egypt

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Egypt

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Dina Mansour

Role: primary

+20100657

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Cell free fetal DNA

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.