Placenta AccretaNCT03638024
Cell-free Fetal DNA Concentration in Cases of Abnormal Placental Invasion .
An observational study of Placenta Accreta and Placenta Percreta, run by Ain Shams Maternity Hospital at 1 site in Egypt.
Trial summary
Cell free fetal DNA might predict abnormal placental invasion Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Placenta Accreta, Placenta Percreta, Placenta Increta
- What is being tested?
- Maternal plasma cell free fetal DNA levels
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2018to 3 Apr 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- Women only
- Adult
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).
Who may be able to join
- Maternal age range from 20-40 years old.
- Parity: para 1- para 5.
- Body mass index range from 18-25 kg/m2.
- Singleton pregnancy carrying male fetuses.
- Gestational age range from 28-34 weeks.
Who cannot join
- Multifetal pregnancy.
- Hypertension, preterm labor and intrauterine growth restriction.
- 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.
- Accidental hemorrhage.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Ain Shams University, Maternity Hospital
Cairo
Dina Mansour, +20100657, Dinayahiamansour@hotmail.com
About this study
Official title: 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
Read the 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.
- Conditions
- Placenta Accreta, Placenta Percreta, Placenta Increta, Placenta Previa
- Being tested
- Maternal plasma cell free fetal DNA levels
- Medical subject headings
- Placenta Accreta, Placenta Previa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Maternal plasma cell free fetal DNA levelsDiagnostic test
Measurement Maternal plasma cell free fetal DNA levels in both groups (study and control groups)
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. Receives: Diagnostic Test: Maternal plasma cell free fetal DNA levels |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 4 months
Secondary outcomes (1)
maternal morbidity
maternal morbidity
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2018
- Study start1 Sep 2018
- Primary completion3 Mar 2019 (estimated)
- Study completion3 Apr 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Placenta AccretaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams Maternity Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr- dina yahia mansour, Ain Shams Maternity Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03638024
- Sponsor's protocol ID
- Cell free fetal DNA
- Status last verified
- Oct 2018
- First submitted
- 9 May 2018
- Last updated
- 9 Oct 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive Value of Cell-free Fetal DNA Concentration in the Maternal Plasma for Abnormal Placental Invasion in Cases of Placenta Previa.
- ClinicalTrials.gov ID
- NCT03638024
- Acronym / sponsor ID
- Cell free fetal DNA
- Conditions
- Placenta Accreta, Placenta Percreta, Placenta Increta, Placenta Previa
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Ain Shams Maternity HospitalUniversity, hospital or other
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 3 Mar 2019 (estimated)
- Study completion
- 3 Apr 2019 (estimated)
- First posted
- 20 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study group | – | Diagnostic Test: Maternal plasma cell free fetal DNA levelsMaternal 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). |
| Control group | – | Diagnostic Test: Maternal plasma cell free fetal DNA levelsMaternal 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. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Age groups
- Adult
- 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).
Key inclusion criteria (5 listed)
- Maternal age range from 20-40 years old.
- Parity: para 1- para 5.
- Body mass index range from 18-25 kg/m2.
- Singleton pregnancy carrying male fetuses.
- Gestational age range from 28-34 weeks.
Key exclusion criteria (5 listed)
- Multifetal pregnancy.
- Hypertension, preterm labor and intrauterine growth restriction.
- Patients taking a tocolytic agent or those with uterine bleeding at or after blood sampling.
- Accidental hemorrhage.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Maternal plasma cell free fetal DNA levelsMeasurement Maternal plasma cell free fetal DNA levels in both groups (study and control groups) | Diagnostic test | Control group, Study group |
Primary outcome
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
1 secondary outcome
maternal morbidity
Time frame: 4 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Placenta Accreta and Placenta Percreta, run by Ain Shams Maternity Hospital at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Predictive value of maternal plasma cell free DNA (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2018.