CClinicalTrials.gg
Status unknownNCT03638024Updated Oct 9, 2018

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

An observational study in Placenta Accreta, Placenta Percreta and Placenta Increta, sponsored by Ain Shams Maternity Hospital. Status unknown at 1 site in Egypt. Open to female participants aged 20 Years to 40 Years. Per ClinicalTrials.gov, last updated 2018-10-09.

Sponsored by Ain Shams Maternity Hospital · Observational

The sponsor has not verified this record recently (last verified Oct 2018), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
50
Ages
20 Years to 40 Years
Sex
Female
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Study summary

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.

02

Conditions studied

  • Placenta Accreta
  • Placenta Percreta
  • Placenta Increta
  • Placenta Previa
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In context

Placenta Accreta

147 studies on the registry are indexed under Placenta Accreta; 39 are open to participants now.

This study's planned enrollment of 50 is below the median of 84 across 79 observational studies indexed under Placenta Accreta.

Browse Placenta Accreta studies →

Lead sponsor

Ain Shams Maternity Hospital is the lead sponsor of 135 studies on the registry; 7 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
20 Years to 40 Years
Sexes eligible
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).

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

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.
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Study design

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
50 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

  • 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

Interventions

  • Diagnostic testMaternal plasma cell free fetal DNA levels

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

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What researchers measure

Primary outcomes

  1. 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

    Time frame: 4 months

Secondary outcomes

  1. maternal morbidity

    maternal morbidity

    Time frame: 4 months

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Study locations

1 of 1 sites recruiting
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 9, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03638024
Lead sponsor
Ain Shams Maternity Hospital
Responsible party
Dr- dina yahia mansour (Lecturer of Obstetrics and Gynecology Ain Shams University, Ain Shams Maternity Hospital) — Principal investigator
First posted
Aug 20, 2018
Start date
Sep 1, 2018
Primary completion
Mar 3, 2019 (estimated)
Completion
Apr 3, 2019 (estimated)
Last update
Oct 9, 2018

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Oct 2018. You cannot join it, but the record below documents what was studied.

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