Placenta Accreta, Third TrimesterNCT03813212
Magnetic Resonance Imaging (MRI ) Versus Ultrasound in Placenta Accreta Diagnosis
An observational study of Placenta Accreta, Third Trimester, run by Ain Shams University at 1 site in Egypt.
Trial summary
This study aim to assess the accuracy of magnetic resonance imaging (MRI) compared to gray-scale and colour Doppler ultrasound (US) for the prenatal diagnosis of placenta accreta. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Placenta Accreta, Third Trimester
- What is being tested?
- MRI
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2019to Jan 2021
- 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: Haemodynamically stable pregnant women, who attend the antenatal care clinic at Ain Shams University Hospital or are referred from other hospitals for further evaluation. The recruited patients have to fulfill the inclusion criteria,
Who may be able to join
- Haemodynamically stable pregnant women who have the following risk factors for placenta accreta : persistent anterior placenta previa, prior uterine surgery (such as a previous cesarean section, uterine curettage, or myomectomy).
- Maternal age : 20-40 years old.
- BMI : 18-29.9 kg/m2.
Who cannot join
- Exclusion criteria will be MRI contraindications, cardiac pacemaker, metal objects in the body, and patient's refusal for MRI evaluation.
- Haemodynamically unstable patients.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of medicine ainshams university
Cairo, 11865
Safaa Thabet, 01157514436, remystar763@yahoo.com
Malames Faisal, 01098958995, Misofaisal@yahoo.co.uk
About this study
Official title: Gray-scale , Colour Doppler Ultrasound and Magnetic Resonance Imaging for Diagnosis of Placenta Accreta
This study aim to assess the accuracy of magnetic resonance imaging (MRI) compared to gray-scale and colour Doppler ultrasound (US) for the prenatal diagnosis of placenta accreta.
Read the detailed description
Placenta accreta occurs when the chorionic villi abnormally invade the myometrium. Based on histopathology it is divided into three grades: placenta accreta (the chorionic villi are in contact with the myometrium), placenta increta (the chorionic villi invade the myometrium), and placenta percreta where the chorionic villi penetrate the uterine serosa. With increasing rate of cesarean delivery, the incidence of both placenta praevia and placenta accreta is steadily increasing in frequency.
Prenatal diagnosis of invasive placentation is associated with a reduced risk of maternal complications as it allows a preplanned treatment of the condition . Gray-scale and colour Doppler ultrasound (US) are valuable tools in the prenatal diagnosis of placenta accreta .However, if the ultrasound ( US ) findings suggest possible percreta or are inconclusive or negative in an at-risk woman, magnetic resonance imaging (MRI) can be useful.
Multiple sonographic findings are seen with placenta accreta such as decrease in myometrial thickness, placenta previa, placental lacunae, abnormal pattern of color Doppler, loss of the retroplacental clear zone and placenta percreta irregularities in wall of urinary bladder ( UB ) have been detected .
The most magnetic resonance imaging characteristic findings seen in placenta accreta are nodular thickening in the dark zone of placenta-uterine interface together with extensions of dark bands through the placenta, outer uterine bulge causing from the mass effect of the placenta and heterogeneous signal intensity of placenta on the T2-weighted HASTE sequences due to large placental lakes and vessels.
- Conditions
- Placenta Accreta, Third Trimester
- Being tested
- MRI
- Medical subject headings
- Placenta Accreta
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRIDevice
Also called Ultrasound
Magnetic resonance imaging. Trans-abdominal sonography (TAS) and transvaginal sonography (TVS) will be performed using a 3.5 or 5 MHz transabdominal convex transducer and a 7 MHz trans-vaginal transducer.
What is being measured
The primary outcome is the main question the study is designed to answer.
Determination of degree of placental invasion
Determination of degree of placental invasion by comparing the results obtained by ultrasound , MRI with the final pathological examination after operation ( the excised part of myometrium with the attached placenta or hysterectomy specimen ).
Measured: Baseline
Secondary outcomes (1)
Change Maternal morbidity and mortality
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2019
- Study start1 Jan 2019
- Primary completionJan 2021 (estimated)
- Study completionJan 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Placenta Accreta, Third TrimesterStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Safaa thabet abd El Aziz Ahmed, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03813212
- Sponsor's protocol ID
- MRI placenta accreta
- Status last verified
- Jul 2020
- First submitted
- 17 Nov 2018
- Last updated
- 17 Jul 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Lopes ES, Feitosa FEL, Brazil AV, de Castro JDV, da Costa JIF, Araujo Junior E, Peixoto AB, Carvalho FHC. Assessment of Sensitivity and Specificity of Ultrasound and Magnetic Resonance Imaging in the Diagnosis of Placenta Accreta. Rev Bras Ginecol Obstet. 2019 Jan;41(1):17-23. doi: 10.1055/s-0038-1675803. Epub 2018 Nov 14.
PubMed 30428490Haunschild C, Yeaton-Massey A, Lyell DJ. Antenatal Management of Placenta Accreta. Clin Obstet Gynecol. 2018 Dec;61(4):766-773. doi: 10.1097/GRF.0000000000000394.
PubMed 30204620
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gray-scale , Colour Doppler Ultrasound and Magnetic Resonance Imaging for Diagnosis of Placenta Accreta
- ClinicalTrials.gov ID
- NCT03813212
- Acronym / sponsor ID
- MRI placenta accreta
- Conditions
- Placenta Accreta, Third Trimester
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- Jan 2021 (estimated)
- Study completion
- Jan 2021 (estimated)
- First posted
- 23 Jan 2019 (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.
This study aim to assess the accuracy of magnetic resonance imaging (MRI) compared to gray-scale and colour Doppler ultrasound (US) for the prenatal diagnosis of placenta accreta.
Detailed description
Placenta accreta occurs when the chorionic villi abnormally invade the myometrium. Based on histopathology it is divided into three grades: placenta accreta (the chorionic villi are in contact with the myometrium), placenta increta (the chorionic villi invade the myometrium), and placenta percreta where the chorionic villi penetrate the uterine serosa. With increasing rate of cesarean delivery, the incidence of both placenta praevia and placenta accreta is steadily increasing in frequency.
Prenatal diagnosis of invasive placentation is associated with a reduced risk of maternal complications as it allows a preplanned treatment of the condition . Gray-scale and colour Doppler ultrasound (US) are valuable tools in the prenatal diagnosis of placenta accreta .However, if the ultrasound ( US ) findings suggest possible percreta or are inconclusive or negative in an at-risk woman, magnetic resonance imaging (MRI) can be useful.
Multiple sonographic findings are seen with placenta accreta such as decrease in myometrial thickness, placenta previa, placental lacunae, abnormal pattern of color Doppler, loss of the retroplacental clear zone and placenta percreta irregularities in wall of urinary bladder ( UB ) have been detected .
The most magnetic resonance imaging characteristic findings seen in placenta accreta are nodular thickening in the dark zone of placenta-uterine interface together with extensions of dark bands through the placenta, outer uterine bulge causing from the mass effect of the placenta and heterogeneous signal intensity of placenta on the T2-weighted HASTE sequences due to large placental lakes and vessels.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- Haemodynamically stable pregnant women, who attend the antenatal care clinic at Ain Shams University Hospital or are referred from other hospitals for further evaluation. The recruited patients have to fulfill the inclusion criteria,
Key inclusion criteria (3 listed)
- Haemodynamically stable pregnant women who have the following risk factors for placenta accreta : persistent anterior placenta previa, prior uterine surgery (such as a previous cesarean section, uterine curettage, or myomectomy).
- Maternal age : 20-40 years old.
- BMI : 18-29.9 kg/m2.
Key exclusion criteria (2 listed)
- Exclusion criteria will be MRI contraindications, cardiac pacemaker, metal objects in the body, and patient's refusal for MRI evaluation.
- Haemodynamically unstable patients.
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 |
|---|---|---|
| MRIAlso: UltrasoundMagnetic resonance imaging. Trans-abdominal sonography (TAS) and transvaginal sonography (TVS) will be performed using a 3.5 or 5 MHz transabdominal convex transducer and a 7 MHz trans-vaginal transducer. | Device | – |
Primary outcome
Determination of degree of placental invasion
Time frame: Baseline
Determination of degree of placental invasion by comparing the results obtained by ultrasound , MRI with the final pathological examination after operation ( the excised part of myometrium with the attached placenta or hysterectomy specimen ).
1 secondary outcome
Change Maternal morbidity and mortality
Time frame: Baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2020.
- Background: PubMed 30428490Lopes ES, Feitosa FEL, Brazil AV, de Castro JDV, da Costa JIF, Araujo Junior E, Peixoto AB, Carvalho FHC. Assessment of Sensitivity and Specificity of Ultrasound and Magnetic Resonance Imaging in the Diagnosis of Placenta Accreta. Rev Bras Ginecol Obstet. 2019 Jan;41(1):17-23. doi: 10.1055/s-0038-1675803. Epub 2018 Nov 14.
- Background: PubMed 30204620Haunschild C, Yeaton-Massey A, Lyell DJ. Antenatal Management of Placenta Accreta. Clin Obstet Gynecol. 2018 Dec;61(4):766-773. doi: 10.1097/GRF.0000000000000394.
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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, Third Trimester, run by Ain Shams University 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 3 inclusion and 2 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 17 Jul 2020. 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?
Contact Safaa Thabet, M.B.B.,Ch (01067593438, Safaathabet63@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determination of degree of placental invasion (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03813212, which also lists 2 linked publications.
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 17 Jul 2020.