Obstetric Labor ComplicationsNCT04253197
Ultrasound Staging in the Placenta Accreta
A study testing Ultrasound in people with Obstetric Labor Complications and Staging of Placental Invasion, run by Beni-Suef University at 1 site in Egypt.
Trial summary
The investigators evaluated the efficacy of a staging system introduced by the American Institute of ultrasound in medicine 2015 including sonographic parameters associated with morbidly adherent placenta for antenatal prediction of placental invasion. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Obstetric Labor Complications, Staging of Placental Invasion
- What is being tested?
- Ultrasound
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteEgypt
- Study dates
- 14 Mar 2017to 25 Dec 2019
- Phase
- Interventional
- 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 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Prior lower segment cesarean section
- Low lying anterior placenta
- Singleton pregnancy
Who cannot join
- Medical disorders
- vasa previa
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Ultrasound Staging System in Prediction of Morbidly Adherent Placenta
The investigators evaluated the efficacy of a staging system introduced by the American Institute of ultrasound in medicine 2015 including sonographic parameters associated with morbidly adherent placenta for antenatal prediction of placental invasion.
Read the detailed description
Morbidly adherent placenta (MAP) defines a spectrum of conditions, including placenta accreta, increta, and percreta, which are associated with significant maternal and fetal morbidity and mortality. Ultrasound evaluation, with grayscale, is the recommended first-line modality for diagnosing MAP. Grayscale ultrasound features suggestive of placenta accreta include the loss of myometrial interface or retroplacental clear space, reduced myometrial thickness and the presence of intraplacental lacunae. Using a staging system by antenatal ultrasound can predict placental invasion antenatally.
- Being tested
- Ultrasound
- Medical subject headings
- Obstetric Labor Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UltrasoundDevice
Pregnant women in 3rd trimester with anterior placenta previa and lower cesarean section scar. Ultrasound was done and according to parameters of the morbidly adherent placenta, a staging system was conducted.
| Study group | Role | What they receive |
|---|---|---|
| Morbidly adherent placenta | Other | This arm was given stage according to ultrasound features. Receives: Device: Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Confirmation of the stage of myometrial placental invasion
By ultrasound, placental invasion in myometrium was given a stage
Measured: 1 hour
Secondary outcomes (1)
Blood loss
Documentation of complications intraoperative
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2020
- Study start14 Mar 2017
- Primary completion20 Jul 2019
- Study completion25 Dec 2019
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 Obstetric Labor ComplicationsStudies of the same condition, open and under way.
- More trials run by Beni-Suef 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Pregnant women in 3rd trimester
- Masking
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beni-Suef University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nesreen Abdel Fattah Abdullah Shehata, Beni-Suef University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04253197
- Sponsor's protocol ID
- Beni-Suef 3-2017
- Status last verified
- Jan 2020
- First submitted
- 30 Jan 2020
- Last updated
- 5 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Albayrak M, Ozdemir I, Koc O, Demiraran Y. Post-partum haemorrhage from the lower uterine segment secondary to placenta praevia/accreta: successful conservative management with Foley balloon tamponade. Aust N Z J Obstet Gynaecol. 2011 Aug;51(4):377-80. doi: 10.1111/j.1479-828X.2011.01309.x. Epub 2011 Apr 18.
PubMed 21806571American institute of ultrasound in medicine 2015.
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Ultrasound Staging System in Prediction of Morbidly Adherent Placenta
- ClinicalTrials.gov ID
- NCT04253197
- Acronym / sponsor ID
- Beni-Suef 3-2017
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Beni-Suef UniversityUniversity, hospital or other
- Study start
- 14 Mar 2017 (actual)
- Primary completion
- 20 Jul 2019 (actual)
- Study completion
- 25 Dec 2019 (actual)
- First posted
- 5 Feb 2020 (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.
The investigators evaluated the efficacy of a staging system introduced by the American Institute of ultrasound in medicine 2015 including sonographic parameters associated with morbidly adherent placenta for antenatal prediction of placental invasion.
Detailed description
Morbidly adherent placenta (MAP) defines a spectrum of conditions, including placenta accreta, increta, and percreta, which are associated with significant maternal and fetal morbidity and mortality. Ultrasound evaluation, with grayscale, is the recommended first-line modality for diagnosing MAP. Grayscale ultrasound features suggestive of placenta accreta include the loss of myometrial interface or retroplacental clear space, reduced myometrial thickness and the presence of intraplacental lacunae. Using a staging system by antenatal ultrasound can predict placental invasion antenatally.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Pregnant women in 3rd trimester
| Arm | Type | Receives |
|---|---|---|
| Morbidly adherent placenta | Other | Device: UltrasoundThis arm was given stage according to ultrasound features. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Prior lower segment cesarean section
- Low lying anterior placenta
- Singleton pregnancy
Key exclusion criteria (2 listed)
- Medical disorders
- vasa previa
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 |
|---|---|---|
| UltrasoundPregnant women in 3rd trimester with anterior placenta previa and lower cesarean section scar. Ultrasound was done and according to parameters of the morbidly adherent placenta, a staging system was conducted. | Device | Morbidly adherent placenta |
Primary outcome
Confirmation of the stage of myometrial placental invasion
Time frame: 1 hour
By ultrasound, placental invasion in myometrium was given a stage
1 secondary outcome
Blood loss
Time frame: 1 hour
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2020.
- Background: PubMed 21806571Albayrak M, Ozdemir I, Koc O, Demiraran Y. Post-partum haemorrhage from the lower uterine segment secondary to placenta praevia/accreta: successful conservative management with Foley balloon tamponade. Aust N Z J Obstet Gynaecol. 2011 Aug;51(4):377-80. doi: 10.1111/j.1479-828X.2011.01309.x. Epub 2011 Apr 18.
- BackgroundAmerican institute of ultrasound in medicine 2015.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound in people with Obstetric Labor Complications and Staging of Placental Invasion, run by Beni-Suef 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: finished, as of the sponsor's last update on 5 Feb 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Confirmation of the stage of myometrial placental invasion (time frame: 1 hour). 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 NCT04253197, 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 5 Feb 2020.