Placenta AccretaNCT03032770
Early Prediction of Placenta Accreta by Ultrasound and Color Doppler
An observational study of Placenta Accreta, run by Assiut University at 1 site in Egypt.
Trial summary
Placenta accreta is a substantially life threatening condition and one of the causes of maternal morbidity and mortality in the world. According to study done in United Kingdom, The estimated incidence of placenta accreta/increta/percreta was 1.7 per 10,000 maternities overall and 577 per 10,000 in women with both a… Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Placenta Accreta
- What is being tested?
- two-dimensional ultrasound and color Doppler
- Type of treatment
- Medical device
- How many people
- 148 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2017to 31 Mar 2020
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: first trimester pregnancy between 11 weeks and 13 weeks.
Who may be able to join
- Low implantation of the gestational sac (<4 cm from external os) by transvaginal ultrasound
- Presence of placental lakes by transvaginal ultrasound
- Disruption of placental-myometrial interface by transvaginal ultrasound
- Trophoblast overlapping a uterine scar (Cesarean section, myomectomy) by transvaginal ultrasound
- Intraplacental dilated vessels by Doppler ultrasound
- Turbulent blood flows by Doppler ultrasound
- Greatly increased periplacental vascularity by Doppler ultrasound
Who cannot join
- Cases far away from our hospital and expected to be lost to be followed. b) Pregnant women who will refuse to Participate
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Early Prediction of Placenta Accreta by 2 Dimensional Transvaginal Ultrasound and Color Doppler
Placenta accreta is a substantially life threatening condition and one of the causes of maternal morbidity and mortality in the world. According to study done in United Kingdom, The estimated incidence of placenta accreta/increta/percreta was 1.7 per 10,000 maternities overall and 577 per 10,000 in women with both a previous cesarean delivery and placenta previa. in a tertiary south Italian center, The incidence increased from 0.12% during the 1970s, to 0.31% during the 2000s.While in United States of America, the prevalence of placenta accreta was 3.7 per 1000 deliveries.
- Conditions
- Placenta Accreta
- Being tested
- two-dimensional ultrasound and color Doppler
- Medical subject headings
- Placenta Accreta
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
two-dimensional ultrasound and color DopplerDevice
the eligible participants will be searched for signs suggestive of placenta accreta; low implantation of the gestational sac (<4cm from the external os), presence of placental lakes, Disruption of placental-myometrial interface and trophoblast overlapping a uterine scar by 2 dimensional transvaginal ultrasound and Intraplacental dilated vessels, turbulent blood flows and greatly increased periplacental vascularity by Doppler ultrasound by level II sonographer and co-investigator under his supervision using ultrasound device.
| Study group | Role | What they receive |
|---|---|---|
| placenta accreta | Having at least one sign suggestive of placenta accreta Receives: Device: two-dimensional ultrasound and color Doppler | |
| normal placenta | Never having any of the signs suggestive of placenta accreta Receives: Device: two-dimensional ultrasound and color Doppler |
What is being measured
The primary outcome is the main question the study is designed to answer.
Confirmation of occurrence of placenta accreta during delivery.
Measured: duration of pregnancy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2017 (estimated)
- Study start1 Jan 2017
- Primary completion31 Dec 2019
- Study completion31 Mar 2020
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.
- More trials run by Assiut 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
- 148 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Mohamed Abbas, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03032770
- Sponsor's protocol ID
- USPA
- Status last verified
- May 2020
- First submitted
- 24 Jan 2017
- Last updated
- 13 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Prediction of Placenta Accreta by 2 Dimensional Transvaginal Ultrasound and Color Doppler
- ClinicalTrials.gov ID
- NCT03032770
- Acronym / sponsor ID
- USPA
- Conditions
- Placenta Accreta
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 148 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Mar 2020 (actual)
- First posted
- 26 Jan 2017 (estimated)
- 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.
Placenta accreta is a substantially life threatening condition and one of the causes of maternal morbidity and mortality in the world. According to study done in United Kingdom, The estimated incidence of placenta accreta/increta/percreta was 1.7 per 10,000 maternities overall and 577 per 10,000 in women with both a previous cesarean delivery and placenta previa. in a tertiary south Italian center, The incidence increased from 0.12% during the 1970s, to 0.31% during the 2000s.While in United States of America, the prevalence of placenta accreta was 3.7 per 1000 deliveries.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| placenta accreta | – | Device: two-dimensional ultrasound and color DopplerHaving at least one sign suggestive of placenta accreta |
| normal placenta | – | Device: two-dimensional ultrasound and color DopplerNever having any of the signs suggestive of placenta accreta |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- first trimester pregnancy between 11 weeks and 13 weeks.
Key inclusion criteria (7 listed)
- Low implantation of the gestational sac (<4 cm from external os) by transvaginal ultrasound
- Presence of placental lakes by transvaginal ultrasound
- Disruption of placental-myometrial interface by transvaginal ultrasound
- Trophoblast overlapping a uterine scar (Cesarean section, myomectomy) by transvaginal ultrasound
- Intraplacental dilated vessels by Doppler ultrasound
Key exclusion criteria (2 listed)
- Cases far away from our hospital and expected to be lost to be followed. b) Pregnant women who will refuse to Participate
- -
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 |
|---|---|---|
| two-dimensional ultrasound and color Dopplerthe eligible participants will be searched for signs suggestive of placenta accreta; low implantation of the gestational sac (<4cm from the external os), presence of placental lakes, Disruption of placental-myometrial interface and trophoblast overlapping a uterine scar by 2 dimensional transvaginal ultrasound and Intraplacental dilated vessels, turbulent blood flows and greatly increased periplacental vascularity by Doppler ultrasound by level II sonographer and co-investigator under his supervision using ultrasound device. | Device | normal placenta, placenta accreta |
Primary outcome
Confirmation of occurrence of placenta accreta during delivery.
Time frame: duration of pregnancy
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 13 May 2020.
- Individual participant dataSharing planned: Undecided
Related trials for Placenta Accreta
Not yet recruitingObservational study
Placenta-Cervical Interface Angle for Predicting Placenta Accreta Spectrum Severity
Placenta Accreta Spectrum, Placenta Previa
Not yet recruitingObservational study
Hematological and Coagulation Markers in Predicting Placenta Accreta Spectrum in Placenta Previa
Placenta Accreta Spectrum, Placenta Previa
Not yet recruitingObservational study
Ultrasound Scoring System for Diagnosis and Prediction of Severity and Surgical Outcomes of Placenta Accreta Spectrum
Placenta Accreta, Third Trimester
Not yet recruitingObservational study
Total Lower Uterine Segmentectomy With Adjunctive Mechanical Towel Compression for the Surgical Management of Placenta Accreta Spectrum Disorders
Placenta Accreta Management
Recruiting
Comparison Between 3 Conservative Surgeries for Placenta Accreta Spectrum
Placenta Accreta Spectrum
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?
An observational study of Placenta Accreta, run by Assiut 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 7 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 13 May 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 occurrence of placenta accreta during delivery. (time frame: duration of pregnancy). 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 13 May 2020.