Antepartum HemorrhageNCT03267446
Doppler Imaging and Morbidly Adherent Placenta
A study testing 3D Doppler Ultrasound in people with Antepartum Hemorrhage, run by Cairo University at 1 site in Egypt.
Trial summary
The aim of this study is to assess the value of adding 3D power Doppler (as a diagnostic technique) to gray scale technique in the antenatal diagnosis of morbidly adherent placenta as well as predict the surgical outcome regarding the type of surgery and the intra operative morbidities. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Antepartum Hemorrhage
- What is being tested?
- 3D Doppler Ultrasound
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 29 Aug 2017to 1 Sep 2018
- 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
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age: 18 - 45.
- Pregnant 32 weeks or more.
- Placenta previa (Major and Minor).
- History of previous cesarean section.
Who cannot join
- Medical disorders such as bleeding disorders.
- Lethal fetal anomalies.
- Delivery before 34 weeks.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Kasr el aini hospital
Cairo, 12211
Ahmed M Hussein, MD, 01223515652 ext. 002, ahmed_mhussein@live.com
About this study
Official title: The Role of Grey Scale Ultrasound, 2D, and 3D Power Doppler in Diagnosing and Predicting the Surgical Risks in Patients With Morbidly Adherent Placenta.
The aim of this study is to assess the value of adding 3D power Doppler (as a diagnostic technique) to gray scale technique in the antenatal diagnosis of morbidly adherent placenta as well as predict the surgical outcome regarding the type of surgery and the intra operative morbidities.
- Conditions
- Antepartum Hemorrhage
- Being tested
- 3D Doppler Ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3D Doppler UltrasoundDevice
3D volumes will be obtained in automatic sweeps using a motorized curved-array transducer while the women held their breath. In order to interpret the data consistently, the settings of power, On Voluson E10; GE Medical Systems)
| Study group | Role | What they receive |
|---|---|---|
| Interventional group | Experimental | Patients confirmed having one or more of the signs of morbidly adherent placenta will be examined by 3D Ultrasound and 3D power Doppler. Patients will then be prepared for the operation.Cesarean hysterectomy will be done with removal of the uterus and the placenta as one mass.Cases with focal invasion of the uterus will be given a trial for conservative management. The whole specimen will be sent for histopathological examination, and the determination of length and depth of invasion. Receives: Device: 3D Doppler Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity of 3D power Doppler in detecting morbidly adherent placenta.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2017
- Study start29 Aug 2017
- Primary completion1 Sep 2018 (estimated)
- Study completion1 Sep 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Antepartum HemorrhageStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Mahmoud Hussein, Cairo University
- Investigators
- Ahmed M Hussein, MD, Principal investigator, Cairo Univeristy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03267446
- Sponsor's protocol ID
- CU28817
- Status last verified
- Aug 2017
- First submitted
- 29 Aug 2017
- Last updated
- 30 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Grey Scale Ultrasound, 2D, and 3D Power Doppler in Diagnosing and Predicting the Surgical Risks in Patients With Morbidly Adherent Placenta.
- ClinicalTrials.gov ID
- NCT03267446
- Acronym / sponsor ID
- CU28817
- Conditions
- Antepartum Hemorrhage
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 29 Aug 2017 (actual)
- Primary completion
- 1 Sep 2018 (estimated)
- Study completion
- 1 Sep 2018 (estimated)
- First posted
- 30 Aug 2017 (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 aim of this study is to assess the value of adding 3D power Doppler (as a diagnostic technique) to gray scale technique in the antenatal diagnosis of morbidly adherent placenta as well as predict the surgical outcome regarding the type of surgery and the intra operative morbidities.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Interventional group | Experimental | Device: 3D Doppler UltrasoundPatients confirmed having one or more of the signs of morbidly adherent placenta will be examined by 3D Ultrasound and 3D power Doppler. Patients will then be prepared for the operation.Cesarean hysterectomy will be done with removal of the uterus and the placenta as one mass.Cases with focal invasion of the uterus will be given a trial for conservative management. The whole specimen will be sent for histopathological examination, and the determination of length and depth of invasion. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age: 18 - 45.
- Pregnant 32 weeks or more.
- Placenta previa (Major and Minor).
- History of previous cesarean section.
Key exclusion criteria (3 listed)
- Medical disorders such as bleeding disorders.
- Lethal fetal anomalies.
- Delivery before 34 weeks.
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 |
|---|---|---|
| 3D Doppler Ultrasound3D volumes will be obtained in automatic sweeps using a motorized curved-array transducer while the women held their breath. In order to interpret the data consistently, the settings of power, On Voluson E10; GE Medical Systems) | Device | Interventional group |
Primary outcome
Sensitivity of 3D power Doppler in detecting morbidly adherent placenta.
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2017.
- Individual participant dataSharing planned: Undecided
Related trials for Antepartum Hemorrhage
Recruiting
Planned Delivery at 37 Versus 36 Weeks in Pregnancies With Placenta Previaand Accreta
Placenta Previa, 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.
Ahmed M Hussein, MD principal investigator
Cairo Univeristy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3D Doppler Ultrasound in people with Antepartum Hemorrhage, run by Cairo 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 4 inclusion and 3 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 30 Aug 2017. 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 Ahmed M Hussein, MD (01223 515652 ext. 002, ahmed_mhussein@live.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity of 3D power Doppler in detecting morbidly adherent placenta. (time frame: 12 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 30 Aug 2017.