Placenta PreviaNCT04264234
Management Of Placenta Previa Cases And Determination Of Hospitalization Criteria
A study testing Vaginal Ultrasonography and Magnetic Resonance Imaging in people with Placenta Previa, run by Ege University at 1 site in Turkey (Türkiye).
Trial summary
Placenta previa cases are one of the difficult groups of patients to manage in modern obstetrics. When the literature is evaluated extensively, no clear information can be seen especially in terms of hospitalization time. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Placenta Previa
- What is being tested?
- Vaginal Ultrasonography and Magnetic Resonance Imaging
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 13 Nov 2018to 1 Feb 2020
- 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Monitoring of placenta previa
- To apply before the 28th week
- To have a low-risk second trimester screening test
- No malformation detected in the anomaly screening
Who cannot join
- Multiple pregnancies
- Pregnancy complicated with preeclampsia
- Pregnancy complicated by gestational hypertension
- Pregnancy complicated by gestational diabetes mellitus
Trial locations and contacts
1 site in 1 country.
About this study
Placenta previa cases are one of the difficult groups of patients to manage in modern obstetrics. When the literature is evaluated extensively, no clear information can be seen especially in terms of hospitalization time. Inpatient follow-up of this patients has negative effects like hospital infections in terms of the patient, workload in terms of health personnel and financial losses in terms of the country's economy. Placenta previa cases are complicated patients in which generalizations cannot be easily performed and they should be monitored at third level hospitals. In addition, care should be personalized considering the many reasons. In this study, placenta previa cases will be followed up at 28th gestational week and evaluated at 32nd week by vaginal ultrasonography and MRI and this follow-up will continue until delivery. Thus, in this study, it was aimed to determine the parameters that would allow systematic personalization of health service in this particular patient group by making risk assessment of placenta previa cases.
- Conditions
- Placenta Previa
- Being tested
- Vaginal Ultrasonography, Magnetic Resonance Imaging
- Keywords
- placenta previa, placental invasion anomalies, timing of the birth
- Medical subject headings
- Placenta Previa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vaginal UltrasonographyDiagnostic test
Placenta previa cases will be evaluated at 32nd week by vaginal ultrasonography for invasion anomaly and preterm birth.
Magnetic Resonance ImagingDiagnostic test
Placenta previa cases will be evaluated at 32nd week by MRI for invasion anomaly and preterm birth.
| Study group | Role | What they receive |
|---|---|---|
| Placenta Previa | Experimental | Placenta previa cases will be evaluated at 32nd week by vaginal ultrasonography and MRI. Receives: Diagnostic Test: Vaginal Ultrasonography; Diagnostic Test: Magnetic Resonance Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of placental invasion pathologies
Placental invasion pathologies detected during delivery will be evaluated.
Measured: 1 day
The number of preterm birth
The relation between preterm birth and placental invasion pathologies will be assessed.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2020
- Study start13 Nov 2018
- Primary completion1 Feb 2020
- Study completion1 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Placenta PreviaStudies of the same condition, open and under way.
- More trials run by Ege 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
- Placenta previa cases will be followed up at 28th gestational week and evaluated at 32nd week by vaginal ultrasonography and MRI and this follow-up will continue until delivery.
- Masking
- None (open label)
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ege University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sabahattin Anıl Arı, Ege University
- Investigators
- Sabahattin a Arı, MD, Principal investigator, Ege University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04264234
- Sponsor's protocol ID
- 18-9.1/27
- Status last verified
- Mar 2022
- First submitted
- 3 Nov 2018
- Last updated
- 23 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Management Of Placenta Previa Cases And Determination Of Hospitalization Criteria
- ClinicalTrials.gov ID
- NCT04264234
- Acronym / sponsor ID
- 18-9.1/27
- Conditions
- Placenta Previa
- Keywords
- placenta previa, placental invasion anomalies, timing of the birth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Ege UniversityUniversity, hospital or other
- Study start
- 13 Nov 2018 (actual)
- Primary completion
- 1 Feb 2020 (actual)
- Study completion
- 1 Feb 2020 (actual)
- First posted
- 11 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.
Placenta previa cases are one of the difficult groups of patients to manage in modern obstetrics. When the literature is evaluated extensively, no clear information can be seen especially in terms of hospitalization time. Inpatient follow-up of this patients has negative effects like hospital infections in terms of the patient, workload in terms of health personnel and financial losses in terms of the country's economy. Placenta previa cases are complicated patients in which generalizations cannot be easily performed and they should be monitored at third level hospitals. In addition, care should be personalized considering the many reasons. In this study, placenta previa cases will be followed up at 28th gestational week and evaluated at 32nd week by vaginal ultrasonography and MRI and this follow-up will continue until delivery. Thus, in this study, it was aimed to determine the parameters that would allow systematic personalization of health service in this particular patient group by making risk assessment of placenta previa cases.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Placenta previa cases will be followed up at 28th gestational week and evaluated at 32nd week by vaginal ultrasonography and MRI and this follow-up will continue until delivery.
| Arm | Type | Receives |
|---|---|---|
| Placenta Previa | Experimental | Diagnostic Test: Vaginal Ultrasonography, Diagnostic Test: Magnetic Resonance ImagingPlacenta previa cases will be evaluated at 32nd week by vaginal ultrasonography and MRI. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Monitoring of placenta previa
- To apply before the 28th week
- To have a low-risk second trimester screening test
- No malformation detected in the anomaly screening
Key exclusion criteria (4 listed)
- Multiple pregnancies
- Pregnancy complicated with preeclampsia
- Pregnancy complicated by gestational hypertension
- Pregnancy complicated by gestational diabetes mellitus
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 |
|---|---|---|
| Vaginal UltrasonographyPlacenta previa cases will be evaluated at 32nd week by vaginal ultrasonography for invasion anomaly and preterm birth. | Diagnostic test | Placenta Previa |
| Magnetic Resonance ImagingPlacenta previa cases will be evaluated at 32nd week by MRI for invasion anomaly and preterm birth. | Diagnostic test | Placenta Previa |
Primary outcome
The number of placental invasion pathologies
Time frame: 1 day
Placental invasion pathologies detected during delivery will be evaluated.
The number of preterm birth
Time frame: 1 day
The relation between preterm birth and placental invasion pathologies will be assessed.
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 23 Mar 2022.
- 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.
Sabahattin a Arı, MD principal investigator
Ege University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vaginal Ultrasonography and Magnetic Resonance Imaging in people with Placenta Previa, run by Ege University at 1 site in Turkey (Türkiye).
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 4 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 23 Mar 2022. 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 Turkey (Türkiye). 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?
The number of placental invasion pathologies (time frame: 1 day). The study lists 2 primary outcomes in all. 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 23 Mar 2022.