Management Of Placenta Previa Cases And Determination Of Hospitalization Criteria
Primary Purpose
Placenta Previa
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Vaginal Ultrasonography
Magnetic Resonance Imaging
Sponsored by
About this trial
This is an interventional diagnostic trial for Placenta Previa focused on measuring placenta previa, placental invasion anomalies, timing of the birth
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- Multiple pregnancies
- Pregnancy complicated with preeclampsia
- Pregnancy complicated by gestational hypertension
- Pregnancy complicated by gestational diabetes mellitus
Sites / Locations
- Ege University Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Placenta Previa
Arm Description
Placenta previa cases will be evaluated at 32nd week by vaginal ultrasonography and MRI.
Outcomes
Primary Outcome Measures
The number of placental invasion pathologies
Placental invasion pathologies detected during delivery will be evaluated.
The number of preterm birth
The relation between preterm birth and placental invasion pathologies will be assessed.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04264234
Brief Title
Management Of Placenta Previa Cases And Determination Of Hospitalization Criteria
Official Title
Management Of Placenta Previa Cases And Determination Of Hospitalization Criteria
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
November 13, 2018 (Actual)
Primary Completion Date
February 1, 2020 (Actual)
Study Completion Date
February 1, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ege University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Placenta Previa
Keywords
placenta previa, placental invasion anomalies, timing of the birth
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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)
Allocation
N/A
Enrollment
98 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placenta Previa
Arm Type
Experimental
Arm Description
Placenta previa cases will be evaluated at 32nd week by vaginal ultrasonography and MRI.
Intervention Type
Diagnostic Test
Intervention Name(s)
Vaginal Ultrasonography
Intervention Description
Placenta previa cases will be evaluated at 32nd week by vaginal ultrasonography for invasion anomaly and preterm birth.
Intervention Type
Diagnostic Test
Intervention Name(s)
Magnetic Resonance Imaging
Intervention Description
Placenta previa cases will be evaluated at 32nd week by MRI for invasion anomaly and preterm birth.
Primary Outcome Measure Information:
Title
The number of placental invasion pathologies
Description
Placental invasion pathologies detected during delivery will be evaluated.
Time Frame
1 day
Title
The number of preterm birth
Description
The relation between preterm birth and placental invasion pathologies will be assessed.
Time Frame
1 day
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
Pregnant participant
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
Multiple pregnancies
Pregnancy complicated with preeclampsia
Pregnancy complicated by gestational hypertension
Pregnancy complicated by gestational diabetes mellitus
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sabahattin a Arı, MD
Organizational Affiliation
Ege University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ege University Hospital
City
İzmir
ZIP/Postal Code
35100
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
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Management Of Placenta Previa Cases And Determination Of Hospitalization Criteria
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