Management Of Placenta Previa Cases And Determination Of Hospitalization Criteria

NCT04264234 | Completed

• 1 other identifier: 18-9.1/27
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 1

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.

Conditions

Placenta Previa

Keywords

placenta previa; placental invasion anomalies; timing of the birth

Outcome Measures

Primary Outcomes (2)

• The number of placental invasion pathologies

  Placental invasion pathologies detected during delivery will be evaluated.

  1 day

• The number of preterm birth

  The relation between preterm birth and placental invasion pathologies will be assessed.

  1 day

Study Arms (1)

Placenta Previa

EXPERIMENTAL

Placenta previa cases will be evaluated at 32nd week by vaginal ultrasonography and MRI.

Diagnostic Test: Vaginal Ultrasonography; Diagnostic Test: Magnetic Resonance Imaging

Interventions

Vaginal Ultrasonography DIAGNOSTIC_TEST

Placenta previa cases will be evaluated at 32nd week by vaginal ultrasonography for invasion anomaly and preterm birth.

Placenta Previa

Magnetic Resonance Imaging DIAGNOSTIC_TEST

Placenta previa cases will be evaluated at 32nd week by MRI for invasion anomaly and preterm birth.

Placenta Previa

Eligibility Criteria

• Gender Eligibility Details: Pregnant participant
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Multiple pregnancies
• Pregnancy complicated with preeclampsia
• Pregnancy complicated by gestational hypertension
• Pregnancy complicated by gestational diabetes mellitus

Sponsors & Collaborators

• Ege University: lead

Study Sites (1)

Ege University Hospital

Izmir, 35100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Placenta Previa

Interventions

Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Placenta Diseases

Intervention Hierarchy (Ancestors)

Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Sabahattin a Arı, MD

  Ege University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: November 3, 2018
• First Posted: February 11, 2020
• Study Start: November 13, 2018
• Primary Completion: February 1, 2020
• Study Completion: February 1, 2020
• Last Updated: March 23, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)