Management Of Placenta Previa Cases And Determination Of Hospitalization Criteria

March 21, 2022 updated by: Sabahattin Anıl Arı, Ege University
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

98

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • İzmir, Turkey, 35100
        • Ege University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Placenta Previa
Placenta previa cases will be evaluated at 32nd week by vaginal ultrasonography and MRI.
Diagnostic test: Vaginal Ultrasonography
Placenta previa cases will be evaluated at 32nd week by vaginal ultrasonography for invasion anomaly and preterm birth.
Diagnostic test: Magnetic Resonance Imaging
Placenta previa cases will be evaluated at 32nd week by MRI for invasion anomaly and preterm birth.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The number of placental invasion pathologies
Time Frame: 1 day
Placental invasion pathologies detected during delivery will be evaluated.
1 day
The number of preterm birth
Time Frame: 1 day
The relation between preterm birth and placental invasion pathologies will be assessed.
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ege University

Investigators

  • Principal Investigator: Sabahattin a Arı, MD, Ege University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 13, 2018

Primary Completion (ACTUAL)

February 1, 2020

Study Completion (ACTUAL)

February 1, 2020

Study Registration Dates

First Submitted

November 3, 2018

First Submitted That Met QC Criteria

February 9, 2020

First Posted (ACTUAL)

February 11, 2020

Study Record Updates

Last Update Posted (ACTUAL)

March 23, 2022

Last Update Submitted That Met QC Criteria

March 21, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 18-9.1/27

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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