- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05979181
Peripartum Cesarean Hysterectomy for Placenta Percreta
July 30, 2023 updated by: Mansoura University
Peripartum Cesarean Hysterectomy for Placenta Percreta: a Retrospective Analysis of Cases With and Without Extrauterine Disease
The aim of this study is to address the possible preoperative determinants of extrauterine diseases in cases of placenta previa percreta and to compare the operative and postoperative characteristics of cases with and without extrauterine disease.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This will be a retrospective study of the data of women who underwent cesarean hysterectomy on placenta previa percreta who were classified as Federation of Gynecology and Obstetrics (FIGO) grade 3. Women without extrauterine disease (FIGO grade 3a) will be compared to women with extrauterine disease (FIGO grades 3b and 3c)
Study Type
Observational
Enrollment (Actual)
73
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
-
-
Dakahlia
-
Mansoura, Dakahlia, Egypt, 35111
- Mansoura 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
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Women who underwent cesarean hysterectomy on placenta previa percreta (FIGO grade 3) diagnosed by color flow Doppler, and confirmed intraoperatively
Description
Inclusion Criteria:
- Women who underwent cesarean hysterectomy on placenta previa percreta (FIGO grade 3).
Exclusion Criteria:
- Medical conditions complicating pregnancy.
- Blood diseases or bleeding tendencies
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
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
No extrauterine disease group
Women having placenta previa percreta with no extrauterine disease (FIGO grade 3a)
|
Cesarean hysterectomy due to placenta previa percreta with no extrauterine disease (FIGO grade 3a) or with extrauterine disease (FIGO grades 3b and 3c)
|
|
Extrauterine disease group
Women having placenta previa percreta with extrauterine disease (FIGO grades 3b and 3c)
|
Cesarean hysterectomy due to placenta previa percreta with no extrauterine disease (FIGO grade 3a) or with extrauterine disease (FIGO grades 3b and 3c)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Estimated amount of intraoperative blood loss
Time Frame: From start to end of operation
|
Calculated amount of blood loss during the operation
|
From start to end of operation
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Mohamed S Abdelhafez, MD, Mansoura University
- Study Director: Mahmoud M Awad, MD, Mansoura University
- Principal Investigator: Khaled S Ismail, MD, Mansoura University
- Study Director: Alhussein A Mohamed, MD, Mansoura 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)
October 20, 2018
Primary Completion (Actual)
February 17, 2023
Study Completion (Actual)
February 17, 2023
Study Registration Dates
First Submitted
July 30, 2023
First Submitted That Met QC Criteria
July 30, 2023
First Posted (Actual)
August 7, 2023
Study Record Updates
Last Update Posted (Actual)
August 7, 2023
Last Update Submitted That Met QC Criteria
July 30, 2023
Last Verified
July 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- R.23.06.2211
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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