- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03327818
Comparison Between Hysterectomy and Conservative Management in Treatment of Placenta Accreta Regarding Maternal Complication
Obstetric Hysterectomy Versus Conservative Surgery for Management of Patients With Morbidly Adherent Placenta as Regard Maternal Morbidity and Mortality
AIM OF THE WORK The aim of the study is to compare the maternal morbidity and mortality between obstetric hysterectomy and conservative surgery for pregnant ladies > 28 weeks with placenta accreta during caesarean section at Ain Shams University Maternity Hospital in the last five years and prospective study in the next six months.
Hypothesis In women with placenta accrete undergoing hysterectomy may be similar to conservative surgery as regard maternal morbidity and mortality.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The study included all cases of placenta accreta that were diagnosed preoperative or intra-operative and treated by conservative surgery or by hysterectomy during caesarean section between January 2011 to December 2015 at Ain Shams University Maternity Hospital and from July 2016 to January 2017.
The collected data will be categorized according to the way of management and will be analyzed regarding:
Mortality rates.
Intraoperative morbidities:
Blood loss and it's amount and need for transfusion. Amount of blood and blood products transferred. Injury to adjacent organs eg: bladder or bowel injury.
Early postoperative morbidities:
Blood and blood product transfusion Length of maternal Hospital admission post operative Acquiring intensive care unit admission and identifying the cause and duration Wound sepsis Septic shock Peritonitis DVT Acute pulmonary embolism Hysterectomy after conservative management and its indication Wound dehiscence Burst abdomen
Late postoperative morbidities:
Anemia Recurrence of placenta accretes in next pregnancy. Hysterectomy after conservative management and its indication Uterine necrosis Fistula eg. urinary fistula
Study Type
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Women admitted for elective caesarean section. Pregnant women more than 28weeks of gestation. Women with no associated medical diseases eg. DM, PET. Pre-operatively Hemodynamically stable women. Women diagnosed with placenta accrete either preoperative or accidentally discovered intraoperative.
Exclusion Criteria:
- Pregnant women less than 28weeks of gestation. Women with associated medical co-morbidity eg bleeding tendency eg: DM, PET.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
conservative surgery group
|
|
hysterectomy group
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
maternal morbidity
Time Frame: 24 hours post operative
|
24 hours post operative
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- N01 MH90003
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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