Comparison Between Hysterectomy and Conservative Management in Treatment of Placenta Accreta Regarding Maternal Complication

Completed

• Conditions: Placenta Accreta
• Interventions: Procedure: uterine conservative study; Procedure: hysterectomy

• Registration Number: NCT03327818
• Lead Sponsor: Ain Shams Maternity Hospital

Brief Summary

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.

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 Timeline

• Study Start: 2016-06
• Primary Completion: 2017-01-31
• Study Completion: 2017-01-31
• Status Verified: 2017-10
• Study First Submitted: 2017-10-27
• Study First Submitted QC: 2017-10-27
• Last Update Submitted: 2017-10-27
• Study First Posted: 2017-10-31
• Last Update Posted: 2017-10-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 491

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
conservative surgery group	uterine conservative study	-
hysterectomy group	hysterectomy	-

Primary Outcome Measures

Name	Time	Method
maternal morbidity	24 hours post operative