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Completed

NCT Number: NCT03327818

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

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.

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Key information

Conditions

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

Age range

14 year–55 year

Sex eligibility

Female

Study type

Observational

About this study

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

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Hysterectomy

Procedure

uterine conservative study

Procedure

Primary outcomes

  1. maternal morbidity

    Time frame: 24 hours post operative

Sponsors and collaborators

Lead sponsor

Ain Shams Maternity Hospital

Other

Registry information

Official study title

Obstetric Hysterectomy Versus Conservative Surgery for Management of Patients With Morbidly Adherent Placenta as Regard Maternal Morbidity and Mortality

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Oct 31, 2017
Registry last updated
Oct 31, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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