Placenta AccretaNCT03327818
Comparison Between Hysterectomy and Conservative Management in Treatment of Placenta Accreta Regarding Maternal Complication
An observational study of Placenta Accreta, run by Ain Shams Maternity Hospital.
Trial 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… Read more about this study
- Who is it for?
- Ages 14 to 55 years, women only
- Conditions the study is for
- Placenta Accreta
- What is being tested?
- hysterectomy and uterine conservative study
- Type of treatment
- Surgery or procedure
- How many people
- 491 participants
- Where
- No sites listed yet
- Study dates
- Jun 2016to 31 Jan 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 55 years
- Women only
- Child, Adult
Study population: all cases of placenta accreta present in Ain shams university maternity hospital from 2011 to 2015 and from July 2016 to January 2017
Who may be able to join
- 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.
Who cannot join
- Pregnant women less than 28weeks of gestation. Women with associated medical co-morbidity eg bleeding tendency eg: DM, PET.
About this study
Official title: 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.
Read the 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
- Conditions
- Placenta Accreta
- Being tested
- hysterectomy, uterine conservative study
- Medical subject headings
- Placenta Accreta
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hysterectomyProcedure or surgery
uterine conservative studyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| conservative surgery group | Not described Receives: Procedure: uterine conservative study | |
| hysterectomy group | Not described Receives: Procedure: hysterectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
maternal morbidity
Measured: 24 hours post operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2017
- Study startJun 2016
- Primary completion31 Jan 2017
- Study completion31 Jan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Placenta AccretaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 491 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams Maternity Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wessam Sayed Mohamed, Ain Shams Maternity Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03327818
- Sponsor's protocol ID
- N01MH90003
- Status last verified
- Oct 2017
- First submitted
- 27 Oct 2017
- Last updated
- 31 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Obstetric Hysterectomy Versus Conservative Surgery for Management of Patients With Morbidly Adherent Placenta as Regard Maternal Morbidity and Mortality
- ClinicalTrials.gov ID
- NCT03327818
- Acronym / sponsor ID
- N01MH90003
- Conditions
- Placenta Accreta
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 491 participants (actual)
- Lead sponsor
- Ain Shams Maternity HospitalUniversity, hospital or other
- Study start
- Jun 2016 (actual)
- Primary completion
- 31 Jan 2017 (actual)
- Study completion
- 31 Jan 2017 (actual)
- First posted
- 31 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| conservative surgery group | – | Procedure: uterine conservative study |
| hysterectomy group | – | Procedure: hysterectomy |
Who may qualify
- Ages
- 14 to 55 years
- Sex
- Female only
- Age groups
- Child, Adult
- Study population
- all cases of placenta accreta present in Ain shams university maternity hospital from 2011 to 2015 and from July 2016 to January 2017
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Pregnant women less than 28weeks of gestation. Women with associated medical co-morbidity eg bleeding tendency eg: DM, PET.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| hysterectomy | Procedure or surgery | hysterectomy group |
| uterine conservative study | Procedure or surgery | conservative surgery group |
Primary outcome
maternal morbidity
Time frame: 24 hours post operative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Placenta Accreta, run by Ain Shams Maternity Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
maternal morbidity (time frame: 24 hours post operative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2017.