To Publish Our Experience in the Surgical Management to Placenta Accreta Cases and the Maternal OutcomeNCT03668795
Surgical Management of Placenta Accreta
An observational study of To Publish Our Experience in the Surgical Management to Placenta Accreta Cases and the Maternal Outcome, run by Royal Medical Services, Jordanian Armed Forces.
Trial summary
purpose of this study was to report our experience for surgical management of suspected placenta accreta cases encountered in King Hussein medical center Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- To Publish Our Experience in the Surgical Management to Placenta Accreta Cases and the Maternal Outcome
- What is being tested?
- Bakrey balloon insertion within the uterus and caesarean hysterectomy
- Type of treatment
- Surgery or procedure
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2011to 30 Nov 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: All pregnant ladies who were diagnosed to have placenta previa accreta cases which was diagnosed using ultrasound or MRI
Who may be able to join
- all placenta previa accreta cases encountered in our institution over three year period
Who cannot join
- -
About this study
Official title: Surgical Management of Placenta Accreta a Three Year Experience at King Hussein Medical Center
purpose of this study was to report our experience for surgical management of suspected placenta accreta cases encountered in King Hussein medical center
Read the detailed description
was a retrospective study of all patients who underwent planned deliveries for placenta accreta at King Hussein Medical Centre (KHMC) from August 2011 to October 2014.Demographic characteristics were recorded. Ultrasound (U/S) and magnetic resonance imaging (MRI) were used for the diagnosis. Surgery for all patients were performed by multidisciplinary teams. All information were obtained from patient's files.
- Being tested
- Bakrey balloon insertion within the uterus and caesarean hysterectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bakrey balloon insertion within the uterus and caesarean hysterectomyProcedure or surgery
Also called Interventional radiological insertion of balloon to obstuct the internal iliac artery
Creating an intrauterine tamponade to stop the uterine bleeding by inflating an intrauterine balloon with 600 cc of saline versus undergoing hysterectomy if conservative management failed
What is being measured
The primary outcome is the main question the study is designed to answer.
The intraoperative and short term postoperative complications of surgical interventions in placenta accreta
Intraoperative visceral injuries, bleeding, and short term postoperative morbidity and mortality
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2018
- Study start1 Aug 2011
- Primary completion30 Oct 2014
- Study completion30 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for To Publish Our Experience in the Surgical Management to Placenta Accreta Cases and the Maternal OutcomeStudies 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Royal Medical Services, Jordanian Armed Forces
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mitri Rashed, Royal Medical Services, Jordanian Armed Forces
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03668795
- Sponsor's protocol ID
- RoyalMSJordan
- Status last verified
- Sep 2018
- First submitted
- 11 Sep 2018
- Last updated
- 17 Sep 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surgical Management of Placenta Accreta a Three Year Experience at King Hussein Medical Center
- ClinicalTrials.gov ID
- NCT03668795
- Acronym / sponsor ID
- RoyalMSJordan
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Royal Medical Services, Jordanian Armed ForcesUniversity, hospital or other
- Study start
- 1 Aug 2011 (actual)
- Primary completion
- 30 Oct 2014 (actual)
- Study completion
- 30 Nov 2017 (actual)
- First posted
- 13 Sep 2018 (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.
purpose of this study was to report our experience for surgical management of suspected placenta accreta cases encountered in King Hussein medical center
Detailed description
was a retrospective study of all patients who underwent planned deliveries for placenta accreta at King Hussein Medical Centre (KHMC) from August 2011 to October 2014.Demographic characteristics were recorded. Ultrasound (U/S) and magnetic resonance imaging (MRI) were used for the diagnosis. Surgery for all patients were performed by multidisciplinary teams. All information were obtained from patient's files.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All pregnant ladies who were diagnosed to have placenta previa accreta cases which was diagnosed using ultrasound or MRI
Key inclusion criteria (1 listed)
- all placenta previa accreta cases encountered in our institution over three year period
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Bakrey balloon insertion within the uterus and caesarean hysterectomyAlso: Interventional radiological insertion of balloon to obstuct the internal iliac arteryCreating an intrauterine tamponade to stop the uterine bleeding by inflating an intrauterine balloon with 600 cc of saline versus undergoing hysterectomy if conservative management failed | Procedure or surgery | – |
Primary outcome
The intraoperative and short term postoperative complications of surgical interventions in placenta accreta
Time frame: 48 hours
Intraoperative visceral injuries, bleeding, and short term postoperative morbidity and mortality
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 17 Sep 2018.
- Individual participant dataSharing planned: Undecided
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 To Publish Our Experience in the Surgical Management to Placenta Accreta Cases and the Maternal Outcome, run by Royal Medical Services, Jordanian Armed Forces.
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 17 Sep 2018. 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?
The intraoperative and short term postoperative complications of surgical interventions in placenta accreta (time frame: 48 hours). 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 17 Sep 2018; AzTrials last refreshed its copy on 6 Nov 2026.