Placenta Accreta in Placenta Previa AnteriorNCT02606474
Placenta Accreta&Its Complications in Placenta Previa Cases
An observational study of Placenta Accreta in Placenta Previa Anterior, run by Kasr El Aini Hospital.
Trial summary
Cases of previous cesarean with placenta previa anterior underwent cesarean section. Placenta accreta is diagnosed during cesarean section \&confirmed by pathology. All complications are monitored in cases with placenta accreta and without. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Placenta Accreta in Placenta Previa Anterior
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Nov 2015to Mar 2016
- 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: Pregnant with gestational age more than 30 weeks with previous one or more cesarean section with placenta previa anterior
Who may be able to join
- all pregnant women more than 30 weeks with previous one or more cesarean section with placenta previa anterior
Who cannot join
- pregnant with unscarred uterus
- scars other than cesarean section
About this study
Official title: Incidence of Placenta Accreta & it's Complications in Cases of Previous Cesarean With Placenta Previa Anterior
Cases of previous cesarean with placenta previa anterior underwent cesarean section. Placenta accreta is diagnosed during cesarean section \&confirmed by pathology. All complications are monitored in cases with placenta accreta and without.
Read the detailed description
100 cases of gestational age 30 weeks or more with placenta previa anterior with previous one or more cesarean section will be enrolled. History,examination \&routine investigations will be taken. Colour doppler will be done to diagnose cases with suspected placenta accreta. Pre \& postoperative Hb concentration will be taken. Cases with nonseparation of the placenta will be diagnosed as accreta \& confirmed by pathology. Operative time \& complications like bladder or intestinal injury will be noted. All data will be analyzed.
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with placenta accreta.
Measured: 3 months
Number of patients with bladder injury.
Measured: 3 months
Number of patients with intestinal injury.
Measured: 3 months
Number of patients with cesarean hysterectomy.
Measured: 3 months
Number of deaths.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2015 (estimated)
- Study startNov 2015
- Primary completionMar 2016 (estimated)
- Study completionMar 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Placenta Accreta in Placenta Previa AnteriorStudies 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-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kasr El Aini Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, suzy abdelaziz Abdelhamid, Kasr El Aini Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02606474
- Sponsor's protocol ID
- Obgyn. . .
- Status last verified
- Nov 2015
- First submitted
- 7 Nov 2015
- Last updated
- 17 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence of Placenta Accreta & it's Complications in Cases of Previous Cesarean With Placenta Previa Anterior
- ClinicalTrials.gov ID
- NCT02606474
- Acronym / sponsor ID
- Obgyn. . .
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Kasr El Aini HospitalUniversity, hospital or other
- Study start
- Nov 2015
- Primary completion
- Mar 2016 (estimated)
- Study completion
- Mar 2016 (estimated)
- First posted
- 17 Nov 2015 (estimated)
- 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.
Cases of previous cesarean with placenta previa anterior underwent cesarean section. Placenta accreta is diagnosed during cesarean section \&confirmed by pathology. All complications are monitored in cases with placenta accreta and without.
Detailed description
100 cases of gestational age 30 weeks or more with placenta previa anterior with previous one or more cesarean section will be enrolled. History,examination \&routine investigations will be taken. Colour doppler will be done to diagnose cases with suspected placenta accreta. Pre \& postoperative Hb concentration will be taken. Cases with nonseparation of the placenta will be diagnosed as accreta \& confirmed by pathology. Operative time \& complications like bladder or intestinal injury will be noted. All data will be analyzed.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Pregnant with gestational age more than 30 weeks with previous one or more cesarean section with placenta previa anterior
Key inclusion criteria (1 listed)
- all pregnant women more than 30 weeks with previous one or more cesarean section with placenta previa anterior
Key exclusion criteria (2 listed)
- pregnant with unscarred uterus
- scars other than cesarean section
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of patients with placenta accreta.
Time frame: 3 months
Number of patients with bladder injury.
Time frame: 3 months
Number of patients with intestinal injury.
Time frame: 3 months
Number of patients with cesarean hysterectomy.
Time frame: 3 months
Number of deaths.
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2015.
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 in Placenta Previa Anterior, run by Kasr El Aini 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 2 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: status not confirmed, as of the sponsor's last update on 17 Nov 2015. 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?
Results are not available in the source record.
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?
Number of patients with placenta accreta. (time frame: 3 months). The study lists 5 primary outcomes in all. 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 Nov 2015.