Placenta PercretaNCT02702024
The Effectiveness of Double Incision Technique in Uterus Preserving Surgery for Placenta Percreta
A study testing Double uterine incision technique in uterus preserving surgery for placenta percreta in people with Placenta Percreta, run by Kanuni Sultan Suleyman Training and Research Hospital.
Trial summary
Placenta percreta is a life-threatening condition that patients are under risk of massive bleeding. It readily necessitates very complicated surgery even leads to mortality. Cesarean hysterectomy is the procedure that is acknowledged worldwide, however, recent studies discussing conservative treatment with segmental… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Placenta Percreta
- What is being tested?
- Double uterine incision technique in uterus preserving surgery for placenta percreta
- Type of treatment
- Surgery or procedure
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Jan 2014to Jan 2016
- Phase
- Interventional
- 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 18 to 45 years
- Women only
- Adult
Who may be able to join
- Intraoperatively and pathologically confirmed diagnosis of placenta percreta
Who cannot join
- -
About this study
Placenta percreta is a life-threatening condition that patients are under risk of massive bleeding. It readily necessitates very complicated surgery even leads to mortality. Cesarean hysterectomy is the procedure that is acknowledged worldwide, however, recent studies discussing conservative treatment with segmental resections were published. Fetal extraction and segmental resection could be performed from same (single uterine incision) or two different (double uterine incision) incisions. In this study, the investigators aimed to evaluate the effectiveness and the results of double uterine incision.
- Conditions
- Placenta Percreta
- Being tested
- Double uterine incision technique in uterus preserving surgery for placenta percreta
- Keywords
- efficacy, double incision technique, uterus preserving surgery
- Medical subject headings
- Placenta Accreta
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Double uterine incision technique in uterus preserving surgery for placenta percretaProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
The success of segmental resection (Uterus preserving surgery)
No need for hysterectomy due to massive hemorrhage or any other reason in postoperative one month
Measured: Postoperative one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2016 (estimated)
- Study startJan 2014
- Primary completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Placenta PercretaStudies 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
- Interventional
- Phase
- Phase N/A
Sponsor and investigators
- Lead sponsor
- Kanuni Sultan Suleyman Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Burak Yücel, Kanuni Sultan Suleyman Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02702024
- Sponsor's protocol ID
- DIforPP
- Status last verified
- Mar 2016
- First submitted
- 26 Feb 2016
- Last updated
- 8 Mar 2016
- Results posted
- No
- Individual data sharing
- Yes
Publications
Polat I, Yucel B, Gedikbasi A, Aslan H, Fendal A. The effectiveness of double incision technique in uterus preserving surgery for placenta percreta. BMC Pregnancy Childbirth. 2017 Apr 27;17(1):129. doi: 10.1186/s12884-017-1262-3.
PubMed 28449642
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Double Incision Technique in Uterus Preserving Surgery for Placenta Percreta
- ClinicalTrials.gov ID
- NCT02702024
- Acronym / sponsor ID
- DIforPP
- Conditions
- Placenta Percreta
- Keywords
- efficacy, double incision technique, uterus preserving surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Kanuni Sultan Suleyman Training and Research HospitalUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Jan 2016 (actual)
- First posted
- 8 Mar 2016 (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.
Placenta percreta is a life-threatening condition that patients are under risk of massive bleeding. It readily necessitates very complicated surgery even leads to mortality. Cesarean hysterectomy is the procedure that is acknowledged worldwide, however, recent studies discussing conservative treatment with segmental resections were published. Fetal extraction and segmental resection could be performed from same (single uterine incision) or two different (double uterine incision) incisions. In this study, the investigators aimed to evaluate the effectiveness and the results of double uterine incision.
Study design
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Intraoperatively and pathologically confirmed diagnosis of placenta percreta
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 |
|---|---|---|
| Double uterine incision technique in uterus preserving surgery for placenta percreta | Procedure or surgery | – |
Primary outcome
The success of segmental resection (Uterus preserving surgery)
Time frame: Postoperative one month
No need for hysterectomy due to massive hemorrhage or any other reason in postoperative one month
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 8 Mar 2016.
- Derived from this study: PubMed 28449642Polat I, Yucel B, Gedikbasi A, Aslan H, Fendal A. The effectiveness of double incision technique in uterus preserving surgery for placenta percreta. BMC Pregnancy Childbirth. 2017 Apr 27;17(1):129. doi: 10.1186/s12884-017-1262-3.
- Individual participant dataSharing planned: Yes
Related trials for Placenta Percreta
Not yet recruitingObservational study
Prediction of Placenta Accreta Outcome in Pregnant Woman With Placenta Previa Using (hcg_h ) as Abiomarkers
Placenta Accreta / Percreta
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?
A study testing Double uterine incision technique in uterus preserving surgery for placenta percreta in people with Placenta Percreta, run by Kanuni Sultan Suleyman Training and Research 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 8 Mar 2016. 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 success of segmental resection (Uterus preserving surgery) (time frame: Postoperative one month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02702024, which also lists 1 linked publication.
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 8 Mar 2016.