Disruption of Uterine Incision After Cesarean SectionNCT01519440
Randomized Comparison of Sharp Versus Blunt Techniques at Cesarean
An observational study of Disruption of Uterine Incision After Cesarean Section, run by Istanbul Bakirkoy Maternity and Children Diseases Hospital at 1 site in Turkey (Türkiye).
Trial summary
The purpose of this study is to determine whether a specific surgical technique, blunt compared with sharp expansion of the transverse lower uterine incision, is associated with risk of unintended extension of uterine incision Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Disruption of Uterine Incision After Cesarean Section
- How many people
- 1,076 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Mar 2011to Feb 2012
- 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 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: elective cesarean delivery cases
Who may be able to join
- Term pregnancy(> 38 weeks of gestation)
- Required elective cesarean delivery
- maternal age between 18-40 years
Who cannot join
- Required emergency cesarean delivery
- Abnormal presentation
- Planned cesarean hysterectomy
- History of low segment vertical uterine incision
- History of classical upper segment uterine incision
- multiple pregnancy
- cases with a high risk for bleeding(HELLP send, preeclampsia, placental insertion anomalies)
- Grand multiparity(parity>5)
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
İstanbul Bakırköy Maternal and Childrens Hospital
Istanbul, Bakırköy, 34274
About this study
Official title: Unintended Extension of the Lower Segment Uterine Incision at Cesarean Delivery;A Randomized Comparison of Sharp Versus Blunt Techniques
The purpose of this study is to determine whether a specific surgical technique, blunt compared with sharp expansion of the transverse lower uterine incision, is associated with risk of unintended extension of uterine incision
- Keywords
- unintended extension, blunt, sharp, maternal blood loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| blunt | Blunt expansion of the primary incision was derived by placing the index fingers of the operating surgeon into the incision and pulling the fingers apart laterally and cephalad. | |
| sharp | Sharp expansion of the primary incision was developed by cutting laterally and cephalad using bandage scissors |
What is being measured
The primary outcome is the main question the study is designed to answer.
unintended extension of uterine incision
Measured: during the operation
Secondary outcomes (1)
intraoperative maternal blood loss
Measured: after 48 hours than operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2012 (estimated)
- Study startMar 2011
- Primary completionJan 2012
- Study completionFeb 2012
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 Disruption of Uterine Incision After Cesarean SectionStudies 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 crossover
- Time perspective
- Prospective
- Enrolment
- 1,076 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Bakirkoy Maternity and Children Diseases Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Osman Aşıcıoğlu, Istanbul Bakirkoy Maternity and Children Diseases Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01519440
- Sponsor's protocol ID
- Aşıcıoğlu-01
- Status last verified
- Oct 2012
- First submitted
- 24 Jan 2012
- Last updated
- 23 Oct 2012
- Results posted
- No
Publications
Magann EF, Chauhan SP, Bufkin L, Field K, Roberts WE, Martin JN Jr. Intra-operative haemorrhage by blunt versus sharp expansion of the uterine incision at caesarean delivery: a randomised clinical trial. BJOG. 2002 Apr;109(4):448-52. doi: 10.1111/j.1471-0528.2002.01296.x.
PubMed 12013167
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Unintended Extension of the Lower Segment Uterine Incision at Cesarean Delivery;A Randomized Comparison of Sharp Versus Blunt Techniques
- ClinicalTrials.gov ID
- NCT01519440
- Acronym / sponsor ID
- Aşıcıoğlu-01
- Keywords
- unintended extension, blunt, sharp, maternal blood loss
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,076 participants (actual)
- Lead sponsor
- Istanbul Bakirkoy Maternity and Children Diseases HospitalOther government
- Study start
- Mar 2011
- Primary completion
- Jan 2012 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 27 Jan 2012 (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.
The purpose of this study is to determine whether a specific surgical technique, blunt compared with sharp expansion of the transverse lower uterine incision, is associated with risk of unintended extension of uterine incision
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| blunt | – | –Blunt expansion of the primary incision was derived by placing the index fingers of the operating surgeon into the incision and pulling the fingers apart laterally and cephalad. |
| sharp | – | –Sharp expansion of the primary incision was developed by cutting laterally and cephalad using bandage scissors |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- elective cesarean delivery cases
Key inclusion criteria (3 listed)
- Term pregnancy(> 38 weeks of gestation)
- Required elective cesarean delivery
- maternal age between 18-40 years
Key exclusion criteria (8 listed)
- Required emergency cesarean delivery
- Abnormal presentation
- Planned cesarean hysterectomy
- History of low segment vertical uterine incision
- History of classical upper segment uterine incision
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
unintended extension of uterine incision
Time frame: during the operation
1 secondary outcome
intraoperative maternal blood loss
Time frame: after 48 hours than operation
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 23 Oct 2012.
- Results publication: PubMed 12013167Magann EF, Chauhan SP, Bufkin L, Field K, Roberts WE, Martin JN Jr. Intra-operative haemorrhage by blunt versus sharp expansion of the uterine incision at caesarean delivery: a randomised clinical trial. BJOG. 2002 Apr;109(4):448-52. doi: 10.1111/j.1471-0528.2002.01296.x.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Disruption of Uterine Incision After Cesarean Section, run by Istanbul Bakirkoy Maternity and Children Diseases Hospital at 1 site in Turkey (Türkiye).
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 3 inclusion and 8 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 23 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
unintended extension of uterine incision (time frame: during the operation). 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 NCT01519440, 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 23 Oct 2012.