Cesarean, ExtraperitonealNCT02155569
Extraperitoneal Versus Transperitoneal Cesarean Section
A study testing Extraperitoneal Cesarean and Transperitoneal Cesarean in people with Cesarean, Extraperitoneal, run by Ataturk University at 1 site in Turkey (Türkiye).
Trial summary
The aim of the study is to compare post operative morbidity between extra peritoneal cesarian and trans peritoneal cesarean section. Read more about this study
- Who is it for?
- Ages 16 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cesarean, Extraperitoneal
- What is being tested?
- Extraperitoneal Cesarean and Transperitoneal Cesarean
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Jan 2014to Dec 2014
- 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 16 to 40 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- elective cesarean (primary or repeated up to four)
Who cannot join
- emergent cesarean
- macrosomia (fetal weight > 4500 g)
- history of major abdominal surgery
- suspected abnormal placentation
- placenta previa
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Extraperitoneal Versus Transperitoneal Cesarean Section: A Prospective Randomized Comparison
The aim of the study is to compare post operative morbidity between extra peritoneal cesarian and trans peritoneal cesarean section.
- Conditions
- Cesarean, Extraperitoneal
- Being tested
- Extraperitoneal Cesarean, Transperitoneal Cesarean
- Keywords
- Cesarean, extraperitoneal, Cesarean, Pain
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extraperitoneal CesareanProcedure or surgery
Pfannenstiel incision, paravesical approach to lower uterine segment extraperitoneally and Kerr incision for uterine entry
Transperitoneal CesareanProcedure or surgery
Pfannenstiel-Kerr technique for laparatomy and uterine entry
| Study group | Role | What they receive |
|---|---|---|
| Transperitoneal Cesarean | Active comparator | Not described Receives: Procedure: Transperitoneal Cesarean |
| Extraperitoneal Cesarean | Active comparator | Not described Receives: Procedure: Extraperitoneal Cesarean |
What is being measured
The primary outcome is the main question the study is designed to answer.
post operative pain
Perceived pain scores will be measured by an visual analog scale.
Measured: One hour before cesarean and 24 hour postoperatively
Secondary outcomes (9)
delivery time
skin incision to delivery
Measured: 2 minutes after delivery
operation time
skin incision to skin closure
Measured: 5 minutes postoperatively
hemoglobin differences
Measured: one hour before cesarean, 48 hour postoperatively
need for extra analgesic
Measured: 48 hour
nausea
Measured: 48 hour
vomiting
Measured: 48 hour
thoracic and shoulder pain
Measured: 48 hour
Urogenital distress measured by Urogenital Distress Inventory
Measured: One hour before cesarean and 24 hour postoperatively
Oral intake
The percentage of patients who tolerates oral intake. Oral intake will be allowed 4-6 hour after cesarean for extraperitoneal group. For intraperitoneal group it will be allowed when patient passed gas.
Measured: 48 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2014 (estimated)
- Study startJan 2014
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cesarean, ExtraperitonealStudies of the same condition, open and under way.
- More trials run by Ataturk UniversityThe sponsor's other registered studies.
- 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ataturk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ragıp Atakan Al, Ataturk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02155569
- Sponsor's protocol ID
- atauni8
- Status last verified
- Jun 2015
- First submitted
- 2 Jun 2014
- Last updated
- 8 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Extraperitoneal Versus Transperitoneal Cesarean Section: A Prospective Randomized Comparison
- ClinicalTrials.gov ID
- NCT02155569
- Acronym / sponsor ID
- atauni8
- Conditions
- Cesarean, Extraperitoneal
- Keywords
- Cesarean, extraperitoneal, Cesarean, Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Ataturk UniversityUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 4 Jun 2014 (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 aim of the study is to compare post operative morbidity between extra peritoneal cesarian and trans peritoneal cesarean section.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transperitoneal Cesarean | Active comparator | Procedure: Transperitoneal Cesarean |
| Extraperitoneal Cesarean | Active comparator | Procedure: Extraperitoneal Cesarean |
Who may qualify
- Ages
- 16 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- elective cesarean (primary or repeated up to four)
Key exclusion criteria (5 listed)
- emergent cesarean
- macrosomia (fetal weight > 4500 g)
- history of major abdominal surgery
- suspected abnormal placentation
- placenta previa
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 |
|---|---|---|
| Extraperitoneal CesareanPfannenstiel incision, paravesical approach to lower uterine segment extraperitoneally and Kerr incision for uterine entry | Procedure or surgery | Extraperitoneal Cesarean |
| Transperitoneal CesareanPfannenstiel-Kerr technique for laparatomy and uterine entry | Procedure or surgery | Transperitoneal Cesarean |
Primary outcome
post operative pain
Time frame: One hour before cesarean and 24 hour postoperatively
Perceived pain scores will be measured by an visual analog scale.
9 secondary outcomes
delivery time
Time frame: 2 minutes after delivery
operation time
Time frame: 5 minutes postoperatively
hemoglobin differences
Time frame: one hour before cesarean, 48 hour postoperatively
need for extra analgesic
Time frame: 48 hour
nausea
Time frame: 48 hour
vomiting
Time frame: 48 hour
thoracic and shoulder pain
Time frame: 48 hour
Urogenital distress measured by Urogenital Distress Inventory
Time frame: One hour before cesarean and 24 hour postoperatively
Oral intake
Time frame: 48 hour
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 Jun 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Extraperitoneal Cesarean and Transperitoneal Cesarean in people with Cesarean, Extraperitoneal, run by Ataturk University 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 1 inclusion and 5 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 Jun 2015. 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?
post operative pain (time frame: One hour before cesarean and 24 hour postoperatively). 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 8 Jun 2015.