Labor PainNCT02479932
A Comparison of Extraperitoneal Versus Transperitoneal Cesarean Section
A study testing Transperitoneal cesarean technique and Extraperitoneal cesarean technique in people with Labor Pain, run by Ataturk University at 1 site in Turkey (Türkiye).
Trial summary
The aim of study is to compare skin-to-delivery time and postoperative morbidity between extraperitoneal cesarean and transpirational cesarean. 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
- Labor Pain
- What is being tested?
- Transperitoneal cesarean technique and Extraperitoneal cesarean technique
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Jun 2015to 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 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- elective cesarean
- previous cesarean (<4)
- cesarean for distocia
Who cannot join
- emergency cesarean ( fetal distress)
- risk of obstetrical bleeding
- maternal coagulation defects
- adnexial mass
- uterin myoma at incision site
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Atatürk Üniversitesi Araştırma Hastanesi
Erzurum, 25240
About this study
Official title: A Comparison of Skin to Delivery Time at Exztraperitoneal vs. Transpirational Cesarean
The aim of study is to compare skin-to-delivery time and postoperative morbidity between extraperitoneal cesarean and transpirational cesarean.
- Conditions
- Labor Pain
- Being tested
- Transperitoneal cesarean technique, Extraperitoneal cesarean technique
- Keywords
- Extra-peritoneal cesarean, Intra-peritoneal cesarean
- Medical subject headings
- Labor Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transperitoneal cesarean techniqueOther
Pfannenstiel-Kerr technique for laparatomy and uterine entry
Extraperitoneal cesarean techniqueOther
Pfannenstiel incision, paravesical approach to lower uterine segment extraperitoneally and Kerr incision for uterine entry
| Study group | Role | What they receive |
|---|---|---|
| Extraperitoneal cesarean | Active comparator | Not described Receives: Other: Extraperitoneal cesarean technique |
| Transperitoneal cesarean | Active comparator | Not described Receives: Other: Transperitoneal cesarean technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Skin-to-delivery time
Measured: 1 minute after delivery
Secondary outcomes (11)
Postoperative pain
Pain will be measured by VAS
Measured: 24 and 48 hour after cesarean
Operation time
skin-to-skin operation time
Measured: Two minutes after surgery
Hemoglobin differences
Measured: One hour before cesarean and 48 hours after cesarean
Need for analgesic
All analgesic given after cesarean at hospital
Measured: 24 and 48 hours after cesarean
Nausea
Nausea during surgery and after surgery
Measured: Two minutes and 48 hours after cesarean
Vomiting
Nausea during and after surgery
Measured: Two minutes and 48 hours after cesarean
Thoracic shoulder pain
Thoracic shoulder pain after surgery
Measured: 48 hours after cesarean
Urogenital distress measured by Urogenital Distress Inventory
Measured: One hour before cesarean and 24 hours after cesarean
Oral intake
The percentage of patients who tolerates oral intake. Oral intake will be allowed 4-6 hours after cesarean for extraperitoneal group. For intraperitoneal group it will be allowed when patient passed gas.
Measured: 12 and 24 hours postoperatively
Anxiety during surgery
Intense fear or anxiety during surgery without pain (yes or no)
Measured: One minute after cesarean
Pain during surgery
Abdominal pain during surgery (yes or no)
Measured: One minutes after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2015 (estimated)
- Study startJun 2015
- Primary completionJan 2016
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Labor PainStudies 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
- 210 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ataturk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ragıp Atakan Al, Ataturk University
- Investigators
- Yunus E TOPDAGI, MD, Principal investigator, Ataturk UniversityOmer E Yapca, MD, Study director, Ataturk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02479932
- Sponsor's protocol ID
- 77-2015
- Status last verified
- Mar 2016
- First submitted
- 11 Jun 2015
- Last updated
- 15 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Skin to Delivery Time at Exztraperitoneal vs. Transpirational Cesarean
- ClinicalTrials.gov ID
- NCT02479932
- Acronym / sponsor ID
- 77-2015
- Conditions
- Labor Pain
- Keywords
- Extra-peritoneal cesarean, Intra-peritoneal cesarean
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 210 participants (actual)
- Lead sponsor
- Ataturk UniversityUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 24 Jun 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.
The aim of study is to compare skin-to-delivery time and postoperative morbidity between extraperitoneal cesarean and transpirational cesarean.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Extraperitoneal cesarean | Active comparator | Other: Extraperitoneal cesarean technique |
| Transperitoneal cesarean | Active comparator | Other: Transperitoneal cesarean technique |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- elective cesarean
- previous cesarean (<4)
- cesarean for distocia
Key exclusion criteria (5 listed)
- emergency cesarean ( fetal distress)
- risk of obstetrical bleeding
- maternal coagulation defects
- adnexial mass
- uterin myoma at incision site
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 |
|---|---|---|
| Transperitoneal cesarean techniquePfannenstiel-Kerr technique for laparatomy and uterine entry | Other | Transperitoneal cesarean |
| Extraperitoneal cesarean techniquePfannenstiel incision, paravesical approach to lower uterine segment extraperitoneally and Kerr incision for uterine entry | Other | Extraperitoneal cesarean |
Primary outcome
Skin-to-delivery time
Time frame: 1 minute after delivery
11 secondary outcomes
Postoperative pain
Time frame: 24 and 48 hour after cesarean
Operation time
Time frame: Two minutes after surgery
Hemoglobin differences
Time frame: One hour before cesarean and 48 hours after cesarean
Need for analgesic
Time frame: 24 and 48 hours after cesarean
Nausea
Time frame: Two minutes and 48 hours after cesarean
Vomiting
Time frame: Two minutes and 48 hours after cesarean
Thoracic shoulder pain
Time frame: 48 hours after cesarean
Urogenital distress measured by Urogenital Distress Inventory
Time frame: One hour before cesarean and 24 hours after cesarean
Oral intake
Time frame: 12 and 24 hours postoperatively
Anxiety during surgery
Time frame: One minute after cesarean
Pain during surgery
Time frame: One minutes after surgery
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 15 Mar 2016.
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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.
Yunus E TOPDAGI, MD principal investigator
Ataturk University
Omer E Yapca, MD study director
Ataturk University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transperitoneal cesarean technique and Extraperitoneal cesarean technique in people with Labor Pain, 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 3 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 15 Mar 2016. 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?
Skin-to-delivery time (time frame: 1 minute after delivery). 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 15 Mar 2016.