DeliveryC/SNCT02976311
Comparison of Inflammatory Responses Subsequent to Different Cesarean Section Techniques
A study testing cesarean section(C/S) via the modified Misgav-Ladach technique and cesarean section via the Pfannenstiel-Kerr technique in people with Delivery and Cesarean Delivery, run by Kayseri Education and Research Hospital.
Trial summary
In this study, the investigators aimed to find out whether there are any differences in inflammatory reactions occured subsequent to two different cesarean delivery techniques; modified Misgav-Ladach vs Pfannenstiel-Kerr techniques. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Delivery, Cesarean Delivery, Inflammation
- What is being tested?
- cesarean section(C/S) via the modified Misgav-Ladach technique and cesarean section via the Pfannenstiel-Kerr technique
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- No sites listed yet
- Study dates
- Apr 2016to Sep 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 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Cesarean section for the first time
- Term,singleton pregnancy
Who cannot join
- Any inflammatory disease
- Any pregnancy complication; IUGR,preeclampsia,preterm labor,preterm premature rupture of membranes
- Pregnancies <37weeks gestational age
About this study
Official title: Comparison of Inflammatory Reactions Following Two Different Cesarean Surgery Techniques; The Modified Misgav-Ladach Versus the Pfannenstiel-Kerr Technique
In this study, the investigators aimed to find out whether there are any differences in inflammatory reactions occured subsequent to two different cesarean delivery techniques; modified Misgav-Ladach vs Pfannenstiel-Kerr techniques.
Read the detailed description
Cesarean section is one of the most undertaken operations in women of childbearing age. However, there is not a unique cesarean surgery technique. Pfannenstiel , reported his own technique in 1897. Because of the applicability of the technique, it went down well among obstetricians. After three decades, Kerr evolved this technique, and Pfannenstiel-Kerr technique became the method of choice until late 70's. In 1972, Stark et al defined the Misgav Ladach technique and in the following years this technique became popular among obstetricians. In late 80's Misgav Ladach technique was modified and started to be more popular. But, still Pfannenstiel-Kerr technique continued to be used frequently and studies comparing clinical outcomes of these two techniques were conducted for several times. However, the inflammatory responses which occured subsequent to application of these techniques were not investigated. This is the first study investigating the inflammatory response emerged after different cesarean surgery techniques.
- Conditions
- Delivery, Cesarean Delivery, Inflammation
- Being tested
- cesarean section(C/S) via the modified Misgav-Ladach technique, cesarean section via the Pfannenstiel-Kerr technique
- Keywords
- inflammatory reaction, IL-6, TNF, Misgav Ladach technique, Pfannenstiel-Kerr technique, cesarean delivery, cesarean technique
- Medical subject headings
- Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cesarean section(C/S) via the modified Misgav-Ladach techniqueProcedure or surgery
the first consecutive 44 patients underwent C/S via the modified Misgav-Ladach technique
cesarean section via the Pfannenstiel-Kerr techniqueProcedure or surgery
the second consecutive 44 patients underwent C/S via the Pfannenstiel-Kerr technique
| Study group | Role | What they receive |
|---|---|---|
| Misgav-Ladach | Active comparator | cesarean section(C/S) via the modified 'Misgav-Ladach' technique Receives: Procedure: cesarean section(C/S) via the modified Misgav-Ladach technique |
| Pfannenstiel-Kerr | Active comparator | cesarean section(C/S) via the 'Pfannenstiel-Kerr' technique Receives: Procedure: cesarean section via the Pfannenstiel-Kerr technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
IL-6
percentage of difference in serum IL-6 levels just before the beginning of the surgery and at the 24th hour of the surgery
Measured: 24 hours
TNF-alpha
percentage of difference in serum IL-6 levels just before the beginning of the surgery and at the 24th hour of the surgery
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2016 (estimated)
- Study startApr 2016
- Primary completionAug 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DeliveryStudies 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
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kayseri Education and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Hatice Akkaya, Kayseri Education and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02976311
- Sponsor's protocol ID
- E52332816_51
- Acronym
- C/S
- Status last verified
- Nov 2016
- First submitted
- 22 Nov 2016
- Last updated
- 29 Nov 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: If needed
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Inflammatory Reactions Following Two Different Cesarean Surgery Techniques; The Modified Misgav-Ladach Versus the Pfannenstiel-Kerr Technique
- ClinicalTrials.gov ID
- NCT02976311
- Acronym / sponsor ID
- C/S / E52332816_51
- Conditions
- Delivery, Cesarean Delivery, Inflammation
- Keywords
- inflammatory reaction, IL-6, TNF, Misgav Ladach technique, Pfannenstiel-Kerr technique, cesarean delivery, cesarean technique
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Kayseri Education and Research HospitalOther government
- Study start
- Apr 2016
- Primary completion
- Aug 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 29 Nov 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.
In this study, the investigators aimed to find out whether there are any differences in inflammatory reactions occured subsequent to two different cesarean delivery techniques; modified Misgav-Ladach vs Pfannenstiel-Kerr techniques.
Detailed description
Cesarean section is one of the most undertaken operations in women of childbearing age. However, there is not a unique cesarean surgery technique. Pfannenstiel , reported his own technique in 1897. Because of the applicability of the technique, it went down well among obstetricians. After three decades, Kerr evolved this technique, and Pfannenstiel-Kerr technique became the method of choice until late 70's. In 1972, Stark et al defined the Misgav Ladach technique and in the following years this technique became popular among obstetricians. In late 80's Misgav Ladach technique was modified and started to be more popular. But, still Pfannenstiel-Kerr technique continued to be used frequently and studies comparing clinical outcomes of these two techniques were conducted for several times. However, the inflammatory responses which occured subsequent to application of these techniques were not investigated. This is the first study investigating the inflammatory response emerged after different cesarean surgery techniques.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Misgav-Ladach | Active comparator | Procedure: cesarean section(C/S) via the modified Misgav-Ladach techniquecesarean section(C/S) via the modified 'Misgav-Ladach' technique |
| Pfannenstiel-Kerr | Active comparator | Procedure: cesarean section via the Pfannenstiel-Kerr techniquecesarean section(C/S) via the 'Pfannenstiel-Kerr' technique |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Cesarean section for the first time
- Term,singleton pregnancy
Key exclusion criteria (3 listed)
- Any inflammatory disease
- Any pregnancy complication; IUGR,preeclampsia,preterm labor,preterm premature rupture of membranes
- Pregnancies <37weeks gestational age
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 |
|---|---|---|
| cesarean section(C/S) via the modified Misgav-Ladach techniquethe first consecutive 44 patients underwent C/S via the modified Misgav-Ladach technique | Procedure or surgery | Misgav-Ladach |
| cesarean section via the Pfannenstiel-Kerr techniquethe second consecutive 44 patients underwent C/S via the Pfannenstiel-Kerr technique | Procedure or surgery | Pfannenstiel-Kerr |
Primary outcome
IL-6
Time frame: 24 hours
percentage of difference in serum IL-6 levels just before the beginning of the surgery and at the 24th hour of the surgery
TNF-alpha
Time frame: 24 hours
percentage of difference in serum IL-6 levels just before the beginning of the surgery and at the 24th hour of the 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 29 Nov 2016.
- Individual participant dataSharing planned: Yes. If needed
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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.
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 cesarean section(C/S) via the modified Misgav-Ladach technique and cesarean section via the Pfannenstiel-Kerr technique in people with Delivery and Cesarean Delivery, run by Kayseri Education 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 2 inclusion and 3 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 29 Nov 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?
IL-6 (time frame: 24 hours). The study lists 2 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 29 Nov 2016.