Postpartum FeverNCT02760290
Comparison of Extraperitoneal and Intraperitoneal Cesarean Technique
A study testing Extraperitoneal cesarean section and Intraperitoneal cesarean section in people with Postpartum Fever and Ileus, run by Zeynep Kamil Maternity and Pediatric Research and Training Hospital at 1 site in Turkey (Türkiye).
Trial summary
Cesarean section will performed via intraperitoneally and extraperitoneally. During postoperative period pain, need for analgesia, respiratory function tests, ileus, bowel movement, discharged time will be compared. 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
- Postpartum Fever, Ileus, Hemorrhage
- What is being tested?
- Extraperitoneal cesarean section and Intraperitoneal cesarean section
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Mar 2016to Jul 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
- Cesarean section for any reasons
Who cannot join
- Involuntary
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Zeynep Kamil Maternity and Pediatric Research and Training Hospital
Istanbul, 34668
About this study
Official title: Comparison of Extraperitoneal and Intraperitoneal Cesarean Technique: Double Blind Controlled Study
Cesarean section will performed via intraperitoneally and extraperitoneally. During postoperative period pain, need for analgesia, respiratory function tests, ileus, bowel movement, discharged time will be compared.
Read the detailed description
Investigators will compared results intra and extraperitoneal cesarean section. Two groups will determine according to random numbers table. After operations, blood count, C reactive proteins, postoperative temperature, need for analgesia, ileus, bowel movement, mobilization time will compare by blind physician. Abdominal, shoulder and incisional pain at postoperative 0, 6, 12, 18, 24, 30 hours will compared by use visual analog score. Neonatal results and complications also will compare. Investigators and participants will be blind regarding technique.
- Conditions
- Postpartum Fever, Ileus, Hemorrhage, Pain
- Being tested
- Extraperitoneal cesarean section, Intraperitoneal cesarean section
- Keywords
- Forced Expiratory Volume in 1 second, Forced expiratory vital capacity, Peak expiratory flow
- Medical subject headings
- Puerperal Infection, Ileus, Hemorrhage, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extraperitoneal cesarean sectionProcedure or surgery
Intraperitoneal cesarean sectionProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Extraperitoneal group | Experimental | Extraperitoneal cesarean section will perform after rectus sheat incision and carefully bladder dissecting. Receives: Procedure: Extraperitoneal cesarean section |
| Intraperitoneal group | Active comparator | Conventional transperitoneal cesarean will perform Receives: Procedure: Intraperitoneal cesarean section |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Scores as measured by the Visual Analog Scale
Measured: 2 days
Secondary outcomes (7)
Blood count
Measured: 2 days
C reactive proteins level
Measured: 2 days
Complications
Measured: 2 days
Discharge time
Measured: 4 days
Forced expiratory volume in 1 second
Measured: 2 days
Forced vital capacity
Measured: 2 days
Peak expiratory flow
Measured: 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2016 (estimated)
- Study startMar 2016
- Primary completionJul 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Postpartum FeverStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zeynep Kamil Maternity and Pediatric Research and Training Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mehmet Baki Senturk, Zeynep Kamil Maternity and Pediatric Research and Training Hospital
- Investigators
- Mehmet Baki Şentürk, MD, Study director, Zeynep Kamil Maternity and Pediatric Research and Training Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02760290
- Sponsor's protocol ID
- 56
- Status last verified
- Mar 2022
- First submitted
- 14 Mar 2016
- Last updated
- 15 Mar 2022
- Results posted
- No
Publications
Tappauf C, Schest E, Reif P, Lang U, Tamussino K, Schoell W. Extraperitoneal versus transperitoneal cesarean section: a prospective randomized comparison of surgical morbidity. Am J Obstet Gynecol. 2013 Oct;209(4):338.e1-8. doi: 10.1016/j.ajog.2013.05.057. Epub 2013 May 30.
PubMed 23727518Chou CY, Liang PC, Chen CA, Lee CN. Cervical abscess with vaginal fistula after extraperitoneal Cesarean section. J Formos Med Assoc. 2007 Dec;106(12):1048-51. doi: 10.1016/S0929-6646(08)60082-0.
PubMed 18194912
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Extraperitoneal and Intraperitoneal Cesarean Technique: Double Blind Controlled Study
- ClinicalTrials.gov ID
- NCT02760290
- Acronym / sponsor ID
- 56
- Conditions
- Postpartum Fever, Ileus, Hemorrhage, Pain
- Keywords
- Forced Expiratory Volume in 1 second, Forced expiratory vital capacity, Peak expiratory flow
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Zeynep Kamil Maternity and Pediatric Research and Training HospitalUniversity, hospital or other
- Study start
- Mar 2016
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 3 May 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.
Cesarean section will performed via intraperitoneally and extraperitoneally. During postoperative period pain, need for analgesia, respiratory function tests, ileus, bowel movement, discharged time will be compared.
Detailed description
Investigators will compared results intra and extraperitoneal cesarean section. Two groups will determine according to random numbers table. After operations, blood count, C reactive proteins, postoperative temperature, need for analgesia, ileus, bowel movement, mobilization time will compare by blind physician. Abdominal, shoulder and incisional pain at postoperative 0, 6, 12, 18, 24, 30 hours will compared by use visual analog score. Neonatal results and complications also will compare. Investigators and participants will be blind regarding technique.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Extraperitoneal group | Experimental | Procedure: Extraperitoneal cesarean sectionExtraperitoneal cesarean section will perform after rectus sheat incision and carefully bladder dissecting. |
| Intraperitoneal group | Active comparator | Procedure: Intraperitoneal cesarean sectionConventional transperitoneal cesarean will perform |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Cesarean section for any reasons
Key exclusion criteria (1 listed)
- Involuntary
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 cesarean section | Procedure or surgery | Extraperitoneal group |
| Intraperitoneal cesarean section | Procedure or surgery | Intraperitoneal group |
Primary outcome
Pain Scores as measured by the Visual Analog Scale
Time frame: 2 days
7 secondary outcomes
Blood count
Time frame: 2 days
C reactive proteins level
Time frame: 2 days
Complications
Time frame: 2 days
Discharge time
Time frame: 4 days
Forced expiratory volume in 1 second
Time frame: 2 days
Forced vital capacity
Time frame: 2 days
Peak expiratory flow
Time frame: 2 days
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 2022.
- Results publication: PubMed 23727518Tappauf C, Schest E, Reif P, Lang U, Tamussino K, Schoell W. Extraperitoneal versus transperitoneal cesarean section: a prospective randomized comparison of surgical morbidity. Am J Obstet Gynecol. 2013 Oct;209(4):338.e1-8. doi: 10.1016/j.ajog.2013.05.057. Epub 2013 May 30.
- Results publication: PubMed 18194912Chou CY, Liang PC, Chen CA, Lee CN. Cervical abscess with vaginal fistula after extraperitoneal Cesarean section. J Formos Med Assoc. 2007 Dec;106(12):1048-51. doi: 10.1016/S0929-6646(08)60082-0.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
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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.
Mehmet Baki Şentürk, MD study director
Zeynep Kamil Maternity and Pediatric Research and Training Hospital
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 section and Intraperitoneal cesarean section in people with Postpartum Fever and Ileus, run by Zeynep Kamil Maternity and Pediatric Research and Training 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 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 15 Mar 2022. 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?
Pain Scores as measured by the Visual Analog Scale (time frame: 2 days). 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 NCT02760290, which also lists 2 linked publications.
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 2022.