Postoperative Enfectious MorbidityNCT01716091
The Effect of Saline Irrigation in the Peritoneal Cavity at Cesarean Delivery
An observational study of Postoperative Enfectious Morbidity and Postoperative GİS Functionally Recovery, run by Istanbul Bakirkoy Maternity and Children Diseases Hospital at 1 site in Turkey (Türkiye).
Trial summary
The investigators hypotheised that irrigating the abdominal cavity with saline at the time of cesarean delivery will increase Gastrointestinal System Disfunction without maternal infectious morbidity(especially febril morbidity). Read more about this study
- Who is it for?
- Ages 18 to 44 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postoperative Enfectious Morbidity, Postoperative GİS Functionally Recovery
- What is being tested?
- irrigation in the peritoneal cavity
- Type of treatment
- Surgery or procedure
- How many people
- 430 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Nov 2012to Oct 2014
- 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 44 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: all pregnant women between 18 years or older and who requıred cesarean delivery.
Who may be able to join
- Elective cesarean delivery
- Gestational age greater 38 weeks
Who cannot join
- chorioamnıonıtıs
- type 1 diabetes mellitus
- placenta previa and acreata
- prior severe gastrointestional disease
- emergency cesarean delivery
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
T.C. Kanuni Sultan Süleyman Teaching Hospital
Halkalı/İstanbul, Küçükçekmece, 34105
About this study
Official title: The Effect of Saline Irrigation in the Peritoneal Cavity at Cesarean Delivery on Maternal Morbidity and Gastrointestinal System Outcome
The investigators hypotheised that irrigating the abdominal cavity with saline at the time of cesarean delivery will increase Gastrointestinal System Disfunction without maternal infectious morbidity(especially febril morbidity).
- Being tested
- irrigation in the peritoneal cavity
- Keywords
- focus of study is postoperative enfectious morbidity and postoperative GİS functionally recovery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
irrigation in the peritoneal cavityProcedure or surgery
irrigation in the peritoneal cavity after uterine wall closed at cesarean
| Study group | Role | What they receive |
|---|---|---|
| saline irrigation | irrigation group:saline irrigation after uterine wall closed control group:no irrigation after uterine wall closed Receives: Procedure: irrigation in the peritoneal cavity |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative gastrointestinal system disturbance
ıntraoperative and postoperative nausea,emesiz and requirement antıemetic drug
Measured: postoperativeone weeks
Secondary outcomes (1)
postoperative febril morbidity
postoperative endometritis,febril morbidity
Measured: postoperative six weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2012 (estimated)
- Study startNov 2012
- Primary completionAug 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Enfectious MorbidityStudies 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-control
- Time perspective
- Prospective
- Enrolment
- 430 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
- Investigators
- Osman Aşıcıoğlu, M.D., Principal investigator, T.C. Kanuni Sultan Süleyman Teaching Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01716091
- Sponsor's protocol ID
- Aşıcıoğlu 02
- Status last verified
- Jan 2015
- First submitted
- 22 Oct 2012
- Last updated
- 7 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Saline Irrigation in the Peritoneal Cavity at Cesarean Delivery on Maternal Morbidity and Gastrointestinal System Outcome
- ClinicalTrials.gov ID
- NCT01716091
- Acronym / sponsor ID
- Aşıcıoğlu 02
- Keywords
- focus of study is postoperative enfectious morbidity and postoperative GİS functionally recovery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 430 participants (actual)
- Lead sponsor
- Istanbul Bakirkoy Maternity and Children Diseases HospitalOther government
- Study start
- Nov 2012
- Primary completion
- Aug 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 29 Oct 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 investigators hypotheised that irrigating the abdominal cavity with saline at the time of cesarean delivery will increase Gastrointestinal System Disfunction without maternal infectious morbidity(especially febril morbidity).
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| saline irrigation | – | Procedure: irrigation in the peritoneal cavityirrigation group:saline irrigation after uterine wall closed control group:no irrigation after uterine wall closed |
Who may qualify
- Ages
- 18 to 44 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- all pregnant women between 18 years or older and who requıred cesarean delivery.
Key inclusion criteria (2 listed)
- Elective cesarean delivery
- Gestational age greater 38 weeks
Key exclusion criteria (5 listed)
- chorioamnıonıtıs
- type 1 diabetes mellitus
- placenta previa and acreata
- prior severe gastrointestional disease
- emergency cesarean delivery
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 |
|---|---|---|
| irrigation in the peritoneal cavityirrigation in the peritoneal cavity after uterine wall closed at cesarean | Procedure or surgery | saline irrigation |
Primary outcome
postoperative gastrointestinal system disturbance
Time frame: postoperativeone weeks
ıntraoperative and postoperative nausea,emesiz and requirement antıemetic drug
1 secondary outcome
postoperative febril morbidity
Time frame: postoperative six weeks
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 7 Jan 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.
Osman Aşıcıoğlu, M.D. principal investigator
T.C. Kanuni Sultan Süleyman Teaching Hospital
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 Postoperative Enfectious Morbidity and Postoperative GİS Functionally Recovery, 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 2 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 7 Jan 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?
postoperative gastrointestinal system disturbance (time frame: postoperativeone weeks). 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 7 Jan 2015.