The Effect of Saline Irrigation in the Peritoneal Cavity... | NCT01716091

Studies
The Effect of Saline Irrigation in the Peritoneal Cavity at Cesarean Delivery

NCT01716091

Sponsor

Istanbul Bakirkoy Maternity and Children Diseases Hospital

Status

Completed

Last Update Posted

Jan 7, 2015Estimated

Enrollment

430Actual

Phase

Not provided

Conditions

Postoperative Enfectious Morbidity
Postoperative GİS Functionally Recovery

Interventions

irrigation in the peritoneal cavity

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2012

Primary Completion Date

Aug 2014Actual

Completion Date

Oct 2014Actual

First Submitted Date

Oct 22, 2012

First Submission Date that Met QC Criteria

Oct 26, 2012

First Posted Date

Oct 29, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 6, 2015

Last Update Posted Date

Jan 7, 2015Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Osman Aşıcıoğlu, T.C. Şişli Etfal E A H, Istanbul Bakirkoy Maternity and Children Diseases HospitalPrincipal Investigator

Lead Sponsor

Istanbul Bakirkoy Maternity and Children Diseases HospitalOTHER_GOV

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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).

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

430Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
saline irrigation		irrigation group:saline irrigation after uterine wall closed control group:no irrigation after uterine wall closed	Procedure: irrigation in the peritoneal cavity

Interventions

Name	Type	Description	Arm Group Labels	Other Names
irrigation in the peritoneal cavity	Procedure	irrigation in the peritoneal cavity after uterine wall closed at cesarean	saline irrigation

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
postoperative gastrointestinal system disturbance	ıntraoperative and postoperative nausea,emesiz and requirement antıemetic drug	postoperativeone weeks

Secondary Outcomes

Measure	Description	Time Frame
postoperative febril morbidity	postoperative endometritis,febril morbidity	postoperative six weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Elective cesarean delivery
Gestational age greater 38 weeks

Exclusion Criteria:

chorioamnıonıtıs
type 1 diabetes mellitus
placenta previa and acreata
prior severe gastrointestional disease
emergency cesarean delivery

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

44 Years

Standard Ages

Adult

Study Population

all pregnant women between 18 years or older and who requıred cesarean delivery.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Osman Aşıcıoğlu, M.D.	T.C. Kanuni Sultan Süleyman Teaching Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
T.C. Kanuni Sultan Süleyman Teaching Hospital		Halkalı/İstanbul	Küçükçekmece	34105	Turkey (Türkiye)

Intervention Browse Module

MeSH Terms

ID	Term
D007507	Therapeutic Irrigation

Ancestor Terms

ID	Term
D006875	Hydrotherapy
D026741	Physical Therapy Modalities
D013812	Therapeutics
D012046	Rehabilitation

Browse Leaves

Not provided

Browse Branches

Not provided