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

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).

Study Overview

• Status: Completed
• Conditions: Postoperative Enfectious Morbidity; Postoperative GİS Functionally Recovery
• Intervention / Treatment: Procedure: irrigation in the peritoneal cavity

• Study Type: Observational
• Enrollment (Actual): 430

Contacts and Locations

Study Locations

• Turkey
  • Küçükçekmece
    • Halkalı/İstanbul, Küçükçekmece, Turkey, 34105
      • T.C. Kanuni Sultan Süleyman Teaching Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 44 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

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

Description

Inclusion Criteria:

1. Elective cesarean delivery
2. Gestational age greater 38 weeks

Exclusion Criteria:

1. chorioamnıonıtıs
2. type 1 diabetes mellitus
3. placenta previa and acreata
4. prior severe gastrointestional disease
5. emergency cesarean delivery

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
saline irrigation; irrigation group:saline irrigation after uterine wall closed control group:no irrigation after uterine wall closed	Procedure: irrigation in the peritoneal cavity; irrigation in the peritoneal cavity after uterine wall closed at cesarean

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Istanbul Bakirkoy Maternity and Children Diseases Hospital
• Investigators: Principal Investigator: Osman Aşıcıoğlu, M.D., T.C. Kanuni Sultan Süleyman Teaching Hospital

Study record dates

Study Major Dates

• Study Start: November 1, 2012
• Primary Completion (Actual): August 1, 2014
• Study Completion (Actual): October 1, 2014

Study Registration Dates

• First Submitted: October 22, 2012
• First Submitted That Met QC Criteria: October 26, 2012
• First Posted (Estimate): October 29, 2012

Study Record Updates

• Last Update Posted (Estimate): January 7, 2015
• Last Update Submitted That Met QC Criteria: January 6, 2015
• Last Verified: January 1, 2015

More Information

Terms related to this study

• Keywords: focus of study is postoperative enfectious morbidity and postoperative GİS functionally recovery
• Other Study ID Numbers: Aşıcıoğlu 02

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No