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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Osman Aşıcıoğlu, Istanbul Bakirkoy Maternity and Children Diseases Hospital
ClinicalTrials.gov Identifier:
NCT01716091
First received: October 22, 2012
Last updated: January 6, 2015
Last verified: January 2015
  Purpose

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).


Condition Intervention
Postoperative Enfectious Morbidity
Postoperative GİS Functionally Recovery
Procedure: irrigation in the peritoneal cavity

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: The Effect of Saline Irrigation in the Peritoneal Cavity at Cesarean Delivery on Maternal Morbidity and Gastrointestinal System Outcome

Resource links provided by NLM:


Further study details as provided by Istanbul Bakirkoy Maternity and Children Diseases Hospital:

Primary Outcome Measures:
  • postoperative gastrointestinal system disturbance [ Time Frame: postoperativeone weeks ] [ Designated as safety issue: Yes ]
    ıntraoperative and postoperative nausea,emesiz and requirement antıemetic drug


Secondary Outcome Measures:
  • postoperative febril morbidity [ Time Frame: postoperative six weeks ] [ Designated as safety issue: Yes ]
    postoperative endometritis,febril morbidity


Enrollment: 430
Study Start Date: November 2012
Study Completion Date: October 2014
Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 44 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

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

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01716091

Locations
Turkey
T.C. Kanuni Sultan Süleyman Teaching Hospital
Halkalı/İstanbul, Küçükçekmece, Turkey, 34105
Sponsors and Collaborators
Istanbul Bakirkoy Maternity and Children Diseases Hospital
Investigators
Principal Investigator: Osman Aşıcıoğlu, M.D. T.C. Kanuni Sultan Süleyman Teaching Hospital
  More Information

No publications provided

Responsible Party: Osman Aşıcıoğlu, T.C. Şişli Etfal E A H, Istanbul Bakirkoy Maternity and Children Diseases Hospital
ClinicalTrials.gov Identifier: NCT01716091     History of Changes
Other Study ID Numbers: Aşıcıoğlu 02
Study First Received: October 22, 2012
Last Updated: January 6, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by Istanbul Bakirkoy Maternity and Children Diseases Hospital:
focus of study is postoperative enfectious morbidity and postoperative GİS functionally recovery

ClinicalTrials.gov processed this record on July 27, 2015