We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01716091
First Posted: October 29, 2012
Last Update Posted: January 7, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Osman Aşıcıoğlu, Istanbul Bakirkoy Maternity and Children Diseases Hospital
  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 Osman Aşıcıoğlu, Istanbul Bakirkoy Maternity and Children Diseases Hospital:

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


Secondary Outcome Measures:
  • postoperative febril morbidity [ Time Frame: postoperative six weeks ]
    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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 44 Years   (Adult)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Submitted: October 22, 2012
First Posted: October 29, 2012
Last Update Posted: January 7, 2015
Last Verified: January 2015

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