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

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 27, 2014
Last verified: October 2013
  Purpose

we hypotheised that irrigating the abdominal cavity with saline at the time of cesarean delivery will decrease maternal infectious morbidity(especially febril morbidity) without increasing operation time and the rate of GİS disfunction


Condition Intervention
Focus of Study is Postoperative Enfectious Morbidity and Postoperative GİS Functionally Recovery
Procedure: irrigation in the peritoneal cavity with saline.

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective

Resource links provided by NLM:


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

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


Secondary Outcome Measures:
  • postoperative GİS disfunction [ Time Frame: postoperative two days ] [ Designated as safety issue: Yes ]
    postoperative vomiting, nousea and bowel packed


Estimated Enrollment: 460
Study Start Date: November 2012
Study Completion Date: December 2013
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
saline irrigation after uterine wall closed
irrigation group:saline irrigation(500 ml %0.9 NaCl)after uterine wall closed no-irrigation group:no irrigation after uterine wall closed
Procedure: irrigation in the peritoneal cavity with saline.

  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. Between 18 years or older
  2. Requıred ceserean delivery

Exclusion Criteria:

  1. chorioamnıonıtıs
  2. type 1 diabetes mellitus
  3. placenta previa and acreata
  4. prior severe gastrointestional disease
  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 27, 2014
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on October 21, 2014