NCT01716091

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
430

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 22, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 29, 2012

Completed
3 days until next milestone

Study Start

First participant enrolled

November 1, 2012

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
Last Updated

January 7, 2015

Status Verified

January 1, 2015

Enrollment Period

1.7 years

First QC Date

October 22, 2012

Last Update Submit

January 6, 2015

Conditions

Postoperative Enfectious MorbidityPostoperative GİS Functionally Recovery

Keywords

focus of study is postoperative enfectious morbidity and postoperative GİS functionally recovery

Outcome Measures

Primary Outcomes (1)

  • postoperative gastrointestinal system disturbance

    ıntraoperative and postoperative nausea,emesiz and requirement antıemetic drug

    postoperativeone weeks

Secondary Outcomes (1)

  • postoperative febril morbidity

    postoperative six weeks

Study Arms (1)

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

irrigation in the peritoneal cavityPROCEDURE

irrigation in the peritoneal cavity after uterine wall closed at cesarean

saline irrigation

Eligibility Criteria

Age18 Years - 44 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • Elective cesarean delivery
  • Gestational age greater 38 weeks

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

T.C. Kanuni Sultan Süleyman Teaching Hospital

Halkalı/İstanbul, Küçükçekmece, 34105, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Therapeutic Irrigation

Intervention Hierarchy (Ancestors)

HydrotherapyPhysical Therapy ModalitiesTherapeuticsRehabilitationInvestigative Techniques

Study Officials

  • Osman Aşıcıoğlu, M.D.

    T.C. Kanuni Sultan Süleyman Teaching Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
T.C. Şişli Etfal E A H

Study Record Dates

First Submitted

October 22, 2012

First Posted

October 29, 2012

Study Start

November 1, 2012

Primary Completion

August 1, 2014

Study Completion

October 1, 2014

Last Updated

January 7, 2015

Record last verified: 2015-01

Locations

TU(1)