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Post-Cesarean Wound Drainage is Not Necessary in Women at Increased Risk of Hemorrhage

Primary Purpose

Pregnancy, Hemorrhage

Status

Terminated

Phase

Phase 4

Locations

Switzerland

Study Type

Interventional

Intervention

Placement of drainages

About this trial

This is an interventional treatment trial for Pregnancy focused on measuring women, increased, risk

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion criteria:

All pregnant women with increased risk of hemorrhage carrying singleton pregnancies, who had to undergo cesarean section.

Exclusion criteria:

Twin-pregnancies

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT00779727

First Posted

September 4, 2008

Last Updated

October 23, 2008

Sponsor

University of Zurich

1. Study Identification

Unique Protocol Identification Number

NCT00779727

Brief Title

Post-Cesarean Wound Drainage is Not Necessary in Women at Increased Risk of Hemorrhage

Study Type

Interventional

2. Study Status

Record Verification Date

September 2008

Overall Recruitment Status

Terminated

Study Start Date

October 1999 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

June 2004 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

University of Zurich

4. Oversight

5. Study Description

Brief Summary

Randomized controlled trial assessing the benefit of cesarean wound drainage in pregnant women at increased risk of hemorrhage. The pregnant women at increased risk of hemorrhage were randomised in two groups. In one group 2 wound drainages were placed during the cesarean section, in the other group none. Outcome measures were difference between preoperative and postoperative hemoglobin, postoperative fever, cumulative opiate dose adjusted to body weight, length of stay and operation time. It is postulated that the pregnant women with increased risk of hemorrhage do not profit from the routine placement of wound drainages. Trial with surgical intervention

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pregnancy, Hemorrhage

Keywords

women, increased, risk

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

8. Arms, Groups, and Interventions

Intervention Type

Procedure

Intervention Name(s)

Placement of drainages

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion criteria: All pregnant women with increased risk of hemorrhage carrying singleton pregnancies, who had to undergo cesarean section. Exclusion criteria: Twin-pregnancies

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

01 Studienregister MasterAdmins

Organizational Affiliation

UniversitaetsSpital Zuerich

Official's Role

Study Director

Facility Information:

City

Zurich

Country

Switzerland

12. IPD Sharing Statement

Learn more about this trial

Post-Cesarean Wound Drainage is Not Necessary in Women at Increased Risk of Hemorrhage

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