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

NCT ID: NCT00779727

Last Updated: 2008-10-24

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Study Classification: INTERVENTIONAL
• Study Start Date: 1999-10-31
• Study Completion Date: 2004-06-30

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

Conditions

Pregnancy; Hemorrhage

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Placement of drainages

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of Zurich

OTHER

Sponsor Role: lead

Principal Investigators

01 Studienregister MasterAdmins

Role: STUDY_DIRECTOR

UniversitaetsSpital Zuerich

Locations

Zurich, , Switzerland

Countries

Switzerland

Other Identifiers

05/99

Identifier Type: -

Identifier Source: org_study_id