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NCT00779727 Clinical Trial

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

Pregnancy Clinical Trial

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT00779727
Other study ID # 05/99
Secondary ID
Status Terminated
Phase Phase 4
First received September 4, 2008
Last updated October 23, 2008
Start date October 1999
Est. completion date June 2004

Study information
Verified date September 2008
Source University of Zurich
Contact n/a
Is FDA regulated No
Health authority Switzerland: Ethikkommission
Study type Interventional

Clinical Trial 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

Recruitment information / eligibility
Status Terminated
Enrollment 0
Est. completion date June 2004
Est. primary completion date
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility Inclusion criteria:

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

Exclusion criteria:

- Twin-pregnancies

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Procedure:
• Placement of drainages

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland, 

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