NCT00779727

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

Trial Health

57
Monitor

Trial Health Score

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

Timeline
Completed

Started Oct 1999

Longer than P75 for phase_4 pregnancy

Geographic Reach
1 country

1 active site

Status
terminated

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

Study Start

First participant enrolled

October 1, 1999

Completed
4.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2004

Completed
4.3 years until next milestone

First Submitted

Initial submission to the registry

September 4, 2008

Completed
2 months until next milestone

First Posted

Study publicly available on registry

October 24, 2008

Completed
Last Updated

October 24, 2008

Status Verified

September 1, 2008

First QC Date

September 4, 2008

Last Update Submit

October 23, 2008

Conditions

PregnancyHemorrhage

Keywords

womenincreasedrisk

Interventions

Placement of drainagesPROCEDURE

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Twin-pregnancies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Zurich, Switzerland

Location

MeSH Terms

Conditions

Hemorrhage

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • 01 Studienregister MasterAdmins

    UniversitaetsSpital Zuerich

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 4, 2008

First Posted

October 24, 2008

Study Start

October 1, 1999

Study Completion

June 1, 2004

Last Updated

October 24, 2008

Record last verified: 2008-09

Locations

CH(1)