NCT00985764

Brief Summary

Effects of placenta previa on incidence and severity of venous air embolism in patients during cesarean delivery

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2007

Typical duration for all trials

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

Study Start

First participant enrolled

May 1, 2007

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2009

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

September 25, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 28, 2009

Completed
Last Updated

November 4, 2010

Status Verified

October 1, 2010

Enrollment Period

2.3 years

First QC Date

September 25, 2009

Last Update Submit

November 3, 2010

Conditions

Cesarean Delivery With Placental Previa

Outcome Measures

Primary Outcomes (1)

  • read sonography records during the surgery

    Three sono views will be recorded rapidly for later interpretation of the stage of air embolism. The midesophageal (ME) 4-chamber view will be continuously monitored during surgery and videotaped. When a bubble is detected in the right atrium (RA), the probe will be turned to the right side and the angle was adjusted to the ME bicaval view to confirm its entrance from the inferior vena cava. Then, the angle will be rapidly re-adjusted to view the ME right ventricle (RV) inflow-outflow view to confirm the extent of air embolism through the right ventricular outflow tract (RVOT).

    After 1 or 2 weeks of surgery

Study Arms (1)

placental previa

Procedure: cesarean delivery

Interventions

cesarean deliveryPROCEDURE
placental previa

Eligibility Criteria

Age20 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

cesarean delivery with placental previa

You may qualify if:

  • Healthy Volunteer with cesarean delivery

You may not qualify if:

  • the one who rejects to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Severance Hospital

Seoul, South Korea

Location

MeSH Terms

Interventions

Cesarean Section

Intervention Hierarchy (Ancestors)

Delivery, ObstetricObstetric Surgical ProceduresSurgical Procedures, Operative

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 25, 2009

First Posted

September 28, 2009

Study Start

May 1, 2007

Primary Completion

September 1, 2009

Study Completion

September 1, 2009

Last Updated

November 4, 2010

Record last verified: 2010-10

Locations

KR(1)