Spinal Aesthesia in Women With Placenta Previa Percreta (SAW)

June 21, 2016 updated by: Zhihong LU, Air Force Military Medical University, China

Influence of Spinal Anaesthesia on Hemodynamic Stability in Women With Placenta Previa Percreta Undergoing Caesarean Section

Placenta previa percreta is a dangerous complication during surgery. Due to the high risk of hemorrhage, most parturients with placenta previa have to accept cesarean section. In this study investigators compare the effect of different anesthetic techniques on these patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

68

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shaanxi
      • Xi'an, Shaanxi, China, 710032
        • Xijing Hospital, Fourth Military Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

parturients with placenta praevia/accreta scheduled for cesarean section

Description

Inclusion Criteria:

  • women with placenta previa and increta-percreta (diagnosed by ultrasound and/or magnetic resonance imaging and confirmed during cesarean section)
  • women accepted cesarean section

Exclusion Criteria:

  • women with baseline systemic blood pressure higher than 180 mmHg
  • women with coagulation disorder

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
spinal anesthesia
patients receive spinal anesthesia before general anesthesia
Procedure: spinal anesthesia
bupivacaine injected by spinal puncture
general anesthesia
patients receive general anesthesia
Procedure: general anesthesia
general anesthesia with intubation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
incidence of hypotension
Time Frame: from beginning of the surgery to the end of the surgery,approximately 1 hour
from beginning of the surgery to the end of the surgery,approximately 1 hour

Secondary Outcome Measures

Outcome Measure
Time Frame
usage of norepinephrine
Time Frame: from beginning of the surgery to the end of the surgery,approximately 1 hour
from beginning of the surgery to the end of the surgery,approximately 1 hour
dose of norepinephrine
Time Frame: from beginning of the surgery to the end of the surgery,approximately 1 hour
from beginning of the surgery to the end of the surgery,approximately 1 hour
lowest systemic blood pressure
Time Frame: from beginning of the surgery to the end of the surgery,approximately 1 hour
from beginning of the surgery to the end of the surgery,approximately 1 hour
maximal decrease of systemic blood pressure
Time Frame: from beginning of the surgery to the end of the surgery,approximately 1 hour
from beginning of the surgery to the end of the surgery,approximately 1 hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Air Force Military Medical University, China

Investigators

  • Study Chair: Hailong Dong, Xijing Hosptial

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2015

Primary Completion (Actual)

March 1, 2016

Study Completion (Actual)

March 1, 2016

Study Registration Dates

First Submitted

January 13, 2016

First Submitted That Met QC Criteria

February 18, 2016

First Posted (Estimate)

February 19, 2016

Study Record Updates

Last Update Posted (Estimate)

June 22, 2016

Last Update Submitted That Met QC Criteria

June 21, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XJH-A-2015-6-6-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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