NCT02686242

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
68

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2015

Shorter than P25 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2015

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 13, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 19, 2016

Completed
11 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

June 22, 2016

Status Verified

June 1, 2016

Enrollment Period

3 months

First QC Date

January 13, 2016

Last Update Submit

June 21, 2016

Conditions

Keywords

cesarean sectionspinal anesthesiageneral anesthesia

Outcome Measures

Primary Outcomes (1)

  • incidence of hypotension

    from beginning of the surgery to the end of the surgery,approximately 1 hour

Secondary Outcomes (4)

  • usage of norepinephrine

    from beginning of the surgery to the end of the surgery,approximately 1 hour

  • dose of norepinephrine

    from beginning of the surgery to the end of the surgery,approximately 1 hour

  • lowest systemic blood pressure

    from beginning of the surgery to the end of the surgery,approximately 1 hour

  • maximal decrease of systemic blood pressure

    from beginning of the surgery to the end of the surgery,approximately 1 hour

Study Arms (2)

spinal anesthesia

patients receive spinal anesthesia before general anesthesia

Procedure: spinal anesthesia

general anesthesia

patients receive general anesthesia

Procedure: general anesthesia

Interventions

bupivacaine injected by spinal puncture

spinal anesthesia

general anesthesia with intubation

general anesthesia

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

parturients with placenta praevia/accreta scheduled for cesarean section

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Xijing Hospital, Fourth Military Medical University

Xi'an, Shaanxi, 710032, China

Location

Related Publications (3)

  • Kocaoglu N, Gunusen I, Karaman S, Ergenoglu AM, Firat V. Management of anesthesia for cesarean section in parturients with placenta previa with/without placenta accreta: a retrospective study. Ginekol Pol. 2012 Feb;83(2):99-103.

    PMID: 22568353BACKGROUND
  • Ioscovich A, Mirochnitchenko E, Halpern S, Samueloff A, Grisaru-Granovsky S, Gozal Y, Einav S. Perioperative anaesthetic management of high-order repeat caesarean section: audit of practice in a university-affiliated medical centre. Int J Obstet Anesth. 2009 Oct;18(4):314-9. doi: 10.1016/j.ijoa.2009.01.014. Epub 2009 Aug 7.

    PMID: 19665365BACKGROUND
  • Mok M, Heidemann B, Dundas K, Gillespie I, Clark V. Interventional radiology in women with suspected placenta accreta undergoing caesarean section. Int J Obstet Anesth. 2008 Jul;17(3):255-61. doi: 10.1016/j.ijoa.2007.11.010. Epub 2008 Jun 2.

    PMID: 18513942BACKGROUND

MeSH Terms

Interventions

Anesthesia, SpinalAnesthesia, General

Intervention Hierarchy (Ancestors)

Anesthesia, ConductionAnesthesiaAnesthesia and Analgesia

Study Officials

  • Hailong Dong

    Xijing hosptial

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

January 13, 2016

First Posted

February 19, 2016

Study Start

December 1, 2015

Primary Completion

March 1, 2016

Study Completion

March 1, 2016

Last Updated

June 22, 2016

Record last verified: 2016-06

Locations