Spinal Aesthesia in Women With Placenta Previa Percreta

Complications; Cesarean Section Clinical Trial

— SAW  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02686242
• Other study ID #: XJH-A-2015-6-6-01
• Status: Completed
• Phase: N/A
• First received: January 13, 2016
• Last updated: June 21, 2016
• Start date: December 2015
• Est. completion date: March 2016

Study information

• Verified date: June 2016
• Source: Fourth Military Medical University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Complications; Cesarean Section
• Placenta Previa

Intervention

Procedure:
• spinal anesthesia
bupivacaine injected by spinal puncture
• general anesthesia
general anesthesia with intubation

Locations

Country	Name	City	State
China	Xijing Hospital, Fourth Military Medical University	Xi'an	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
Fourth Military Medical University

Country where clinical trial is conducted

China, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	incidence of hypotension		from beginning of the surgery to the end of the surgery,approximately 1 hour	No
Secondary	usage of norepinephrine		from beginning of the surgery to the end of the surgery,approximately 1 hour	No
Secondary	dose of norepinephrine		from beginning of the surgery to the end of the surgery,approximately 1 hour	No
Secondary	lowest systemic blood pressure		from beginning of the surgery to the end of the surgery,approximately 1 hour	No
Secondary	maximal decrease of systemic blood pressure		from beginning of the surgery to the end of the surgery,approximately 1 hour	No