Complications; Cesarean SectionSAWNCT02686242
Spinal Aesthesia in Women With Placenta Previa Percreta
An observational study of Complications; Cesarean Section, run by Air Force Military Medical University, China at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Complications; Cesarean Section
- What is being tested?
- spinal anesthesia and general anesthesia
- Type of treatment
- Surgery or procedure
- How many people
- 68 participants
- Where
- 1 siteChina
- Study dates
- Dec 2015to Mar 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: parturients with placenta praevia/accreta scheduled for cesarean section
Who may be able to join
- women with placenta previa and increta-percreta (diagnosed by ultrasound and/or magnetic resonance imaging and confirmed during cesarean section)
- women accepted cesarean section
Who cannot join
- women with baseline systemic blood pressure higher than 180 mmHg
- women with coagulation disorder
Trial locations and contacts
1 site in 1 country.
China1 site
Xijing Hospital, Fourth Military Medical University
Xi'an, Shaanxi, 710032
About this study
Official title: 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.
- Conditions
- Complications; Cesarean Section
- Being tested
- spinal anesthesia, general anesthesia
- Keywords
- cesarean section, spinal anesthesia, general anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
spinal anesthesiaProcedure or surgery
bupivacaine injected by spinal puncture
general anesthesiaProcedure or surgery
general anesthesia with intubation
| Study group | Role | What they receive |
|---|---|---|
| spinal anesthesia | patients receive spinal anesthesia before general anesthesia Receives: Procedure: spinal anesthesia | |
| general anesthesia | patients receive general anesthesia Receives: Procedure: general anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of hypotension
Measured: from beginning of the surgery to the end of the surgery,approximately 1 hour
Secondary outcomes (4)
usage of norepinephrine
Measured: from beginning of the surgery to the end of the surgery,approximately 1 hour
dose of norepinephrine
Measured: from beginning of the surgery to the end of the surgery,approximately 1 hour
lowest systemic blood pressure
Measured: from beginning of the surgery to the end of the surgery,approximately 1 hour
maximal decrease of systemic blood pressure
Measured: from beginning of the surgery to the end of the surgery,approximately 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2016 (estimated)
- Study startDec 2015
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Complications; Cesarean SectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Air Force Military Medical University, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhihong LU, Air Force Military Medical University, China
- Investigators
- Hailong Dong, Study chair, Xijing hosptial
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02686242
- Sponsor's protocol ID
- XJH-A-2015-6-6-01
- Acronym
- SAW
- Status last verified
- Jun 2016
- First submitted
- 13 Jan 2016
- Last updated
- 22 Jun 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
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.
PubMed 22568353Ioscovich 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.
PubMed 19665365Mok 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.
PubMed 18513942
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Spinal Anaesthesia on Hemodynamic Stability in Women With Placenta Previa Percreta Undergoing Caesarean Section
- ClinicalTrials.gov ID
- NCT02686242
- Acronym / sponsor ID
- SAW / XJH-A-2015-6-6-01
- Conditions
- Complications; Cesarean Section
- Keywords
- cesarean section, spinal anesthesia, general anesthesia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Air Force Military Medical University, ChinaUniversity, hospital or other
- Study start
- Dec 2015
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 19 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| spinal anesthesia | – | Procedure: spinal anesthesiapatients receive spinal anesthesia before general anesthesia |
| general anesthesia | – | Procedure: general anesthesiapatients receive general anesthesia |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- parturients with placenta praevia/accreta scheduled for cesarean section
Key inclusion criteria (2 listed)
- women with placenta previa and increta-percreta (diagnosed by ultrasound and/or magnetic resonance imaging and confirmed during cesarean section)
- women accepted cesarean section
Key exclusion criteria (2 listed)
- women with baseline systemic blood pressure higher than 180 mmHg
- women with coagulation disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| spinal anesthesiabupivacaine injected by spinal puncture | Procedure or surgery | spinal anesthesia |
| general anesthesiageneral anesthesia with intubation | Procedure or surgery | general anesthesia |
Primary outcome
incidence of hypotension
Time frame: from beginning of the surgery to the end of the surgery,approximately 1 hour
4 secondary outcomes
usage of norepinephrine
Time frame: 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
lowest systemic blood pressure
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2016.
- Background: PubMed 22568353Kocaoglu 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.
- Background: PubMed 19665365Ioscovich 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.
- Background: PubMed 18513942Mok 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hailong Dong study chair
Xijing hosptial
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Complications; Cesarean Section, run by Air Force Military Medical University, China at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
incidence of hypotension (time frame: from beginning of the surgery to the end of the surgery,approximately 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02686242, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2016.