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Cesarean SectionNCT03002636

Safety and Risk Assessment of Obese Parturient Underwent Cesarean Section(CS) Delivery Under Different Anesthesia Ways

A study testing anesthesia in people with Cesarean Section, run by Fudan University.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

900 parturient who underwent CS under general anesthesia(GA) , intraspinal anesthesia included epidural anesthesia(EA) and combined spinal-epidural anesthesia(CSEA), which were divided into 3 groups: Morbid Obesity group (n=300) with body mass index (BMI) >40 kg/m2 , severe Obesity group (n=300) with 30 kg/m2≤BMI ≤40… Read more about this study

Who is it for?
Ages 24 to 35 years, women only
Conditions the study is for
Cesarean Section
What is being tested?
anesthesia
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
900 participants
Where
No sites listed yet
Study dates
Jan 2013to Sep 2016
Phase
Interventional
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 24 to 35 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • patients with ASA Physical Status gradeΙΙ～ΙΙΙ.

Who cannot join

  • scoliosis, congenital heart disease, lung, liver, kidney diseases or increased intracranial pressure (ICP)

About this study

Official title: Safety and Risk Assessment of Obese Parturient Underwent Cesarean Section(CS) Delivery Under General Anesthesia or Intraspinal Anesthesia

900 parturient who underwent CS under general anesthesia(GA) , intraspinal anesthesia included epidural anesthesia(EA) and combined spinal-epidural anesthesia(CSEA), which were divided into 3 groups: Morbid Obesity group (n=300) with body mass index (BMI) >40 kg/m2 , severe Obesity group (n=300) with 30 kg/m2≤BMI ≤40 kg/m2 and non-Obesity group(n=300) with BMI<30 kg/m2. Findings Between January 1, 2013 and September 30, 2016, a total of 1000 women met inclusion criteria and 900 women received allocated intervention. All patients were divided into three groups: Morbid Obesity group(n=300), Severe Obesity group(n=300) and non-Obesity group(n=300) according to body mass index (BMI) >40 kg/m2, 30 kg/m2≤BMI ≤40 kg/m2 and BMI<30 kg/m2.900 patients completed the protocol and related data were analysed.

Read the detailed description

900 parturient who underwent CS under general anesthesia(GA) , intraspinal anesthesia included epidural anesthesia(EA) and combined spinal-epidural anesthesia(CSEA), which were divided into 3 groups

Being tested
anesthesia
Keywords
Obesity, Anesthesia Complications, Body Mass Index (BMI)
Medical subject headings
Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • anesthesiaProcedure or surgery

    Anesthesia : (1) General Anesthesia (GA)(2) Epidural Anesthesia (EA) (3) Combined Spinal-Epidural Anesthesia (CSEA)

Study groups in NCT03002636
Study groupRoleWhat they receive
Morbid Obesity groupExperimentalMorbid Obesity group(n=300)
Receives: Procedure: anesthesia
severe Obesity groupExperimentalsevere Obesity group (n=300)
Receives: Procedure: anesthesia
non-Obesity groupOthernon-Obesity group(n=300)
Receives: Procedure: anesthesia

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Patients numbers of obese parturient complications

    Patients numbers of emergency, fetal macrosomia, gestational diabetes mellitus (GMD), CS history, fetal distress, elderly parturient women(≥35 years), prenatal fever, arrhythmias, abnormalities of the heart, hypertension(pre-eclampsia), multiple pregnancy, precious child, amniotic fluid abnormality, amout of bleeding, neonate Apgar's Score(1min), Apgar's Score(5min), and patients numbers of EA, GA, PACU (Postanesthesia Care Unit ) and ICU (Intensive Care Unit) for duration of hospital stay and anesthesia puncture times with 5>n≥3 and n≥5 in three groups included non-Obesity group, severe Obesity group and Morbid Obesity group were also recorded. In addition, we also recorded puncture patients numbers in sitting position for all groups.

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Dec 2016 (estimated)
  2. Study startJan 2013
  3. Primary completionJan 2016
  4. Study completionSep 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
Single blind
Who is masked
Investigator
Enrolment
900 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03002636
Sponsor's protocol ID
IPMCH-anes
Status last verified
Dec 2016
First submitted
7 Dec 2016
Last updated
26 Dec 2016
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • An X, Zhao Y, Zhang Y, Yang Q, Wang Y, Cheng W, Yang Z. Risk assessment of morbidly obese parturient in cesarean section delivery: A prospective, cohort, single-center study. Medicine (Baltimore). 2017 Oct;96(42):e8265. doi: 10.1097/MD.0000000000008265.

    PubMed 29049219

Questions about this trial

What is this clinical trial studying?

A study testing anesthesia in people with Cesarean Section, run by Fudan University.

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 1 inclusion and 1 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 26 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.

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?

Patients numbers of obese parturient complications (time frame: 2 years). 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 NCT03002636, which also lists 1 linked publication.

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 26 Dec 2016.

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