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Fluid Management for Cesarean Section II (FMCS-II)

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ClinicalTrials.gov Identifier: NCT00973791
Recruitment Status : Completed
First Posted : September 9, 2009
Last Update Posted : September 9, 2009
Sponsor:
Collaborator:
Nanjing Maternity and Child Health Care Hospital
Information provided by:
Nanjing Medical University

Tracking Information
First Submitted Date  ICMJE September 8, 2009
First Posted Date  ICMJE September 9, 2009
Last Update Posted Date September 9, 2009
Study Start Date  ICMJE October 2008
Actual Primary Completion Date May 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 8, 2009)
Rate of hypotension [ Time Frame: Anesthesia begin (0 min) to 120 min after anesthesia ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: September 8, 2009)
  • Recurrence of hypotension after ephedrine or phenylephrine [ Time Frame: Anesthesia begin (0 min) to 120 min after anesthesia ]
  • Consumption of ephedrine and phenylephrine [ Time Frame: Anesthesia begin (0 min) to 120 min after anesthesia ]
  • Total volume of colloid or crystalloid [ Time Frame: Fifteen minutes before anesthesia to 120 min after anesthesia ]
  • One-min and 5-min Apgar scores [ Time Frame: The first and fifth minute after cesarean successful delivery ]
  • Oxygen saturation during hypotension [ Time Frame: Anesthesia begin (0 min) to 120 min after anesthesia ]
  • Duration of hypotension [ Time Frame: Anesthesia begin (0 min) to 120 min after anesthesia ]
  • Low umbilical cord pH (artery < 7.20) [ Time Frame: At the time of successful delivery (0 min) ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Fluid Management for Cesarean Section II
Official Title  ICMJE Fluid Management for Cesarean Section Undergoing Spinal Anesthesia
Brief Summary Fluid management plays an essential role in cesarean section. In previous study (NCT00488111) the investigators found that prior-epidural anesthesia fluid management produced a more significant role in stabilizing the blood pressure and better prognosis after cesarean delivery than that of the posterior-anesthesia ones. Given epidural anesthesia has a time interval before reaching the best state of anesthesia, so the fluid management also has a relatively adequate time to resuscitation. In reality, spinal anesthesia is used popularly except for the epidural anesthesia, whereas spinal anesthesia would produce more significant fluctuation of the hemodynamics compared with the latter. Herein the investigators proposed whether the prior-spinal anesthesia fluid management also produced similar effect on hemodynamic characteristics to the epidural anesthesia.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE Cesarean Section
Intervention  ICMJE
  • Drug: Ringer's Lactate
    Ringer's Lactate 8 ml/kg was given intravenously before or after spinal anesthesia in cesarean section
    Other Name: Lactated Ringer's solution
  • Drug: Six percent hydroxyethyl starch
    Hydroxyethyl starch (6%) was given before or after spinal anesthesia in cesarean section
    Other Name: HES/HAES
Study Arms  ICMJE
  • Active Comparator: Prior crystalloid
    Crystalloid (Ringer's Lactate) was given before spinal anesthesia
    Intervention: Drug: Ringer's Lactate
  • Active Comparator: Posterior crystalloid
    Crystalloid (Ringer's Lactate) was given after spinal anesthesia
    Intervention: Drug: Ringer's Lactate
  • Active Comparator: Prior colloid
    Colloid (6% hydroxyethyl starch) was given before spinal anesthesia
    Intervention: Drug: Six percent hydroxyethyl starch
  • Active Comparator: Posterior colloid
    Colloid (6% hydroxyethyl starch) was given after spinal anesthesia
    Intervention: Drug: Six percent hydroxyethyl starch
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 8, 2009)
860
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 2009
Actual Primary Completion Date May 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 21-40 yr
  • First time of delivery
  • ASA status I-II
  • No premature
  • No genetic and infectious diseases
  • Chinese

Exclusion Criteria:

  • < 21 yr
  • > 40 yr
  • Subjects with cardiac and pulmonary disorders
  • Dislocation of placenta
  • Pregnant hypertension
  • Allergy to local anesthetics
  • Unwilling to cooperation
  • Need intraoperative administration of vascular active agents
  • With significant delivery side effects
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 21 Years to 40 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00973791
Other Study ID Numbers  ICMJE NJMU-08711MZ
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party XiaoFeng Shen, Nanjing Medical University
Study Sponsor  ICMJE Nanjing Medical University
Collaborators  ICMJE Nanjing Maternity and Child Health Care Hospital
Investigators  ICMJE
Study Chair: XiaoFeng Shen, MD Nanjing Medical University
PRS Account Nanjing Medical University
Verification Date September 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP