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Fluid Management for Cesarean Section (FMCS)

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ClinicalTrials.gov Identifier: NCT00488111
Recruitment Status : Completed
First Posted : June 19, 2007
Last Update Posted : August 14, 2008
Sponsor:
Collaborator:
HRSA/Maternal and Child Health Bureau
Information provided by:
Nanjing Medical University

Brief Summary:
Cesarean section-associated hypotension is one of the pivotal factors to influence the Apgar Score of children and related with the stable hemostasis during the whole process of labor. How to keep circulation in a consistent stability is yet to be known. The investigators hypothesized that different fluids, crystalloids or colloids, can produced varying effects in keeping the physiological environment of labor from significant fluctuating.

Condition or disease Intervention/treatment Phase
Cesarean Section Other: Ringer's Lactate Other: 6% Starch Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 850 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Fluid Management With Ringer's and 6% Starch for Cesarean Section After Epidural or Spinal Anesthesia
Study Start Date : May 2007
Actual Primary Completion Date : August 2008
Actual Study Completion Date : August 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cesarean Section

Arm Intervention/treatment
Active Comparator: 1
Participants were treated with normal Ringer's solution 15 min before the operation.
Other: Ringer's Lactate
Ringer's Lactate was used 15min before operation
Other Name: RL

Active Comparator: 2
6% Starch was used 15min before operation followed epidural anesthesia.
Other: 6% Starch
6% Starch was used 15min before operation
Other Name: ST




Primary Outcome Measures :
  1. Total volume of colloid Total volume of crystalloid Total fluid volume [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Percentage reduction in hematocrit, Days in hospital [ Time Frame: 6 months ]


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Ages Eligible for Study:   21 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00488111


Locations
China, Jiangsu
Nanjing Maternal and Child Care Hospital
Nanjing, Jiangsu, China, 210004
Sponsors and Collaborators
Nanjing Medical University
HRSA/Maternal and Child Health Bureau
Investigators
Study Chair: XiaoFeng Shen, MD Nanjing Medical University

Responsible Party: XiaoFeng Shen, Nanjing Maternal and Child Health Hospital
ClinicalTrials.gov Identifier: NCT00488111     History of Changes
Other Study ID Numbers: NMU-2579FW
NMCH2007-221
First Posted: June 19, 2007    Key Record Dates
Last Update Posted: August 14, 2008
Last Verified: August 2008

Keywords provided by Nanjing Medical University:
Regional anesthesia
Fluid Therapy
Hemostasis, Surgical