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Fluid Management for Cesarean Section (FMCS)

This study has been completed.
Sponsor:
Collaborator:
HRSA/Maternal and Child Health Bureau
Information provided by:
Nanjing Medical University
ClinicalTrials.gov Identifier:
NCT00488111
First received: June 18, 2007
Last updated: August 12, 2008
Last verified: August 2008
History of Changes
  Purpose

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 Intervention
Cesarean Section
 Other: Ringer's Lactate
Other: 6% Starch

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Fluid Management With Ringer's and 6% Starch for Cesarean Section After Epidural or Spinal Anesthesia

Resource links provided by NLM:

MedlinePlus related topics: Cesarean Section
U.S. FDA Resources

Further study details as provided by Nanjing Medical University:

Primary Outcome Measures:
  • Total volume of colloid Total volume of crystalloid Total fluid volume [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Percentage reduction in hematocrit, Days in hospital [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Enrollment: 850
Study Start Date: May 2007
Study Completion Date: August 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   21 Years to 40 Years
Genders 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

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
Study First Received: June 18, 2007
Last Updated: August 12, 2008
Health Authority: China: Ministry of Health

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

Additional relevant MeSH terms:
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
 Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 22, 2013