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Fluid Management for Cesarean Section (FMCS)

This study has been completed.
HRSA/Maternal and Child Health Bureau
Information provided by:
Nanjing Medical University Identifier:
First received: June 18, 2007
Last updated: August 12, 2008
Last verified: August 2008
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
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:

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 ]

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

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


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

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
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Please refer to this study by its identifier: NCT00488111

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

Responsible Party: XiaoFeng Shen, Nanjing Maternal and Child Health Hospital Identifier: NCT00488111     History of Changes
Other Study ID Numbers: NMU-2579FW
Study First Received: June 18, 2007
Last Updated: August 12, 2008

Keywords provided by Nanjing Medical University:
Regional anesthesia
Fluid Therapy
Hemostasis, Surgical processed this record on June 23, 2017