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CompletedNCT00488111FMCSUpdated Aug 14, 2008

Fluid Management for Cesarean Section

An interventional study of Ringer's Lactate and 6% Starch in Cesarean Section, sponsored by Nanjing Medical University. Completed at 1 site in China. Open to female participants aged 21 Years to 40 Years. Per ClinicalTrials.gov, last updated 2008-08-14.

Sponsored by Nanjing Medical University · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
850
Allocation
Randomized
Ages
21 Years to 40 Years
Sex
Female
01

Study 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.

02

Conditions studied

  • Cesarean Section

Keywords

  • Regional anesthesia
  • Fluid Therapy
  • Hemostasis, Surgical
03

In context

Lead sponsor

Nanjing Medical University is the lead sponsor of 169 studies on the registry; 51 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years to 40 Years
Sexes eligible
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

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
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
850 participants (actual)

Study arms

  • Active comparator
    1

    Participants were treated with normal Ringer's solution 15 min before the operation.

    Other: Ringer's Lactate

  • Active comparator
    2

    6% Starch was used 15min before operation followed epidural anesthesia.

    Other: 6% Starch

Interventions

  • OtherRinger's Lactate

    Ringer's Lactate was used 15min before operation

    Also known as: RL

  • Other6% Starch

    6% Starch was used 15min before operation

    Also known as: ST

06

What researchers measure

Primary outcomes

  1. Total volume of colloid Total volume of crystalloid Total fluid volume

    Time frame: 6 months

Secondary outcomes

  1. Percentage reduction in hematocrit, Days in hospital

    Time frame: 6 months

07

Study locations

1 site
  • Nanjing Maternal and Child Care Hospital
    Nanjing, Jiangsu 210004, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 14, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00488111
Lead sponsor
Nanjing Medical University
Collaborators
HRSA/Maternal and Child Health Bureau
First posted
Jun 19, 2007
Start date
May 2007
Primary completion
Aug 2008
Completion
Aug 2008
Last update
Aug 14, 2008

Study contacts

XiaoFeng Shen, MD
study chair · Nanjing Medical University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2008. You cannot join it, but the record below documents what was studied.

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