CClinicalTrials.gg
Sign In
CompletedNCT00973414FMCS-IIIUpdated Sep 9, 2009

Fluid Management for Cesarean Section III

An interventional study of Ringer's Lactate and Six percent hydroxyethyl 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 2009-09-09.

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

Regional anesthesia, including epidural, spinal and combined epidural spinal anesthesia (CSEA), is a pivotal part in modern anesthesiology. Previously, the investigators found that epidural and spinal anesthesia during cesarean section possesses different responsiveness to fluid (including crystalloid and colloid) management given prior or posterior to anesthesia. Although CSEA is also widely used as an alternative of single epidural or spinal anesthesia for its combined effect of fast onset of anesthesia of spinal anesthesia and the property of duration of epidural catheterization, the fluid resuscitation during CSEA is still unknown. The investigators hypothesized that fluid management during CSEA would produce different effect on hemodynamics in cesarean section compared with epidural and spinal anesthesia.

02

Conditions studied

  • Cesarean Section

Keywords

  • Combined epidural spinal anesthesia
  • Fluid therapy
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
    Prior crystalloid

    Crystalloid (Ringer's Lactate) was given before CSEA

    Drug: Ringer's Lactate

  • Active comparator
    Posterior crystalloid

    Crystalloid (Ringer's Lactate) was given after CSEA

    Drug: Ringer's Lactate

  • Active comparator
    Prior colloid

    Colloid (6% hydroxyethyl starch) was given before CSEA

    Drug: Six percent hydroxyethyl starch

  • Active comparator
    Posterior colloid

    Colloid (6% hydroxyethyl starch) was given after CSEA

    Drug: Six percent hydroxyethyl starch

Interventions

  • DrugRinger's Lactate

    Ringer's Lactate 8 ml/kg was given intravenously before or after CSEA in cesarean section

    Also known as: Lactated Ringer's solution

  • DrugSix percent hydroxyethyl starch

    Hydroxyethyl starch (6%) was given before or after CSEA in cesarean section

    Also known as: HES/HAES

06

What researchers measure

Primary outcomes

  1. Rate of hypotension

    Time frame: Anesthesia begin (0 min) to 120 min after anesthesia

Secondary outcomes

  1. Recurrence of hypotension after ephedrine or phenylephrine

    Time frame: Anesthesia begin (0 min) to 120 min after anesthesia

  2. Consumption of ephedrine and phenylephrine

    Time frame: Anesthesia begin (0 min) to 120 min after anesthesia

  3. Total volume of colloid or crystalloid

    Time frame: Fifteen minutes before anesthesia to 120 min after anesthesia

  4. One-min and 5-min Apgar scores

    Time frame: The first and fifth minute after cesarean successful delivery

  5. Oxygen saturation during hypotension

    Time frame: Anesthesia begin (0 min) to 120 min after anesthesia

  6. Duration of hypotension

    Time frame: Anesthesia begin (0 min) to 120 min after anesthesia

  7. Low umbilical cord pH (artery < 7.20)

    Time frame: At the time of successful delivery (0 min)

07

Study locations

1 site
  • The Affiliated Nanjing Maternity and Child Health 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 Sep 9, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00973414
Lead sponsor
Nanjing Medical University
First posted
Sep 9, 2009
Start date
Mar 2009
Primary completion
Sep 2009
Completion
Sep 2009
Last update
Sep 9, 2009

Study contacts

XiaoFeng Shen, MD
study chair · Nanjing Medical University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2009. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies from this sponsor

Nanjing Medical University

Start the discussion