Fluid Management for Cesarean Section II (FMCS-II)

N

Nanjing Medical University

Status

Completed

Conditions

Cesarean Section

Treatments

Drug: Ringer's Lactate
Drug: Six percent hydroxyethyl starch

Study type

Interventional

Funder types

Other

Identifiers

NCT00973791
NJMU-08711MZ

Details and patient eligibility

About

Fluid management plays an essential role in cesarean section. In previous study (NCT00488111) the investigators found that prior-epidural anesthesia fluid management produced a more significant role in stabilizing the blood pressure and better prognosis after cesarean delivery than that of the posterior-anesthesia ones. Given epidural anesthesia has a time interval before reaching the best state of anesthesia, so the fluid management also has a relatively adequate time to resuscitation. In reality, spinal anesthesia is used popularly except for the epidural anesthesia, whereas spinal anesthesia would produce more significant fluctuation of the hemodynamics compared with the latter. Herein the investigators proposed whether the prior-spinal anesthesia fluid management also produced similar effect on hemodynamic characteristics to the epidural anesthesia.

Enrollment

860 patients

Sex

Female

Ages

21 to 40 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

860 participants in 4 patient groups

Prior crystalloid
Active Comparator group
Description:
Crystalloid (Ringer's Lactate) was given before spinal anesthesia
Treatment:
Drug: Ringer's Lactate
Posterior crystalloid
Active Comparator group
Description:
Crystalloid (Ringer's Lactate) was given after spinal anesthesia
Treatment:
Drug: Ringer's Lactate
Prior colloid
Active Comparator group
Description:
Colloid (6% hydroxyethyl starch) was given before spinal anesthesia
Treatment:
Drug: Six percent hydroxyethyl starch
Posterior colloid
Active Comparator group
Description:
Colloid (6% hydroxyethyl starch) was given after spinal anesthesia
Treatment:
Drug: Six percent hydroxyethyl starch

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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