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Fluid Management for Cesarean Section (FMCS)

N

Nanjing Medical University

Status

Completed

Conditions

Cesarean Section

Treatments

Other: Ringer's Lactate
Other: 6% Starch

Study type

Interventional

Funder types

Other
Other U.S. Federal agency

Identifiers

NCT00488111
NMU-2579FW
NMCH2007-221

Details and patient eligibility

About

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.

Enrollment

850 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)

850 participants in 2 patient groups

1
Active Comparator group
Description:
Participants were treated with normal Ringer's solution 15 min before the operation.
Treatment:
Other: Ringer's Lactate
2
Active Comparator group
Description:
6% Starch was used 15min before operation followed epidural anesthesia.
Treatment:
Other: 6% Starch

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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