Fluid Management for Cesarean Section II (FMCS-II)

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)

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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