Fluid Management for Cesarean Section (FMCS)

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)

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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