Fluid Management for Cesarean Section II

Not Applicable

Completed

• Conditions: Cesarean Section
• Interventions: Drug: Ringer's Lactate; Drug: Six percent hydroxyethyl starch

• Registration Number: NCT00973791
• Lead Sponsor: Nanjing Medical University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-10
• Primary Completion: 2009-05
• Study Completion: 2009-05
• Status Verified: 2009-09
• Study First Submitted: 2009-09-08
• Study First Submitted QC: 2009-09-08
• Last Update Submitted: 2009-09-08
• Study First Posted: 2009-09-09
• Last Update Posted: 2009-09-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 860

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Prior crystalloid	Ringer's Lactate	Crystalloid (Ringer's Lactate) was given before spinal anesthesia
Posterior crystalloid	Ringer's Lactate	Crystalloid (Ringer's Lactate) was given after spinal anesthesia
Prior colloid	Six percent hydroxyethyl starch	Colloid (6% hydroxyethyl starch) was given before spinal anesthesia
Posterior colloid	Six percent hydroxyethyl starch	Colloid (6% hydroxyethyl starch) was given after spinal anesthesia

Primary Outcome Measures

Name	Time	Method
Rate of hypotension	Anesthesia begin (0 min) to 120 min after anesthesia

Secondary Outcome Measures

Name	Time	Method
Oxygen saturation during hypotension	Anesthesia begin (0 min) to 120 min after anesthesia
Duration of hypotension	Anesthesia begin (0 min) to 120 min after anesthesia
Low umbilical cord pH (artery < 7.20)	At the time of successful delivery (0 min)
Recurrence of hypotension after ephedrine or phenylephrine	Anesthesia begin (0 min) to 120 min after anesthesia
Consumption of ephedrine and phenylephrine	Anesthesia begin (0 min) to 120 min after anesthesia
Total volume of colloid or crystalloid	Fifteen minutes before anesthesia to 120 min after anesthesia
One-min and 5-min Apgar scores	The first and fifth minute after cesarean successful delivery

Trial Locations

Locations (1)

The Affiliated Nanjing Maternity and Child Health Care Hospital; 🇨🇳 Nanjing, Jiangsu, China