Fluid Management for Cesarean Section II

NCT ID: NCT00973791

Last Updated: 2009-09-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

860 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-10-31

Study Completion Date

2009-05-31

Brief Summary

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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

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Conditions

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Cesarean Section

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Prior crystalloid

Crystalloid (Ringer's Lactate) was given before spinal anesthesia

Group Type ACTIVE_COMPARATOR

Ringer's Lactate

Intervention Type DRUG

Ringer's Lactate 8 ml/kg was given intravenously before or after spinal anesthesia in cesarean section

Posterior crystalloid

Crystalloid (Ringer's Lactate) was given after spinal anesthesia

Group Type ACTIVE_COMPARATOR

Ringer's Lactate

Intervention Type DRUG

Ringer's Lactate 8 ml/kg was given intravenously before or after spinal anesthesia in cesarean section

Prior colloid

Colloid (6% hydroxyethyl starch) was given before spinal anesthesia

Group Type ACTIVE_COMPARATOR

Six percent hydroxyethyl starch

Intervention Type DRUG

Hydroxyethyl starch (6%) was given before or after spinal anesthesia in cesarean section

Posterior colloid

Colloid (6% hydroxyethyl starch) was given after spinal anesthesia

Group Type ACTIVE_COMPARATOR

Six percent hydroxyethyl starch

Intervention Type DRUG

Hydroxyethyl starch (6%) was given before or after spinal anesthesia in cesarean section

Interventions

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Ringer's Lactate

Ringer's Lactate 8 ml/kg was given intravenously before or after spinal anesthesia in cesarean section

Intervention Type DRUG

Six percent hydroxyethyl starch

Hydroxyethyl starch (6%) was given before or after spinal anesthesia in cesarean section

Intervention Type DRUG

Other Intervention Names

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Lactated Ringer's solution HES/HAES

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Nanjing Maternity and Child Health Care Hospital

OTHER

Sponsor Role collaborator

Nanjing Medical University

OTHER

Sponsor Role lead

Responsible Party

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Nanjing Medical University

Principal Investigators

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XiaoFeng Shen, MD

Role: STUDY_CHAIR

Nanjing Medical University

Locations

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The Affiliated Nanjing Maternity and Child Health Care Hospital

Nanjing, Jiangsu, China

Site Status

Countries

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China

Other Identifiers

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NJMU-08711MZ

Identifier Type: -

Identifier Source: org_study_id

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