Fluid Management for Cesarean Section

NCT ID: NCT00488111

Last Updated: 2008-08-14

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

850 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-05-31

Study Completion Date

2008-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Cesarean Section

Keywords

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Regional anesthesia Fluid Therapy Hemostasis, Surgical

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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1

Participants were treated with normal Ringer's solution 15 min before the operation.

Group Type ACTIVE_COMPARATOR

Ringer's Lactate

Intervention Type OTHER

Ringer's Lactate was used 15min before operation

2

6% Starch was used 15min before operation followed epidural anesthesia.

Group Type ACTIVE_COMPARATOR

6% Starch

Intervention Type OTHER

6% Starch was used 15min before operation

Interventions

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Ringer's Lactate

Ringer's Lactate was used 15min before operation

Intervention Type OTHER

6% Starch

6% Starch was used 15min before operation

Intervention Type OTHER

Other Intervention Names

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RL ST

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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HRSA/Maternal and Child Health Bureau

FED

Sponsor Role collaborator

Nanjing Medical University

OTHER

Sponsor Role lead

Responsible Party

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Nanjing Maternal and Child Health Hospital

Principal Investigators

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XiaoFeng Shen, MD

Role: STUDY_CHAIR

Nanjing Medical University

Locations

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Nanjing Maternal and Child Care Hospital

Nanjing, Jiangsu, China

Site Status

Countries

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China

Other Identifiers

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NMCH2007-221

Identifier Type: -

Identifier Source: secondary_id

NMU-2579FW

Identifier Type: -

Identifier Source: org_study_id