NCT00488111

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
850

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2007

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2007

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 18, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 19, 2007

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2008

Completed
Last Updated

August 14, 2008

Status Verified

August 1, 2008

Enrollment Period

1.3 years

First QC Date

June 18, 2007

Last Update Submit

August 12, 2008

Conditions

Cesarean Section

Keywords

Regional anesthesiaFluid TherapyHemostasis, Surgical

Outcome Measures

Primary Outcomes (1)

  • Total volume of colloid Total volume of crystalloid Total fluid volume

    6 months

Secondary Outcomes (1)

  • Percentage reduction in hematocrit, Days in hospital

    6 months

Study Arms (2)

1

ACTIVE COMPARATOR

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

Other: Ringer's Lactate

2

ACTIVE COMPARATOR

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

Other: 6% Starch

Interventions

Ringer's LactateOTHER

Ringer's Lactate was used 15min before operation

Also known as: RL
1
6% StarchOTHER

6% Starch was used 15min before operation

Also known as: ST
2

Eligibility Criteria

Age21 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • First time of delivery
  • ASA status I-II
  • No premature
  • No genetic and infectious diseases
  • Chinese

You may not qualify if:

  • \< 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nanjing Maternal and Child Care Hospital

Nanjing, Jiangsu, 210004, China

Location

MeSH Terms

Interventions

Ringer's LactateStarch

Intervention Hierarchy (Ancestors)

Crystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical PreparationsGlucansBiopolymersPolymersMacromolecular SubstancesDietary CarbohydratesCarbohydratesPolysaccharides

Study Officials

  • XiaoFeng Shen, MD

    Nanjing Medical University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 18, 2007

First Posted

June 19, 2007

Study Start

May 1, 2007

Primary Completion

August 1, 2008

Study Completion

August 1, 2008

Last Updated

August 14, 2008

Record last verified: 2008-08

Locations

CN(1)