Fluid Management for Cesarean Section | NCT00488111

Studies
Fluid Management for Cesarean Section

NCT00488111

Sponsor

Nanjing Medical University

Status

Completed

Last Update Posted

Aug 14, 2008Estimated

Enrollment

850Actual

Phase

Not Applicable

Conditions

Cesarean Section

Interventions

Ringer's Lactate
6% Starch

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
NMCH2007-221

Status Module

Record Verification Date

Aug 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2007

Primary Completion Date

Aug 2008Actual

Completion Date

Aug 2008Actual

First Submitted Date

Jun 18, 2007

First Submission Date that Met QC Criteria

Jun 18, 2007

First Posted Date

Jun 19, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 12, 2008

Last Update Posted Date

Aug 14, 2008Estimated

Name	Class
HRSA/Maternal and Child Health Bureau	FED

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

850Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Ringer's Lactate	Other	Ringer's Lactate was used 15min before operation	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Total volume of colloid Total volume of crystalloid Total fluid volume		6 months

Secondary Outcomes

Measure	Description	Time Frame
Percentage reduction in hematocrit, Days in hospital		6 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
XiaoFeng Shen, MD	Nanjing Medical University	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Nanjing Maternal and Child Care Hospital		Nanjing	Jiangsu	210004	China

Intervention Browse Module

MeSH Terms

ID	Term
D000077325	Ringer's Lactate
D013213	Starch

Ancestor Terms

ID	Term
D000077324	Crystalloid Solutions
D007552	Isotonic Solutions
D012996	Solutions
D004364	Pharmaceutical Preparations

Browse Leaves

Not provided

Browse Branches

Not provided