Fluid Management for Cesarean Section

Cesarean Section Clinical Trial

— FMCS  

Official title:

Fluid Management With Ringer's and 6% Starch for Cesarean Section After Epidural or Spinal Anesthesia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00488111
• Other study ID #: NMU-2579FW
• Secondary ID: NMCH2007-221
• Status: Completed
• Phase: N/A
• First received: June 18, 2007
• Last updated: August 12, 2008
• Start date: May 2007
• Est. completion date: August 2008

Study information

• Verified date: August 2008
• Source: Nanjing Medical University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 850
• Est. completion date: August 2008
• Est. primary completion date: August 2008
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years to 40 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Cesarean Section

Intervention

Other:
• Ringer's Lactate
Ringer's Lactate was used 15min before operation
• 6% Starch
6% Starch was used 15min before operation

Locations

Country	Name	City	State
China	Nanjing Maternal and Child Care Hospital	Nanjing	Jiangsu

Sponsors (2)

Lead Sponsor	Collaborator
Nanjing Medical University	HRSA/Maternal and Child Health Bureau

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total volume of colloid Total volume of crystalloid Total fluid volume		6 months	Yes
Secondary	Percentage reduction in hematocrit, Days in hospital		6 months	Yes