Fluid Management for Cesarean Section II

Cesarean Section Clinical Trial

— FMCS-II  

Official title:

Fluid Management for Cesarean Section Undergoing Spinal Anesthesia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00973791
• Other study ID #: NJMU-08711MZ
• Status: Completed
• Phase: N/A
• First received: September 8, 2009
• Last updated: September 8, 2009
• Start date: October 2008
• Est. completion date: May 2009

Study information

• Verified date: September 2009
• Source: Nanjing Medical University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Nanjing Bureau of HealthChina: Nanjing Medical University
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 860
• Est. completion date: May 2009
• Est. primary completion date: May 2009
• 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

Drug:
• Ringer's Lactate
Ringer's Lactate 8 ml/kg was given intravenously before or after spinal anesthesia in cesarean section
• Six percent hydroxyethyl starch
Hydroxyethyl starch (6%) was given before or after spinal anesthesia in cesarean section

Locations

Country	Name	City	State
China	The Affiliated Nanjing Maternity and Child Health Care Hospital	Nanjing	Jiangsu

Sponsors (2)

Lead Sponsor	Collaborator
Nanjing Medical University	Nanjing Maternity and Child Health Care Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of hypotension		Anesthesia begin (0 min) to 120 min after anesthesia	Yes
Secondary	Recurrence of hypotension after ephedrine or phenylephrine		Anesthesia begin (0 min) to 120 min after anesthesia	Yes
Secondary	Consumption of ephedrine and phenylephrine		Anesthesia begin (0 min) to 120 min after anesthesia	Yes
Secondary	Total volume of colloid or crystalloid		Fifteen minutes before anesthesia to 120 min after anesthesia	Yes
Secondary	One-min and 5-min Apgar scores		The first and fifth minute after cesarean successful delivery	Yes
Secondary	Oxygen saturation during hypotension		Anesthesia begin (0 min) to 120 min after anesthesia	Yes
Secondary	Duration of hypotension		Anesthesia begin (0 min) to 120 min after anesthesia	Yes
Secondary	Low umbilical cord pH (artery < 7.20)		At the time of successful delivery (0 min)	Yes