Fluid Management for Cesarean Section II (FMCS-II)

This study has been completed.
Sponsor:
Collaborator:
Nanjing Maternity and Child Health Care Hospital
Information provided by:
Nanjing Medical University
ClinicalTrials.gov Identifier:
NCT00973791
First received: September 8, 2009
Last updated: NA
Last verified: September 2009
History: No changes posted
  Purpose

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.


Condition Intervention
Cesarean Section
Drug: Ringer's Lactate
Drug: Six percent hydroxyethyl starch

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Fluid Management for Cesarean Section Undergoing Spinal Anesthesia

Resource links provided by NLM:


Further study details as provided by Nanjing Medical University:

Primary Outcome Measures:
  • Rate of hypotension [ Time Frame: Anesthesia begin (0 min) to 120 min after anesthesia ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Recurrence of hypotension after ephedrine or phenylephrine [ Time Frame: Anesthesia begin (0 min) to 120 min after anesthesia ] [ Designated as safety issue: Yes ]
  • Consumption of ephedrine and phenylephrine [ Time Frame: Anesthesia begin (0 min) to 120 min after anesthesia ] [ Designated as safety issue: Yes ]
  • Total volume of colloid or crystalloid [ Time Frame: Fifteen minutes before anesthesia to 120 min after anesthesia ] [ Designated as safety issue: Yes ]
  • One-min and 5-min Apgar scores [ Time Frame: The first and fifth minute after cesarean successful delivery ] [ Designated as safety issue: Yes ]
  • Oxygen saturation during hypotension [ Time Frame: Anesthesia begin (0 min) to 120 min after anesthesia ] [ Designated as safety issue: Yes ]
  • Duration of hypotension [ Time Frame: Anesthesia begin (0 min) to 120 min after anesthesia ] [ Designated as safety issue: Yes ]
  • Low umbilical cord pH (artery < 7.20) [ Time Frame: At the time of successful delivery (0 min) ] [ Designated as safety issue: Yes ]

Enrollment: 860
Study Start Date: October 2008
Study Completion Date: May 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Prior crystalloid
Crystalloid (Ringer's Lactate) was given before spinal anesthesia
Drug: Ringer's Lactate
Ringer's Lactate 8 ml/kg was given intravenously before or after spinal anesthesia in cesarean section
Other Name: Lactated Ringer's solution
Active Comparator: Posterior crystalloid
Crystalloid (Ringer's Lactate) was given after spinal anesthesia
Drug: Ringer's Lactate
Ringer's Lactate 8 ml/kg was given intravenously before or after spinal anesthesia in cesarean section
Other Name: Lactated Ringer's solution
Active Comparator: Prior colloid
Colloid (6% hydroxyethyl starch) was given before spinal anesthesia
Drug: Six percent hydroxyethyl starch
Hydroxyethyl starch (6%) was given before or after spinal anesthesia in cesarean section
Other Name: HES/HAES
Active Comparator: Posterior colloid
Colloid (6% hydroxyethyl starch) was given after spinal anesthesia
Drug: Six percent hydroxyethyl starch
Hydroxyethyl starch (6%) was given before or after spinal anesthesia in cesarean section
Other Name: HES/HAES

  Eligibility

Ages Eligible for Study:   21 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00973791

Locations
China, Jiangsu
The Affiliated Nanjing Maternity and Child Health Care Hospital
Nanjing, Jiangsu, China, 210004
Sponsors and Collaborators
Nanjing Medical University
Nanjing Maternity and Child Health Care Hospital
Investigators
Study Chair: XiaoFeng Shen, MD Nanjing Medical University
  More Information

No publications provided

Responsible Party: XiaoFeng Shen, Nanjing Medical University
ClinicalTrials.gov Identifier: NCT00973791     History of Changes
Other Study ID Numbers: NJMU-08711MZ
Study First Received: September 8, 2009
Last Updated: September 8, 2009
Health Authority: China: Nanjing Bureau of Health
China: Nanjing Medical University

Keywords provided by Nanjing Medical University:
Spinal anesthesia
Fluid therapy

Additional relevant MeSH terms:
Anesthetics
Hetastarch
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Plasma Substitutes
Blood Substitutes
Hematologic Agents

ClinicalTrials.gov processed this record on July 24, 2014