Recruiting

Hydroxyethylstarch

Sponsor:

Maisonneuve-Rosemont Hospital

Code:

NCT01415284

Conditions

Obstetric Anesthesia

Spinal Anesthesia

Hypotension

Fluid Therapy

Cesarean Section

Eligibility Criteria

Sex: Female

Age: 0+

Healthy Volunteers: Not accepted

Interventions

Hydroxyethylstarch 130/0.4

Study Details

Brief summary:

The purpose of this trial is to determine the effective volume of hydroxyethylstarch 130/0.4 which would prevent the occurence of maternal hypotension in 50% of healthy pregnant women undergoing a cesarean section under spinal anesthesia.

Conditions

Obstetric Anesthesia

Spinal Anesthesia

Hypotension

Fluid Therapy

Cesarean Section

Study ID

NCT01415284

Start date

Oct, 2011

Status verified date

Feb, 2013

Completion date

Jun, 2013

Anticipated

Primary completion date

Jun, 2013

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 0+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Healthy pregnant women (ASA I or II)
  • Normal pregnancy
  • Term gestation (37 weeks and above)
  • Elective cesarean section
  • Spinal anesthesia

Exclusion Criteria:

  • Cardiopathies
  • Hypertensive disease/ pre-eclampsia / eclampsia
  • Any contraindication to neuraxial anesthesia
  • Patient refusal
  • Body mass index > 30 at first antenatal visit and > 32 at cesarean section
  • Twin pregnancy
  • Known allergies to HES
  • Emergency cesarean section

Study Design

Enrollment

30 participants

Anticipated

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Hydroxyethylstarch 130/0.4

Interventions

Hydroxyethylstarch 130/0.4

first patient : 500 mL. Following volumes according to up-down sequential allocation, with increments or decrements of 100 mL. An absence of hypotension will lead to an decrement while a presence of hypotension will result in an increment.

Primary outcome measure

  • Volume of HES which will prevent hypotension if 50 % of the subjects. [ Time Frame: 4 months ]

Central Contacts and Locations

Central contacts

Christian Loubert, MD, FRCPC

514.252.3426loubertch@yahoo.fr

Louis-Philippe Fortier, MD, FRCPC

514.252.3426lpfortier@mac.com

Locations

Maisonneuve-Rosemont Hospital

Recruiting

Montreal, Quebec, Canada, H1T 2M4

Contacts

Christian Loubert, MD, FRCPC

514.252.3426loubertch@yahoo.fr

Louis-Philippe Fortier, MD, FRCPC

514.252.3426lpfortier@mac.com

Principal Investigator:

Christian Loubert, MD, FRCPC

More Information

Sponsor

Maisonneuve-Rosemont Hospital

Last update posted

Feb 15, 2013

Last verified

Feb, 2013

Keywords

  • Obstetric anesthesia
  • Spinal anesthesia
  • Hypotension
  • Fluid therapy
  • Cesarean section
  • phenylephrine
  • cardiac output

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Maisonneuve-Rosemont Hospital on 2013-02-15.