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OpenTrials
Completed

NCT Number: NCT00977769

Carbetocin Versus Oxytocin and Hemodynamic Effects

A randomized double-blind trial of oxytocin 5 u, carbetocin 100 µg and placebo with hemodynamic response as a primary outcome measure.

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Key information

Conditions

Effects of; Anesthesia, in Pregnancy

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Division of Anaesthesia and Intensive Care Medicine, Oslo University Hospital - Rikshospitalet, Oslo, Norway

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About this study

Healthy pregnant women sheduled for elective cesarean section. Invasive hemodynmaic monitoring with LiDCO Plus.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy pregnant women for planned cesarean section

Exclusion criteria

  • Bleeding disorders
  • Placenta disorders

Treatment and study plan

carbetocin 100 µg

Drug

Hemodynamic effect of

Other names: Pabal, injection

oxytocin 5 u

Drug

Hemodynamic effect of

Other names: Syntocinon, injection

placebo (NaCl)

Drug

Hemodynamic effect of

Other names: Saline, injection

Primary outcomes

  1. Cardiac Output

    Time frame: 2.5 minutes

    The relative change in CO from baseline at the time of delivery up to 2.5 minutes post delivery.

  2. Arterial Blood Pressure

    Time frame: 2.5 min

    The mean change in SAP compared with baseline at the time of delivery up to 2.5 minutes post delivery.

Secondary outcomes

  1. Bleeding

    Time frame: 120 minutes

    The calculated estimated blood loss from delivery until 2 h after intervention

Sponsors and collaborators

Lead sponsor

Oslo University Hospital

Other

Registry information

Official study title

Hemodynamic Effects of Carbetocin 100 µg, Oxytocin 5 U or Placebo After Cesarean Delivery Under Spinal Anesthesia in Healthy Pregnant Women.

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Sep 16, 2009
Registry last updated
May 6, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.