This trial is active, not recruiting.

Condition preeclampsia
Treatments ephedrine, phenylephrine, metaraminol
Sponsor University of Sao Paulo General Hospital
Start date July 2014
End date July 2014
Trial size 60 participants
Trial identifier NCT02245191, VASPRES-3


It is a prospective clinical trial with random distribution that intends to investigate maternal and fetal effects of ephedrine, phenylephrine and metaraminol during cesarean delivery in patients with pre-eclampsia.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose diagnostic
Patients who will receive ephedrine after spinal anesthesia
5mg after Spinal Anesthesia
Patients who will receive Phenylephrine after spinal anesthesia
100mcg after Spinal Anesthesia
Patients who will receive Metaraminol after spinal anesthesia
200mcg Metaraminol after Spinal Anesthesia

Primary Outcomes

Middle cerebral artery pulsatility index changes before and after spinal anesthesia and vasopressor use.
time frame: One year
Maternal cardiac output changes after vasopressor (ephedrine, phenylephrine or metaraminol) use in pregnant patients under spinal anesthesia
time frame: One year
Uterine arterial pulsatility index changes before and after spinal anesthesia and vasopressor use.
time frame: One year
Umbilical arterial pulsatility index changes before an after spinal anesthesia and vasopressor use
time frame: One year

Eligibility Criteria

Female participants at least 18 years old.

Inclusion Criteria: - Preeclampsia patients - After 34 weeks pregnant Exclusion Criteria: - Patients' refusal - Obstetric Emergency - Contraindications to spinal anesthesia - Obesity

Additional Information

Official title Ephedrine, Phenylephrine and Metaraminol Effects on Maternal Cardiac Output, Uterine Blood Flow and Fetal Circulation in Patients With Preeclampsia Under Spinal Anesthesia for Cesarean
Description Spinal anesthesia has become the main anesthetic technique for cesarean delivery due to avoidance of failed tracheal intubation risk, improvement of post-operative analgesia and promotion of early mother-neonate bonding. Spinal anesthesia should be safe and comfortable for mother and child when referring to the side effects, including hypotension. The choice of the best vasopressor in this context is approaching to a resolution, favoring phenylephrine use. However, studies on high-risk pregnancies are still required, such as uteroplacental insufficiency, preeclampsia and intra-uterine growth restriction cases. The purpose of this study is to compare the effects of the vasopressors ephedrine, phenylephrine and metaraminol on maternal cardiac output, uteroplacental and cerebral fetal blood flow in patients with preeclampsia under spinal anesthesia for cesarean delivery. Sixty pregnant patients will be recruited and randomly assigned to receive either ephedrine, phenylephrine or metaraminol, making a total of three groups with 20 patients each. Variables to be analyzed are uterine arterial pulsatility index, umbilical arterial pulsatility index, fetus middle cerebral artery pulsatility index, maternal cardiac output, maternal cardiac frequency, maternal mean arterial blood pressure and maternal peripheral vascular resistance. These variables will be recorded in three moments: before the spinal anesthesia with the patient in dorsal recumbent and left displacement of the uterus, after spinal anesthesia in dorsal recumbent and after vasopressor bolus. Averages will be calculated in these intervals and then compared to the alteration caused by spinal anesthesia and the return to basal levels after drug intervention.
Trial information was received from ClinicalTrials.gov and was last updated in September 2014.
Information provided to ClinicalTrials.gov by University of Sao Paulo General Hospital.