Maternal and Neonatal Outcomes of the Use of Vasopressors to Treat Hypotension During Spinal Anesthesia for Cesarean

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2011 by Instituto Materno Infantil Prof. Fernando Figueira.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Flavia orange, Instituto Materno Infantil Prof. Fernando Figueira
ClinicalTrials.gov Identifier:
NCT01451060
First received: August 1, 2011
Last updated: October 13, 2011
Last verified: October 2011
  Purpose

Anesthesia for cesarean section has been a great challenge for the anesthesiologist, for mother and fetus are closely related. So the challenge is to anesthetize the mother without interfering with the physiology of the fetus. The spinal block, although safe, are not free of complications if not treated properly, may be responsible for increased fetal morbidity. Among the major side effects, there is hypotension, with potentially serious consequences for the maternal-fetal dyad. Hypotension in pregnant women at low risk may not lead to major damage, but a pregnant woman with low reserves, as is the case of pregnant women with pre-eclampsia, any drop in blood pressure of the mother can bring harm to the welfare of mother and fetus. Based on the above, the purpose of this study is to compare the effects of maternal and perinatal treatment of hypotension with ephedrine or metaraminol in pregnant women with severe preeclampsia undergoing cesarean section under spinal anesthesia. There will be a randomized, double-blind, which will be included pregnant women with severe preeclampsia with indication of cesarean section, gestational age above 34 weeks gestation and only.Will be Excluded women with hemorrhagic syndromes of pregnancy, HELLP syndrome, eclampsia, cardiovascular or cerebrovascular disease, fetal distress and absolute contraindications to spinal anesthesia.

All patients are fully informed of the research objectives and will only be included in the study if they agree to participate and sign the Instrument of Consent. The project was designed following the recommendations of Resolution 196/96 of the National Health and the Declaration of Helsinki for research involving human subjects (2000). In addition, the project was submitted to the Ethics Committee in Research of the Institute of Integrative Medicine Professor Fernando Figueira, is approved. The study will be conducted from June 2011 to July 2012. The study variables are: consumption of metaraminol and ephedrine before and after birth, the occurrence of nausea and vomiting, incidence of maternal hypotension, the occurrence of reactive hypertension, occurrence of bradycardia, pH of umbilical cord, Apgar score 5 minutes, need for face mask ventilation and ICU admission.


Condition Intervention Phase
Preeclampsia
Pregnancy Toxemias
Drug: Metaraminol
Drug: Ephedrine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Maternal and Neonatal Outcomes After the Use of Vasopressors to Correct Hypotension During Cesarean Section Under Spinal Anesthesia in Pregnant Women With Severe Preeclampsia: Randomized Clinical Trial

Resource links provided by NLM:


Further study details as provided by Instituto Materno Infantil Prof. Fernando Figueira:

Primary Outcome Measures:
  • Incidence of maternal hypotension [ Time Frame: During the caesarean, on average during the first 30 minutes after spinal anesthesia ] [ Designated as safety issue: Yes ]
    Participants are accompanied throughout their cesarean section an avarage of 30 minutes, where they will be measured blood pressure and heart rate every three minutes until the end of cesarean section.


Secondary Outcome Measures:
  • Maternal and Neonatal outcomes [ Time Frame: During the cesarean section and postpartum until discharge (an average of 24 hours) ] [ Designated as safety issue: Yes ]
    After the birth of neonatal up to the high infant, an average of 30 days


Estimated Enrollment: 55
Study Start Date: June 2011
Estimated Study Completion Date: July 2012
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Metaraminol
    It will be used a dose of 0.5 mg to any fall in blood pressure of the fetus until birth
    Other Name: Aramin
    Drug: Ephedrine
    It will be used at any one dose de1mg fall in blood pressure of the fetus until birth
    Other Name: Ephedrin
Detailed Description:

Ephedrine, a long time was considered the safest drug for both mother and fetus during the treatment of hypotension in Caesarean section. However, recent evidence shows that contrary to what was thought, ephedrine appears to increase fetal metabolism, decreasing the pH and excess base.

Recently, phenylephrine has been used in the treatment of hypotension during cesarean delivery with better results in relation to acid-base parameters in umbilical cord blood. However, few data are available on the use of phenylephrine in high-risk pregnancy, the majority of studies in healthy pregnant women for elective caesarean section.

Although little scientific evidence regarding the use of metaraminol for treatment of hypotension in Caesarean section, recent study demonstrated superiority of this drug compared to ephedrine, checking a lower incidence of neonatal acidosis and better control of blood pressure. The researchers also found differences in blood gases from the umbilical cord between the ephedrine and metaraminol groups larger than those already found in previous studies comparing ephedrine and phenylephrine.

The pathophysiological changes in patients with pre-eclampsia can lead to intrauterine growth restriction with chronic fetal distress, due to the limited uteroplacental flow, which, in certain situations, may be reduced by 50% to 70%. Added to this, spinal anesthesia may cause sudden hypotension and fetal acidosis more often, even in elective operations, compared to epidural or general anesthesia, and that these changes may not have clinical significance in healthy fetuses at term, but may be critical in situations where arterial insufficiency uteroplacental and fetal distress already to present. It is believed, therefore, important that treat or prevent hypotension in patients with severe preeclampsia under spinal anesthesia.

Prevention of hypotension in patients with severe preeclampsia does not require large amounts of intravenous fluids, but careful prophylaxis of postural hypotensive syndrome. Despite the care, if hypotension occurs, aggressive treatment is mandatory in these patients and fast in order to avoid worsening fetal distress and neonatal depression. Such patients are more sensitive to vasopressors, therefore, small doses should be administered.

However, the biggest challenge of the anesthesiologist is to determine the ideal vasopressor in pregnant women at high risk, able to adequately restore blood pressure levels without determining deterioration of fetal status.

30 Reynolds and Seed in 2005 showed that ephedrine, administered in large doses, has contributed to the adverse effects of spinal anesthesia (greater degree of fetal metabolic acidosis), supporting the idea that ephedrine is not the vasopressor of choice for treatment of maternal hypotension during cesarean section.

As a result, this study is to fill this knowledge gap, taking on great importance to evaluate maternal and perinatal outcomes of pregnant women with severe preeclampsia to receive ephedrine or metaraminol for treatment of maternal hypotension during caesarean section under spinal anesthesia. Considering the importance of creating a protocol, since the metaraminol, unlike phenylephrine, is widely available at our facility.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Severe preeclampsia with indication of cesarean section
  • Informed consent for study participation
  • Age above 34 weeks gestational
  • Single Pregnancy

Exclusion Criteria:

  • Hemorrhagic syndromes of pregnancy (placenta previa, DPPNI)
  • Help Syndrome
  • Eclampsia
  • Cardiovascular or Cerebrovascular Disease
  • Fetal distress Absolute contraindications to spinal anesthesia (coagulopathy, sepsis and hypovolemia)
  • Pregnant unable to decide on participation in the study (unconscious, confused, coma, mental retardation)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01451060

Contacts
Contact: Flavia Orange, PhD 558132668177 orangeflavia@gmail.com
Contact: Viviane Maranhão, MD 558191045184 vivianemaranhao@yahoo.com.br

Locations
Brazil
Instituto de Medicina Integral Professor Fernando Figueira Recruiting
Recife, Pernambuco, Brazil, 52050050
Contact: Leila Katz, PhD    558188585977    katzleila@yahoo.com.br   
Contact: Melania Amorim, PhD    558188221514    melamorim@uol.com.br   
Principal Investigator: Flavia Orange, PhD         
Sponsors and Collaborators
Instituto Materno Infantil Prof. Fernando Figueira
Investigators
Study Director: Antonio Monteiro, MD Instituto de Medicina integral Professor Fernando Figueira
  More Information

No publications provided

Responsible Party: Flavia orange, Principal Investigator, Instituto Materno Infantil Prof. Fernando Figueira
ClinicalTrials.gov Identifier: NCT01451060     History of Changes
Other Study ID Numbers: 2300-11
Study First Received: August 1, 2011
Last Updated: October 13, 2011
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by Instituto Materno Infantil Prof. Fernando Figueira:
vasopressors
cesarean anesthesia
hypotension

Additional relevant MeSH terms:
Hypotension
Pre-Eclampsia
Toxemia
Vascular Diseases
Cardiovascular Diseases
Hypertension, Pregnancy-Induced
Pregnancy Complications
Infection
Anesthetics
Ephedrine
Metaraminol
Vasoconstrictor Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Central Nervous System Stimulants
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Cardiovascular Agents
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic alpha-1 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists

ClinicalTrials.gov processed this record on April 17, 2014