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

Preeclampsia research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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)

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Preeclampsia

Pregnancy Toxemias

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:MetaraminolIt will be used a dose of 0.5 mg to any fall in blood pressure of the fetus until birth

Drug:EphedrineIt will be used at any one dose de1mg fall in blood pressure of the fetus until birth

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Study Status

Withdrawn

Start Date: June 2011

Completed Date: July 2014

Phase: Phase 3

Type: Interventional

Design:

Primary Outcome: Incidence of maternal hypotension

Secondary Outcome: Maternal and Neonatal outcomes

Study sponsors, principal investigator, and references

Principal Investigator: Antonio Monteiro, MD

Lead Sponsor: Instituto Materno Infantil Prof. Fernando Figueira

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01451060

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