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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT01451060
Other study ID # 2300-11
Secondary ID
Status Withdrawn
Phase Phase 3
First received August 1, 2011
Last updated September 6, 2016
Start date June 2011
Est. completion date July 2014

Study information

Verified date October 2011
Source Instituto Materno Infantil Prof. Fernando Figueira
Contact n/a
Is FDA regulated No
Health authority Brazil: National Committee of Ethics in Research
Study type Interventional

Clinical Trial Summary

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.


Description:

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Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment


Intervention

Drug:
Metaraminol
It will be used a dose of 0.5 mg to any fall in blood pressure of the fetus until birth
Ephedrine
It will be used at any one dose de1mg fall in blood pressure of the fetus until birth

Locations

Country Name City State
Brazil Instituto de Medicina Integral Professor Fernando Figueira Recife Pernambuco

Sponsors (1)

Lead Sponsor Collaborator
Instituto Materno Infantil Prof. Fernando Figueira

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence of maternal hypotension Participants are accompanied throughout their cesarean section an average of 30 minutes, where they will be measured blood pressure and heart rate every three minutes until the end of cesarean section. During the caesarean, on average during the first 30 minutes after spinal anesthesia Yes
Secondary Maternal and Neonatal outcomes After the birth of neonatal up to the high infant, an average of 30 days During the cesarean section and postpartum until discharge (an average of 24 hours) Yes
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