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

NCT01451060 | Withdrawn Phase 3 DMC

• 1 other identifier: 2300-11
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Preeclampsia; Pregnancy Toxemias

Keywords

vasopressors; cesarean anesthesia; hypotension

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Maternal and Neonatal outcomes

  During the cesarean section and postpartum until discharge (an average of 24 hours)

Interventions

Metaraminol DRUG

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

Also known as: Aramin

Ephedrine DRUG

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

Also known as: Ephedrin

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Instituto Materno Infantil Prof. Fernando Figueira: lead

Study Sites (1)

Instituto de Medicina Integral Professor Fernando Figueira

Recife, Pernambuco, 52050050, Brazil

Location

MeSH Terms

Conditions

Pre-Eclampsia; Hypotension

Interventions

Metaraminol; Ephedrine

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Phenylpropanolamine; Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Phenethylamines; Ethylamines

Study Officials

• Antonio Monteiro, MD

  Instituto de Medicina integral Professor Fernando Figueira

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 1, 2011
• First Posted: October 13, 2011
• Study Start: June 1, 2011
• Primary Completion: June 1, 2014
• Study Completion: July 1, 2014
• Last Updated: September 7, 2016

Record last verified: 2011-10

Data Sharing

• IPD Sharing: Will share

Locations

BR (1)