NCT01451060: Vasopressors

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

Withdrawn Phase 3 Last updated 6 September 2016

What this trial tests

Phase 3 trial testing Metaraminol in Preeclampsia. Withdrawn.

Timeline

1 June 2011

Primary endpoint
1 June 2014

1 July 2014

Quick facts

Lead sponsor	Instituto Materno Infantil Prof. Fernando Figueira
Phase	Phase 3
Status	Withdrawn
Study type	INTERVENTIONAL
Allocation	randomized
Design	single group
Masking	double
Primary purpose	treatment
Start date	1 June 2011
Primary completion	1 June 2014
Estimated completion	1 July 2014
Sites	1 location across Brazil

Drugs / interventions tested

• Metaraminol (METARAMINOL) — full drug profile →
• Ephedrine (EPHEDRINE) — full drug profile →

Conditions studied

• Preeclampsia — all drugs for Preeclampsia →
• Pregnancy Toxemias — all drugs for Pregnancy Toxemias →

Sponsor

Instituto Materno Infantil Prof. Fernando Figueira

Who can join

Adults 18 to 45, female only, with Preeclampsia or Pregnancy Toxemias. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Incidence of maternal hypotension
  Time frame: During the caesarean, on average during the first 30 minutes after spinal anesthesia
  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.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.