DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



Different Approaches to Maternal Hypotension During Cesarean Section

Information source: University of Parma
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Pregnancy; Cesarean Section; Anesthesia,Spinal; Hypotension

Intervention: Bupivacaine (Drug); Morphine (Drug); Lactated Ringer's solution (Drug); Ephedrine, continuous infusion (Drug); Ephedrine, bolus (Drug); Atropine (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: University of Parma

Official(s) and/or principal investigator(s):
Guido Fanelli, MD, Study Chair, Affiliation: Dept. of Anesthesiology and Critical Care Medicine, University of Parma, Italy
Andrea Cornini, MD, Study Director, Affiliation: UO II Anestesia, Rianimazione e Terapia Antalgica, Azienda Ospedaliero-Universitaria di Parma
Michele Zasa, MD, Principal Investigator, Affiliation: Dept. of Anesthesiology and Critical Care Medicine, University of Parma, Italy

Summary

The aim of this study is to compare two different therapeutic approaches to blood pressure reduction: pharmacological vs. non-pharmacological. The setting is that of patients undergoing scheduled Cesarean section under spinal anesthesia and suffering from aorta-caval compression syndrome, which causes a sudden drop in blood pressure.

Clinical Details

Official title: Pharmacological or Non-Pharmacological Management of Maternal Hypotension During Elective Cesarean Section Under Subarachnoid Anesthesia: a Randomized, Controlled Trial

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Neonatal arterial base excess

Secondary outcome:

Neonatal arterial and venous pH, venous base excess

Apgar score

Maternal serum levels of cardiac troponin (baseline, immediate postsurgery, 6 and 12 hours after surgery)

Incidence of maternal hypotension ( <20% baseline or mean arterial pressure <60 mmHg).

Incidence of maternal bradycardia (heart rate <30% of baseline or <60 beats per minute)

Peripheral arterial oxygen saturation: incidence of desaturation (SpO2 <92%) and mean values for each arm.

Administered atropine

Amount of ephedrine administered (mg)

Time between induction of anesthesia and skin incision

Time between skin incision and delivery

Detailed description: The supine hypotensive syndrome of pregnancy is induced by compression of the inferior caval vein by the enlarged uterus. It occurs in approximately 8% of pregnant women at term. More patients may develop an asymptomatic variety of this syndrome in the supine position. The hypotensive effect of spinal anesthesia per se may thus be aggravated in a significant number of term parturients. A preoperative supine stress test (SST) before elective cesarean section under spinal anesthesia has been shown to predict severe systolic hypotension with reasonable accuracy. Different strategies have been proposed for the management of this complication; they can be divided into pharmacological and non-pharmacological ones. According to pharmacological strategies, vasoactive drugs are used to treat hypotension induced by sympathetic efferent blockade following spinal anesthesia. To this end, α-agonist ephedrine is commonly considered the best choice because of its minimal impact on the fetoplacental circulation. However, excessive use of ephedrine may be detrimental to neonatal well-being because of its vasoconstrictor effect on fetoplacental circulation. Non-pharmacological treatments may represent a valuable, safer alternative. According to many authors non-pharmacological treatments aimed at removing the cause of aorta-caval compression syndrome are to be preferred because more appropriate from an etiopathogenetic point of view. The use of a wedge-shaped cushion placed under the right hip is a well-known non-pharmacological strategy which allows the uterine left lateral displacement and, consequently, the removing of the compression from the inferior vena cava. The aim of the present study is to compare, through the evaluation of neonatal well-being, the efficacy of these approaches to hypotension after spinal anesthesia for elective Caesarean section in parturients affected by aorto-caval compression.

Eligibility

Minimum age: 18 Years. Maximum age: 50 Years. Gender(s): Female.

Criteria:

Inclusion Criteria:

- Patients undergoing spinal anesthesia for elective Cesarean section

- Patients in ASA Physical Status Class I or II

- Informed written consent to participation

- Positive Supine Stress Test

Exclusion Criteria:

- Any known fetal pathology

- Indication to general anesthesia

- Known allergy to any of the study drugs

Locations and Contacts

University and Hospital of Parma (Azienda Ospedaliero-Universitaria di Parma), Parma, PR 43126, Italy
Additional Information

Related publications:

Kinsella SM, Lohmann G. Supine hypotensive syndrome. Obstet Gynecol. 1994 May;83(5 Pt 1):774-88. Review.

Cyna AM, Andrew M, Emmett RS, Middleton P, Simmons SW. Techniques for preventing hypotension during spinal anaesthesia for caesarean section. Cochrane Database Syst Rev. 2006 Oct 18;(4):CD002251. Review.

Kinsella SM, Norris MC. Advance prediction of hypotension at cesarean delivery under spinal anesthesia. Int J Obstet Anesth. 1996 Jan;5(1):3-7.

Helwig JT, Parer JT, Kilpatrick SJ, Laros RK Jr. Umbilical cord blood acid-base state: what is normal? Am J Obstet Gynecol. 1996 Jun;174(6):1807-12; discussion 1812-4.

Starting date: September 2009
Last updated: August 26, 2010

Page last updated: August 20, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017