Skip to main content
OpenTrials
Completed

NCT Number: NCT00991627

Different Approaches to Maternal Hypotension During Cesarean Section

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Pregnancy Anesthesia,Spinal Cardiovascular Diseases Cesarean Section Hypotension Pathological Conditions, Signs and Symptoms Signs and Symptoms Vascular Diseases

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

University and Hospital of Parma (Azienda Ospedaliero-Universitaria di Parma)

Parma, PR, 43126, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bupivacaine

Drug

10 mg of a 5 mg/ml hyperbaric solution, intrathecally

Other names: Marcain, Local Anesthetic

Morphine

Drug

200 µg of a 100 µg/ml solution, intrathecally

Other names: Intrathecal morphine

Lactated Ringer's solution

Drug

25 ml/min intravenously

Ephedrine, continuous infusion

Drug

37.5 mg/h intravenously

Ephedrine, bolus

Drug

6.25 mg IV bolus prn.

Hypotension defined according to study protocol for each arm.

Atropine

Drug

0.1 mg/kg iv bolus prn

Bradycardia defined as 50% drop in heart rate from baseline values.

Primary outcomes

  1. Neonatal arterial base excess

    Time frame: <5 min from birth

Secondary outcomes

  1. Neonatal arterial and venous pH, venous base excess

    Time frame: <5 min from birth

  2. Apgar score

    Time frame: 1 and 5 minutes from birth

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

    Time frame: Baseline and up to 12 h postoperatively

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

    Time frame: q5min from anesthesia to end of surgery

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

    Time frame: q5min from anesthesia to end of surgery

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

    Time frame: q5min from anesthesia to end of surgery

  7. Administered atropine

    Time frame: from anesthesia to end of surgery

  8. Amount of ephedrine administered (mg)

    Time frame: from anesthesia to end of surgery

  9. Time between induction of anesthesia and skin incision

  10. Time between skin incision and delivery

Sponsors and collaborators

Lead sponsor

University of Parma

Other

Collaborators

  • Azienda Ospedaliero-Universitaria di Parma

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Oct 8, 2009
Registry last updated
Aug 27, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.