Hemodynamic Monitoring in Obstetrics

NCT03755271 | Completed

• 1 other identifier: 1/2018/PO
• Study Type: observational
• Target: 148
• Locations: 1 country
• Sites: 1

Brief Summary

Spinal anesthesia has long been considered the first choice technique in caesarean section, but although it is a reliable and safe procedure, it is in some cases associated with undesirable effects. Maternal hypotension after sub-arachnoid anesthesia is a reduction in systolic blood pressure below 100 mmHg or a decrease of 20% compared to baseline values. According to some authors, maternal hypotension occurs up to 80% in women undergoing caesarean section after spinal anesthesia. In order to reduce the incidence of maternal hypotension, some measures can be taken:

• a reduction of aorto-caval compression by manual displacement of the uterus on the left;
• hemodynamic monitoring;
• administration of fluids;
• optimization of the dosage of the local anesthetic;
• use of vasopressors. The main objective of the study is to investigate, through the use of a continuous non-invasive hemodynamic monitoring system (Clearsight® - Edwards Lifesciences), the incidence of hypotension in pregnant women at risk undergoing spinal anesthesia due to elective cesarean section.

Conditions

Hypotension

Keywords

Intraoperative hypotension; Caesarean section; Spinal anesthesia

Outcome Measures

Primary Outcomes (1)

• Incidence of hypotension assessed through the use of the non-invasive hemodynamic monitoring system ClearSight

  Intraoperatively

Secondary Outcomes (26)

• Modifications of Stroke Volume (SV) from basal

  2 minutes after spinal anesthesia

• Modifications of Stroke Volume (SV) from basal

  4 minutes after spinal anesthesia

• Modifications of Stroke Volume (SV) from basal

  6 minutes after spinal anesthesia

• Modifications of Stroke Volume (SV) from basal

  8 minutes after spinal anesthesia

• Modifications of Stroke Volume (SV) from basal

  2 minutes after cutaneous incision

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

148 pregnant women, at risk of developing hypotension, undergoing spinal anesthesia for elective Caesarean section at the Universitary Hospital "G. Rodolico" of Catania

You may qualify if:

• Age between 18 and 40 years
• American Society of Anesthesiologists (ASA) Classification I-II
• Positive Postural Change Test (PCT)
• Signature of informed consent

You may not qualify if:

• Age less than 18 years or above 40 years
• American Society of Anesthesiologists (ASA) Classification III-V
• Negative Postural Change Test (PCT)
• Refusal by the parturients to sign the informed consent

Sponsors & Collaborators

• University of Catania: lead
• Marinella Astuto: collaborator
• Carmelo Minardi: collaborator
• Mirko Mineri: collaborator
• Francesco Vasile: collaborator
• Gaetano Joseph Palumbo: collaborator

Study Sites (1)

"G. Rodolico" Presidium of the Azienda Ospedaliero Universitaria "Policlinico-Vittorio Emanuele"

Catania, 95123, Italy

Location

MeSH Terms

Conditions

Hypotension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Paolo Murabito, MD

  University of Catania

  PRINCIPAL INVESTIGATOR

• Marinella Astuto, MD

  University of Catania

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: November 19, 2018
• First Posted: November 27, 2018
• Study Start: March 2, 2018
• Primary Completion: July 20, 2018
• Study Completion: July 20, 2018
• Last Updated: November 27, 2018

Record last verified: 2018-11

Locations

IT (1)