Clinical Trials Directory

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UnknownNCT05237011

Peripartum Anesthetic Management of Patients With Preeclampsia

Peripartum Anesthetic Management of Patients With Preeclampsia: Prospective Cohort International Observational Study

Status
Unknown
Phase
Study type
Observational
Enrollment
1,500 (estimated)
Sponsor
Shaare Zedek Medical Center · Academic / Other
Sex
Female
Age
Healthy volunteers
Not accepted

Summary

The investigators will conduct a prospective, observational multicentral international study of perioperative management of patients with preeclampsia. The data will be collected from the maternity files and information systems of the medical centers including obstetric, anesthetic and neonatal parameters according to the attached Excel data table. Results of the study will help to improve the management of patients with preeclampsia and will help to understand the nature and rate of complications. In addition, the study will help in comparing collected data to the data in the literature and as a result improve the safety of care and service that these patient receive in the institution.

Detailed description

In recent years, there has been a growing interest in anesthetic management of parturients diagnosed with preeclampsia. The management of patients with preeclampsia is influenced by maternal conditions that include airway changes, coagulation dysfunction and significant hemodynamic changes. Without changing regular practice the investigators will observe and collect data about: the type of anesthesia during surgery, perioperative monitoring and management of these patients (please see study outcomes). Complications reported in the literature include significant elevated blood pressure during laryngoscopy and development of intracranial hemorrhage, spinal/epidural bleeding during neuraxial anesthesia in patients with preeclampsia, and coagulation abnormalities. Although the number of patients diagnosed with preeclampsia is estimated at five to ten percent of the general maternity population, there is a lack of prospective studies regarding the anesthetic management, obstetric complications and neonatal outcomes. In most centers the data regarding the rate of general anesthesia for cesarean section, the difficulty in performing neuraxial anesthesia, complications related to coagulation dysfunction and other complications, is limited. In studies published by gynecologists or neonatologists, there is a significant lack of data relevant to the daily practice of anesthesiologists.

Conditions

Timeline

Start date
2022-02-01
Primary completion
2023-01-01
Completion
2023-01-01
First posted
2022-02-11
Last updated
2022-02-11

Locations

1 site across 1 country: Israel

Source: ClinicalTrials.gov record NCT05237011. Inclusion in this directory is not an endorsement.