Peripartum Anesthetic Management of Patients With Preeclampsia

Status Not yet recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05237011
Study type	Observational
Source	Shaare Zedek Medical Center
Contact	Alexander Ioscovich, M.D.
Phone	+972508685052
Email	aioscovich@gmail.com
Status	Not yet recruiting
Phase
Start date	February 1, 2022
Completion date	January 1, 2023

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT03510286` - Validation of a PrCr Dipstick Diagnostic Test in Ghana
Recruiting	`NCT03313024` - Berlin-Brandenburg Pregnancy Cohort
Active, not recruiting	`NCT04990141` - Molecular Screening Method for Preeclampsia (PREMOM)
Completed	`NCT02147626` - Heart Health 4 Moms Trial to Reduce CVD Risk After Preeclampsia	N/A
Not yet recruiting	`NCT05999851` - Multiparametric Assessment of Maternal Vascular Function in the Prediction of Hypertensive Disorders of Pregnancy	N/A
Recruiting	`NCT02923206` - Proof-of-Concept Trial on Selective Removal of sFlt-1 in Pregnant Women With Preeclampsia Via Apheresis	N/A
Terminated	`NCT02558023` - The Treatment of Hypertension Associated With Severe Preeclampsia (PE). A Trial of Urapidil Versus Nicardipine	Phase 3
Withdrawn	`NCT05016440` - Lisinopril for Renal Protection in Postpartum Preeclamptic Women	N/A
Completed	`NCT02854501` - Second Trimester Maternal Serum Homocysteine Levels and Uterine Artery Doppler for Prediction of Preeclampsia and Placentation Disorders
Not yet recruiting	`NCT02541110` - Prediction of Preeclampsia & Other Obstetric Complications by Serum Homocysteine & Doppler	N/A
Completed	`NCT02384226` - User Testing and Feedback for a Mobile Health Program for Postpartum Women: A Pilot Study
Completed	`NCT02554604` - Identifying HDL Composition and Function in Preeclamptic and Normal Pregnancies
Recruiting	`NCT02337049` - Preeclampsia Subtypes and Surrogate Markers of CVD Risk	N/A
Recruiting	`NCT02247297` - Pancreatic Stone Protein (PSP) in Pregnant Women
Completed	`NCT02238704` - Cornell University-Micronutrient Initiative Calcium Supplementation Study	N/A
Completed	`NCT01195441` - Prediction and Prevention of Preeclampsia by First Trimester Ultrasound	N/A
Withdrawn	`NCT01179542` - The Involvement of Eukaryotic Translation Initiation Factor 4E (eIF4E) in Human Placental Implantation and in the Pathological Pregnancies: Preeclampsia and IUGR	N/A
Completed	`NCT00456118` - Study of the Role of Tissular Maternofetal Alloimmunization in Placentation Pathologies
Recruiting	`NCT00117546` - Cardiovascular and Autonomic Reactivity in Women With a History of Pre-eclampsia	Phase 4
Completed	`NCT00787241` - Platelet Count Trends in Pre-eclamptic Parturients	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.