An observational study in Preeclampsia, sponsored by Shaare Zedek Medical Center. Status unknown at 1 site in Israel. Open to female participants. Per ClinicalTrials.gov, last updated 2022-02-11.
Sponsored by Shaare Zedek Medical Center · Observational
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.
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.
882 studies on the registry are indexed under Pre-Eclampsia; 237 are open to participants now.
This study's planned enrollment of 1,500 is above the median of 163 across 380 observational studies indexed under Pre-Eclampsia.
Browse Pre-Eclampsia studies →Shaare Zedek Medical Center is the lead sponsor of 191 studies on the registry; 17 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Parturient with diagnosis of preeclampsia that delivered by cesarean section.
Exclusion Criteria:
Type of Anesthesia
Final Type of Anesthesia for Cesarean Section including General or Regional Anesthesia
Time frame: Final Type of Anesthesia will be defined during the Cesarean Section (during the operation)
Perioperative anesthetic management
Different issues of perioperative anesthetic management including aspiration prophylaxis, airway management, induction, maintenance and emergence from anesthesia. Perioperative anesthetic management issues including: 1. Aspiration prophylaxis use: Yes/No; type of medication used. 2. Airway management: Videolaryngoscopy use: Yes/No; number of attempts. 3. Induction phase of anesthesia: type of antihypertensive medication, hypnotics, opiates, and neuromuscular blocking agent. 4. Maintenance phase of anesthesia: type of volatile anesthetics, nitrous oxide or TIVA technique. 5. Emergence phase of anesthesia: type of neuromuscular reversal agent.
Time frame: Beginning from preoperative assessment by anesthesiologist to discharge from Post-Anesthesia Care Unit (PACU) / ICU (Intensive Care Unit) assessed up to 5 days
Postoperative pain management
Postoperative pain management according to the visual analog scale (VAS) (0 - no pain to 10 - worst pain)
Time frame: From the start of surgery to the end of postoperative care in recovery unit assessed up to 5 days
Invasive monitoring use
Invasive monitoring use during Cesarean Section
Time frame: During surgery
Anesthetic complications
Description of Anesthetic complications
Time frame: Anesthetic complications of patient as result of anesthetic management during the surgery until discharge from the hospital, assessed up to 5 days
Admission to ICU unit
Admission to Intensive Care Unit (ICU) unit (Yes/No) and duration of admission (days)
Time frame: Admission to during current hospitalization and until discharge from the hospital, assessed up to 5 days
Use of blood products
Type of blood product administered in perioperative period: RBC - Yes/No; FFP - Yes/No; PLT - Yes/No; CRYO - Yes/No. Total amount of each blood product units administered during perioperative period.
Time frame: Type and total amount of blood products that administered to patient during the surgery and during the hospitalization, assessed up to 5 days
Indication for surgery
Indication for Cesarean Section
Time frame: Indication for Cesarean Section will be defined by obstetrician before the operation
Obstetric complications
Specific obstetric and maternal complications
Time frame: Obstetric complications of patient during the surgery until discharge from the hospital, assessed up to 5 days
Apgar score
Apgar score at 1 and 5 minutes. Apgar score was published by Virginia Apgar. Measured from 0 to 10. The maximum score is a 10, the lowest score is a 0. Scores a 7 or above is considered in good health, while scores under a 7 may require immediate medical care.
Time frame: Will be defined at 1 and 5 minute after fetal delivery during surgery
Admission to NICU
Number of neonates that required admission to Neonatal Intensive Care Unit (NICU). According to decision of neonatologist that presented during the operation
Time frame: Admission to NICU unit during the surgery until maternal discharge from the hospital, assessed up to 5 days
Neonatal complications
Neonatal complications
Time frame: Neonatal complications during the surgery until maternal discharge from the hospital, assessed up to 5 days
Plan to share: No
This study is status unknown, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.
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Shaare Zedek Medical Center