Peripartum Anesthetic Management of Patients With Preeclampsia
- Conditions
- Preeclampsia
- Registration Number
- NCT05237011
- Lead Sponsor
- Shaare Zedek Medical Center
- Brief 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 1500
- Parturient with diagnosis of preeclampsia for Cesarean Section
- No
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Type of Anesthesia Final Type of Anesthesia will be defined during the Cesarean Section (during the operation) Final Type of Anesthesia for Cesarean Section including General or Regional Anesthesia
- Secondary Outcome Measures
Name Time Method Perioperative anesthetic management Beginning from preoperative assessment by anesthesiologist to discharge from Post-Anesthesia Care Unit (PACU) / ICU (Intensive Care Unit) assessed up to 5 days 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.Postoperative pain management From the start of surgery to the end of postoperative care in recovery unit assessed up to 5 days Postoperative pain management according to the visual analog scale (VAS) (0 - no pain to 10 - worst pain)
Invasive monitoring use During surgery Invasive monitoring use during Cesarean Section
Anesthetic complications Anesthetic complications of patient as result of anesthetic management during the surgery until discharge from the hospital, assessed up to 5 days Description of Anesthetic complications
Apgar score Will be defined at 1 and 5 minute after fetal delivery during surgery 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.
Admission to ICU unit Admission to during current hospitalization and until discharge from the hospital, assessed up to 5 days Admission to Intensive Care Unit (ICU) unit (Yes/No) and duration of admission (days)
Use of blood products Type and total amount of blood products that administered to patient during the surgery and during the hospitalization, assessed up to 5 days 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.Indication for surgery Indication for Cesarean Section will be defined by obstetrician before the operation Indication for Cesarean Section
Obstetric complications Obstetric complications of patient during the surgery until discharge from the hospital, assessed up to 5 days Specific obstetric and maternal complications
Admission to NICU Admission to NICU unit during the surgery until maternal discharge from the hospital, assessed up to 5 days Number of neonates that required admission to Neonatal Intensive Care Unit (NICU). According to decision of neonatologist that presented during the operation
Neonatal complications Neonatal complications during the surgery until maternal discharge from the hospital, assessed up to 5 days Neonatal complications
Trial Locations
- Locations (1)
Shaare Zedek Meedical Center
🇮🇱Jerusalem, Israel