Clinical trial NCT05237011: Peripartum Anesthetic Management of Patients With Preeclampsia
Official title: Peripartum Anesthetic Management of Patients With Preeclampsia: Prospective Cohort International Observational Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Preeclampsia
Keywords: Obstetric Anesthesia
Anesthetic Management
Preeclampsia
Regional Anesthesia
Complication
Lead sponsor: Shaare Zedek Medical Center
Sponsor class: OTHER
First posted: 2022-02-11
Enrollment: 1500
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Parturient with diagnosis of preeclampsia that delivered by cesarean section.

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.

Eligibility criteria: Inclusion Criteria:

* Parturient with diagnosis of preeclampsia for Cesarean Section

Exclusion Criteria:

* No

Primary outcomes:
measure: Type of Anesthesia
timeFrame: Final Type of Anesthesia will be defined during the Cesarean Section (during the operation)
Secondary outcomes:
measure: Perioperative anesthetic management
timeFrame: Beginning from preoperative assessment by anesthesiologist to discharge from Post-Anesthesia Care Unit (PACU) / ICU (Intensive Care Unit) assessed up to 5 days
measure: Postoperative pain management
timeFrame: From the start of surgery to the end of postoperative care in recovery unit assessed up to 5 days
measure: Invasive monitoring use
timeFrame: During surgery
measure: Anesthetic complications
timeFrame: Anesthetic complications of patient as result of anesthetic management during the surgery until discharge from the hospital, assessed up to 5 days
measure: Admission to ICU unit
timeFrame: Admission to during current hospitalization and until discharge from the hospital, assessed up to 5 days
measure: Use of blood products
timeFrame: Type and total amount of blood products that administered to patient during the surgery and during the hospitalization, assessed up to 5 days
measure: Indication for surgery
timeFrame: Indication for Cesarean Section will be defined by obstetrician before the operation
measure: Obstetric complications
timeFrame: Obstetric complications of patient during the surgery until discharge from the hospital, assessed up to 5 days
measure: Apgar score
timeFrame: Will be defined at 1 and 5 minute after fetal delivery during surgery
measure: Admission to NICU
timeFrame: Admission to NICU unit during the surgery until maternal discharge from the hospital, assessed up to 5 days
measure: Neonatal complications
timeFrame: Neonatal complications during the surgery until maternal discharge from the hospital, assessed up to 5 days
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Shaare Zedek Meedical Center
Study officials:
References:
citation: Siddiqui MM, Banayan JM, Hofer JE. Pre-eclampsia through the eyes of the obstetrician and anesthesiologist. Int J Obstet Anesth. 2019 Nov;40:140-148. doi: 10.1016/j.ijoa.2019.04.002. Epub 2019 Apr 13.
citation: Hodgkinson R, Husain FJ, Hayashi RH. Systemic and pulmonary blood pressure during caesarean section in parturients with gestational hypertension. Can Anaesth Soc J. 1980 Jul;27(4):389-94. doi: 10.1007/BF03007461. No abstract available.
citation: Ring L, Landau R, Delgado C. The Current Role of General Anesthesia for Cesarean Delivery. Curr Anesthesiol Rep. 2021;11(1):18-27. doi: 10.1007/s40140-021-00437-6. Epub 2021 Feb 24.
citation: Lee LO, Bateman BT, Kheterpal S, Klumpner TT, Housey M, Aziz MF, Hand KW, MacEachern M, Goodier CG, Bernstein J, Bauer ME; Multicenter Perioperative Outcomes Group Investigators. Risk of Epidural Hematoma after Neuraxial Techniques in Thrombocytopenic Parturients: A Report from the Multicenter Perioperative Outcomes Group. Anesthesiology. 2017 Jun;126(6):1053-1063. doi: 10.1097/ALN.0000000000001630.
citation: Hutcheon JA, Lisonkova S, Joseph KS. Epidemiology of pre-eclampsia and the other hypertensive disorders of pregnancy. Best Pract Res Clin Obstet Gynaecol. 2011 Aug;25(4):391-403. doi: 10.1016/j.bpobgyn.2011.01.006. Epub 2011 Feb 18.